Background: Despite current rehabilitation programs, long-term engagement in physical activity remains a significant challenge for patients with chronic obstructive pulmonary disease (COPD) and heart failure (HF). Novel strategies to promote physical activity in these populations are greatly needed. Emerging literature on the benefits of both mind–body interventions and web-based interventions provide the rationale for the development of the Mindful Steps intervention for increasing walking behavior.
Objective: This study aims to develop a novel multimodal mind–body exercise intervention through adaptation of an existing web-based physical activity intervention and incorporation of mind–body exercise, and to pilot test the delivery of the new intervention, Mindful Steps, in a randomized controlled feasibility trial in older adults with COPD and/or HF.
Methods: In phase 1, guided by a theoretical conceptual model and review of the literature on facilitators and barriers of physical activity in COPD and HF, we convened an expert panel of researchers, mind–body practitioners, and clinicians to inform development of the novel, multimodal intervention. In phase 2, we are conducting a pilot randomized controlled feasibility trial of the Mindful Steps intervention that includes in-person mind–body exercise classes, an educational website, online mind–body videos, and a pedometer with step-count feedback and goals to increase walking behavior in patients with COPD and/or HF. Outcomes include feasibility measures as well as patient-centered measures.
Results: The study is currently ongoing. Phase 1 intervention development was completed in March 2019, and phase 2 data collection began in April 2019.
Conclusions: Through the integration of components from a web-based physical activity intervention and mind–body exercise, we created a novel, multimodal program to impact long-term physical activity engagement for individuals with COPD and HF. This developmental work and pilot study will provide valuable information needed to design a future clinical trial assessing efficacy of this multimodal approach.
Trial Registration: ClinicalTrials.gov NCT03003780; https://clinicaltrials.gov/ct2/show/NCT03003780
International Registered Report Identifier (IRRID): DERR1-10.2196/27826
Physical activity is an important modifiable behavior that has enormous impacts on cardiopulmonary health. Chronic obstructive pulmonary disease (COPD) and heart failure (HF) are two systemic cardiopulmonary syndromes where patients experience similar morbidity and suffer debilitating decreases in physical activity. COPD, characterized by progressive airflow limitation most commonly due to environmental toxins (eg, smoking), confers considerable morbidity in up to 10% of US adults and is the third most common cause of death in the United States [, ]. HF, also a progressive syndrome, is characterized by the inability of the heart to pump efficiently to meet metabolic demands and is associated with multiple cardiovascular and metabolic derangements [ , ]. Coexistence of the 2 conditions is being increasingly recognized, with estimated rates as high as 39% [ , ].
Patients with COPD and HF are characteristically deconditioned, with impairments in exercise tolerance and increases in dyspnea. Both self-reported and directly measured physical activity is significantly reduced, even at the earliest stages of disease [- ]. During and following acute exacerbations, patients suffer further dyspnea, deconditioning, and reductions in physical activity [ - ]. Both cardiopulmonary conditions are also associated with multiple comorbidities, including anxiety, depression, and musculoskeletal disease, further contributing to reduced physical activity [ , - ]. In HF, systematic reviews and meta-analyses report that exercise training reduces HF-related hospitalizations and results in clinically important improvements in health-related quality of life (HRQL) [ , ]. Walking, the most common form of exercise in these populations, has been associated with reduced HF risk [ ]. The least active individuals with COPD have risks that are 2-6 times higher for acute exacerbations and hospitalizations than those most active [ ]. Higher physical activity in COPD is also associated with a significantly lower hospital readmission rate and mortality risk, independent of lung function [ - ]. COPD studies examining daily step count support that every step walked can positively impact disease course [ , , , ].
Unfortunately, engagement in physical activity is a universal challenge amplified in these chronic cardiopulmonary populations. Conventional center-based cardiac and pulmonary rehabilitation have been shown to improve outcomes; however, they are vastly underutilized, not accessible to the population at large, and not sustainable [- , , - ] Providers refer less than 13% of potential candidates who would benefit from pulmonary or cardiac rehabilitation [ - ], and among those who are referred, noncompletion rates are as high as 20%-40% [ , - ]. Despite improvements in exercise capacity, dyspnea, and HRQL after a typical course, benefits diminish 6-12 months after program completion [ ]. Other outpatient and home-based programs have had variable success [ - ]. Qualitative studies have identified barriers and facilitators to long-term adherence to physical activity in COPD and HF. Important themes include addressing fears, promoting confidence, implementing personalized feedback and goals, providing peer support, and fostering a conducive environment with opportunities to engage in exercise [ , ]. Walking, in particular, has been identified as simple and accessible. Within this context, there has been interest in refocusing the current paradigm from one of promoting short-term aerobic exercise in structured settings to one of sustaining long-term everyday physical activity. Novel strategies to achieve this in these cardiopulmonary populations are greatly needed.
There is a burgeoning interest and emerging literature in mind–body interventions for fostering positive behavior change and physical activity [- ]. In chronic cardiopulmonary disease, mind–body exercise, such as tai chi and yoga, may be particularly relevant [ , ]. Research has suggested that tai chi and mind–body breathing exercises are safe and feasible in older deconditioned patients and can lead to increases in HRQL, mood, exercise self-efficacy, and overall physical activity. In studies specific to COPD and HF, self-efficacy and overall empowerment have been shown to be important factors in facilitating long-term behavior change [ , ].
In addition, there is a rapidly emerging literature on use of web-based technology to promote healthy habits and behavior change [- ]. Some home-based programs and lifestyle physical activity interventions, which combine supervised and independent exercise with self-monitoring devices, such as pedometers, have shown success in increasing physical activity [ - ]. One such web-based intervention, made specifically for elderly patients with COPD, increased HRQL and physical activity (daily step counts) in the short term (4-6 months) [ , ]. This multimodal intervention (Every Step Counts) created by Moy and Richardson includes an online interactive web platform coupled with a pedometer, step goal feedback, motivational and educational content addressing barriers to exercise, and an online community forum for social support. Development of this intervention was based on the behavioral theory of self-regulation, which emphasizes an iterative process of behavior change with individualized goal setting, iterative feedback, extrinsic motivating factors, and social support [ - ]. However, in long-term follow-up (12 months), benefits from this intervention were not sustained [ ].
We hypothesized that by modifying this intervention with the addition and integration of mind–body principles, we could enhance existing key behavioral constructs and target new constructs through self-reflection, awareness, and personal transformation, which might lead to enhanced self-efficacy and the ultimate outcome of long-term adherence to walking behavior for COPD and HF. Thus, the current developmental study includes 2 phases with the following overarching aims: (1) adapt/refine the existing web-based physical activity intervention with added emphasis on mind–body principles and couple this platform with in-person mind–body exercise to create Mindful Steps; and (2) test delivery of Mindful Steps, a novel multimodal mind–body exercise intervention in a randomized feasibility trial with usual care control (N=42) in patients with COPD and/or HF.
Phase 1: Intervention Development
Based on our experience with mind–body interventions and a review of the literature on facilitators and barriers of physical activity in COPD and HF, we developed an initial conceptual framework () that combined the existing Moy and Richardson intervention with elements of a mind–body exercise program to impact long-term behavior change.
We chose self-efficacy as a key outcome of interest. According to social cognitive theory, self-efficacy is one’s confidence in the ability to perform certain health behaviors and can influence the engagement in and actual performance of those behaviors, affecting health outcomes thereby . Self-efficacy is a modifiable characteristic, and exercise self-efficacy is one of the strongest predictors of physical activity behavior [ ]. Within our conceptual model, there are multiple characteristics of mind–body exercise that reinforce and enhance constructs of self-regulation from the existing intervention and additionally provide new constructs and potential mediating factors toward self-efficacy [ - ].
Experience/goal attainment, based on traditional self-efficacy theory , refers to the notion that prior successes boost confidence and facilitate self-efficacy. For example, mind–body exercise is often described as gentle, accessible, and nonthreatening, which may allow participants to achieve goals, even if in small increments. Similarly, small individual successes in iterative step-count goals further enhance that model with repeated success. Modeling describes when participants gain from seeing others succeed and modeling others’ behaviors. Prior qualitative data, including our studies of tai chi and HF, have reinforced the value of seeing others, perhaps even in a poorer condition than oneself, achieve success, which feeds confidence and motivation for one’s own abilities [ , ]. Self-awareness and mindfulness of physiologic cues and emotional states are inherently cultivated through mind–body exercise and are at the foundation of mind–body practices. Body signals such as fast heart rate or breathing due to anxiety or fear can negatively impact one’s perception of a particular task, such as exercise or walking. This may be illustrated by the anxiety–breathlessness cycle in COPD [ ]. Strategies for mindfulness, body- and self-awareness, and concomitant acceptance and nonreactivity can mitigate this effect. Mind–body exercises can also address pain cycles and related exercise barriers [ - ] and impact fear of falling, which is correlated with self-efficacy and decreased falls [ , ]. Intrinsic motivation refers to motivation that is driven, not because of external factors (eg, a reward through an intervention website, feedback, or praise) but by internal factors, such as personal satisfaction and enjoyment. The inherent likeability of mind–body therapies is not well studied; however, numerous studies have reported qualitatively on enjoyment of mind–body exercise [ , , , ]. Certainly, increased mood with physical activity is well established. Finally, each of these potentially mediating factors are held within a larger domain of self-reflection and transformation that is a part of self-determination theory [ ]. There is a growing literature that describes personal transformative experiences that can occur with mind–body practices [44–46].
In the modified Mindful Steps intervention, we retain the original constructs of goal setting, iterative feedback, extrinsic motivation, and social support that have appeared effective for short-term adherence and additionally introduce constructs that facilitate self-reflection and personal transformation through heightened, mindful, self-awareness and intrinsic motivation that can impact overall self-efficacy and facilitate long-term physical activity behavior [, , ].
We assembled an expert panel to inform the creation and integration of a mind–body curriculum within the existing web-based platform. The panel included those with clinical and research expertise in mind–body exercise and tai chi, chronic cardiopulmonary disease (COPD and HF specialists), behavioral psychology, exercise physiology, and physical activity. We first began with open feedback from the core investigator team to develop the initial proposal for the curriculum. Using a modified Delphi process [, ], we then solicited input from the larger expert panel on issues from practical implementation (eg, optimum ratio of and integration of in-person class contact with online video to decrease participant burden, modifications for safety, use of technology) to content-specific recommendations (eg, essential components of the mind–body curriculum, how best to integrate it with existing content, modifying disease-specific educational content for HF and already existing information for COPD). After a first round expert panel group meeting, individual interviews took place in an iterative fashion to gather further input and refine the protocol. After 2 subsequent group meetings with the expert panel, we arrived at a consensus protocol outlined in the following sections.
Mindful Steps: Intervention Components
The final Mindful Steps Intervention to be pilot-tested contains 7 primary components (). Each of the components is described below, with specific information on how it was modified from the prior Moy and Richardson intervention.
|Intervention component||Description||Modifications from prior intervention||Rationale||Theoretical constructs|
|1. Pedometer–website interface with individualized step goal|
|2. Motivational/educational website content|
|3. Online forum|
|4. Mindful walking curriculum videos|
|5. Mind–body exercise video library|
|6. Live group classes|
|7. Earn your stars|
Component 1: Pedometer–Website Interface and Individualized Step-Count Goals
The pedometer–website interface and individualized step-count goal components are unchanged from the original Moy and Richardson intervention . Participants each receive a Fitbit Alta HR with a wristband and a personal account with access to the study web platform. An algorithm developed in prior studies is used to calculate individualized daily step-count goals each week, taking the average of the daily step counts from the prior week (most recent 7-day period of valid step-count data) and adding 400 steps [ , , , ]. Step-count goals do not exceed 10,000 steps per day. A graphical display of daily and weekly step counts and individual goals are highlighted on the home page allowing subjects to self-monitor progress in real time ( ). Participants are asked to wear the pedometer at all times during waking hours and to sync the device daily for up-to-date feedback. Participants are encouraged to log into the website daily and also receive an automated weekly email with their new step-count goal for the coming week. Step-count goals provide extrinsic motivation to increase walking behavior over time.
Component 2: Motivational and Educational Website Content
The Motivational Messages and Educational Tips components are practical intervention tools and strategies to promote walking, manage symptoms of disease, and overcome barriers to physical activity. Motivational Messages (weekly message, total 52) includes titles such as “Incorporating Walking into your Daily Life,” “Managing Stress and Anxiety,” “Handling Set-Backs,” and “Keep Walking Fun.” Educational Tips (one tip every other day, total 88) consists of brief education information and includes titles such as “Use Your Shortness of Breath to Pace Yourself,” “Using Your Body Posture to Help You Feel Less Short of Breath,” “When Is Muscle Soreness Good?”, “Top 10 Reasons to Walk,” and “People Who Walk More Live Longer.” Educational Tips also includes links to external, publicly available websites that provide further material to explore the proposed topic (eg, the Heart Failure Society of America website information, “What if your Breathing Symptoms Worsen,” on exercise and symptom management for HF). Both Motivational Messages and Educational Tips were further adapted to include links to Mindful Walking curriculum videos (component 4) and mind–body exercise videos (component 5) as appropriate. Additionally, the Motivational Message component was modified to include prompts throughout for mindful awareness, brief guided mindfulness practices, emotion regulation techniques to address anxiety and fear, cognitive reframing of walking from a chore to a gift, and practical information on how and where to walk safely.
Component 3: Online Forum
A private forum was available on the web platform in the original Moy and Richardson intervention, but was underused . In Mindful Steps, we aim to use the forum as an opportunity to engage participants in between live group classes (component 6). Prompts from class instructors and study staff are given to encourage dialogue and reflection on experiences with walking and further explore themes from classes, videos, Motivational Messages, and Educational Tips. The forum also provides an opportunity for participants to ask questions to the larger group, share successes and barriers to their daily walking and mindful practices, and offer helpful practical information, such as their favorite indoor walking spaces or outdoor trails. The purpose of the forum is to provide social support, social modeling of successes, and encourage community.
Component 4: Mindful Walking Video Curriculum
Based on feedback from our expert panel, we created brief (5-10 minute) videos designed to support walking as exercise, with each video centered around a particular theme (listed below).
- Introduction: Body, Mind, and Breath
- Mindful Warm-ups: Lower Body
- Motivation to Move
- Putting Joy Back into Exercise
- Rewarding Yourself with the Gift of Walking
- Mindfulness in Motion
- Mindful Warm-ups: Upper Body
- Renew Your Body with Your Breath
- Every Step Counts
- Overcoming Barriers and Challenges
- Walking for Your Mind and Spirit
- Pain Management
- Preventing Falls
- Strength and Flexibility
- Breath Awareness
- Your Body Affects Your Mind
- Stop and Smell the Roses
- Relaxation and Stress Management
- Exploring Balance in Walking
- Belly Breathing
- Rest and Recharge along the Way
- Importance of Posture
- Leg Strength
- Moderated Effort: the 70% Rule
- Mechanics of Walking
A new video populates the Mindful Steps home page weekly (total 26; videos are repeated in the second 26 weeks). The video includes a short didactic teaching on the theme followed by theme-related guided mind–body exercises. For example, the Relaxation and Stress Management video includes a short teaching on the impact that mindful breath awareness can have on stress, mood, and symptoms of dyspnea, and is followed by a guided mindful breathing practice. The video concludes by encouraging viewers to practice mindful breathing while walking and to integrate these practices into activities of daily living.
The full video curriculum provides practical tools and strategies for overcoming barriers to walking by increasing awareness of cognitive, emotional, and bodily cues, and learning skillful ways to respond to these barriers, including pausing and slowing down, acceptance and nonreactivity, meditative breathing, active relaxation, and gentle stretches that alleviate common aches and pains. One recurring theme (also present in component 2) is the reframing of walking and exercise from being a chore or burden to being a gift, emphasizing the enjoyment and pleasure of walking, and thus cultivating a shift towards intrinsically motivated walking. The videos also support the application of mindfulness and mind–body techniques to walking itself as a way to support a more enjoyable, embodied, walking experience.
Component 5: Mind–Body Exercise Video Library
A library of 13 mind–body exercise videos used in our prior tai chi trials [- ] are available on the website. These include the following: Swinging and Drumming, Swinging Up and Down, Hip and Leg Circles, Stretching Hands and Wrists, Spinal Cord Breathing, Song Breathing Shoulder Lifts, Dragon Wags Its Tail, The Fountain, Washing Your Body with Healing Energy, Renewing Your Body with Your Breath, Mindful Breathing, Belly Breathing, and Kindness Meditation. These videos reinforce the in-class learning of the mind–body exercises classes (component 6) and facilitate participants’ home practice of mind–body exercises. Collectively, the exercises include gentle aerobics, stretching, and meditative breathing, and aim to increase the range of motion and bring mindful awareness to the breath and individual parts of the body. They emphasize the importance of intention, facilitating ease and enjoyment of motion, and overall relaxation of body and mind.
Component 6: Live Group Classes
Live 75-minute group classes are offered to participants over the course of the year, with more instruction towards the beginning of the intervention period. Classes are conducted weekly for the first 6 weeks, biweekly for the next 34 weeks, and monthly for the last 12 weeks (25 total). Participants attend classes together as a cohort. The class curriculum follows themes from the Mindful Walking curriculum (component 4), including guided mindful walking, and also incorporates mind–body exercises from the video library (component 5). Classes begin and end with facilitated group discussion of class themes, exploration of barriers and successes with regard to step-count goals, and general check-ins. Classes are taught by experienced instructors who have led classes in our prior mind–body exercise clinical trials for over 10 years.
Component 7: Earn Your Stars
Earn Your Stars is an extrinsic motivational reward system to incentivize participants to stay engaged with the website content and their step-count goals. Participants can earn up to 3 stars a day for each of the following: reaching daily step-count goal, watching a video, clicking on Motivational Messages or Educational Tips. The star counter displays the total star accumulation on the individual’s home page. Small prizes (eg, US $5 gift cards) are given out when participants reach >100 and >500 stars.
Phase 2: Pilot Randomized Controlled Trial
In a pilot randomized controlled trial, we are testing the delivery of the multimodal intervention versus usual care control in patients with COPD and/or HF. In addition to study and intervention feasibility and acceptability measures, we will explore the mediating components of the mind–body exercise approach articulated in our conceptual model and assess clinically meaningful changes in self-efficacy and overall physical activity over the long term of 1 year. At Beth Israel Deaconess Medical Center, 42 participants with COPD and/or HF have been randomized in a 2:1 ratio to participate in the 1-year Mindful Steps program or to receive usual care (including verbal and written instructions to exercise).
Study Population and Recruitment
The inclusion criteria include the following: age over >40 years; clinical diagnosis of COPD, defined as either a ratio of forced expiratory volume in one second (FEV1) to forced vital capacity <0.70 or chest computed tomography evidence of emphysema, and/or clinical diagnosis of HF syndrome (with left ventricular systolic dysfunction or preserved ejection fraction, and New York Heart Association Class 1-3); medical clearance from a provider to participate in an exercise program; an active email account with the ability to check email at least weekly; and access to a computer with an internet connection, USB port, and Windows. Meanwhile, the exclusion criteria include the following: self-reported COPD or HF exacerbation in the previous 2 weeks; inability to ambulate; clinical signs of unstable cardiovascular disease; hypoxemia during 6-minute walk test (oxygen saturation <85% with supplemental oxygen); inability to collect at least 7 of 14 days of baseline step counts; current participation in a cardiac or pulmonary rehabilitation program.
To identify potential participants, we searched hospital registries, screened physician schedules, solicited direct physician referrals through email, and used targeted patient advertising (paper flyers, digital screen ads, in-person presentations) in primary care or specialty clinics at Beth Israel Deaconess Medical Center and pulmonary rehabilitation clinics in the community. This was followed by opt-in mailing and telephone outreach conducted by our research assistants.
Randomization and Intervention Delivery
As in prior studies, we used a 14-day run-in period of pedometer (Fitbit) use requiring at least 7 days of valid data (>200 steps per day) as a criterion for participants to be eligible for randomization. As the sample size is relatively small, we will use blocked randomization with varying block sizes and a computer-generated sequence of random numbers with a concealed and unpredictable allocation scheme.
Participants in the Mindful Steps intervention will receive the pedometer, access to the Mindful Steps website, and a schedule of in-person mind–body exercise classes as described in detail previously in this paper. All participants will continue pharmacological treatment and receive care through their usual providers. Participants in both groups will also receive an education handout from Harvard Health Publishing and Harvard Medical School titled “Walking for Health,” which includes information on the health benefits of walking, how to get started on a walking program, and specific walking workouts .
outlines study feasibility and intervention acceptability and adherence measures that are being tracked to inform a future larger trial.
|Outcomes and measures||Description|
|Recruitment||Track recruitment rate by site and strategy (eg, clinic visits, mailings, advertisement sites, involvement of physician, etc.)|
|Retention||Track retention rate with acceptable retention defined as <20% dropouts|
|Qualitative interview||Semistructured interview at 6 months (in person) and 12 months (by phone) to assess patient experience, understand helpful components of the multimodal intervention, and specifically explore themes related to conceptual model|
|Physical Activity Enjoyment Scale ||8-item shortened version used to assess enjoyment of physical activity|
|MBEa adherence||Track MBE class attendance, online video tutorial use, and logs of home practice|
|Web platform usage||Track logins to the website, clicks on education links, downloads and views of videos, and pedometer use|
aMBE: mind–body exercise.
In addition, all participants will undergo testing to collect exploratory outcome measures at baseline, month 3 and 6 in-person, and month 9 and month 12 by phone.outlines exploratory patient-centered outcomes including cognitive-behavioral and psychosocial measures, overall physical activity, disease-specific HRQL and symptoms, and physical function and exercise capacity.
At each time point, we will administer questionnaires and collect physical activity data. At in-person visits only, we will additionally perform the 6-minute walk test. All tests will be conducted by study staff who will be blinded to treatment assignment. We will also track potential adverse events and COPD- and HF-related exacerbations and hospitalizations at each testing visit to assess safety.
Qualitative interviews at 6 months and 12 months will further assess facilitators and barriers to participation and acceptability of the intervention and its multiple components. Additional questions will be guided by our conceptual model and explore themes of motivation, goal attainment, social support, self-reflection, and personal transformation.
|Cognitive–behavioral and psychosocial|
|Self-Efficacy for Exercise Scale ||9-item validated scale from McAuley’s original barriers scale|
|Self-Efficacy for Managing Chronic Disease Scale ||6-item subscale from the Chronic Disease Self-Management Study|
|Intrinsic Motivation Inventory ||22-item validated scale with 4 subscales: interest/enjoyment, perceived competence, perceived choice, and pressure/tension|
|Patient Activation Measure ||13-item short form validated scale from Insignia Health|
|Medical Outcomes Study Social Support Survey ||20-item validated scale with 5 subdomains of tangible support, emotional support, informational support, affectionate support, and positive social interaction|
|Multidimensional Assessment of Interoceptive Awareness ||32-item validated scale with 5 subscales of body sensations, emotional reaction/attentional response, attention regulation, mind–body integration, trusting body sensations, assessing 8 domains of body awareness|
|CES-Da ||20-item validated scale; participants with CES-D score > 20 will be referred back to primary provider for evaluation|
|Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire ||41-item validated scale with leisure, household, occupational physical activity domains; allows estimation of weekly caloric expenditure|
|Pedometer ||Step counts measured by Fitbit pedometer; device worn during waking hours except when showering/bathing|
|St. George’s Respiratory Questionnaire [, ]||Respiratory-specific extensively validated measure of HRQL; total score and subscales of activity, symptoms, and impact|
|Minnesota Living with HFc ||HF disease–specific extensively validated measure of HRQL|
|mMRCd Dyspnea scale ||5-item scale assessing breathlessness (part of BODEe index)|
|Physical function and exercise capacity|
|PROMISf Physical Function, Fatigue ||Short form 7-10 items; from NIHg toolbox PROMIS|
|6-minute walk test ||Distance walked in 6 minutes as a measure of exercise capacity, performed according to ATSh guidelines; subjects will use supplemental oxygen if already prescribed oxygen during activity|
aCES-D: Center for Epidemiological Studies Depression scale.
bHRQL: health-related quality of life.
cHF: heart failure.
dmMRC: Modified Medical Research Council.
eBODE: body-mass index, airflow obstruction, dyspnea, and exercise.
fPatient-Reported Outcomes Measurement Information System.
gNIH: National Institutes of Health.
hATS: American Thoracic Society.
For study feasibility and intervention adherence, we will use descriptive statistics to evaluate recruitment and retention rates, attendance at mind–body exercise classes, and adherence with the online intervention (web-platform usage). We will consider study retention successful if the retention rate is at least 80% and if attendance at in-person classes is at least 70% (17/25 classes). Mean scores on the Physical Activity Enjoyment Scale at each time point will be reported .
To further evaluate intervention acceptability, 6-month and 12-month qualitative interviews will be recorded and transcribed verbatim. Thematic analysis will be informed by grounded theory methods based on our semistructured questions. Transcripts will be independently coded by at least 2 separate investigators to identify emergent themes in an iterative process until thematic saturation is reached. We will particularly search for themes that may give insights into factors mediating a shift in self-efficacy towards longer-term maintenance of walking and overall physical activity.
For each patient-centered outcome, repeated measures analyses will be performed using SAS PROC MIXED to evaluate trajectories over the course of the 4 time points for each group and the differences between the groups in these trajectories at each time point. Planned paired comparisons and Cohen’s d effect sizes will also be computed to evaluate the magnitude of improvement between time points and group differences in change. These data will provide valuable information including what outcome domains and measures may demonstrate clinically meaningful changes in future models, the appropriate number of time points to use in a future clinical trial, and measures of variability within and between groups to inform the design of future studies. Measures considered sensitive to change will be those that indicate trends in improvement over time.
Mindful Steps was funded in February 2017, approved by the institutional review board at Beth Israel Deaconess Medical Center in January 2017 and at the University of Michigan in May 2017. Phase I intervention development was completed in March 2019, phase II data collection began in April 2019, and completion is expected by August 2021. A total of 41 subjects have been enrolled.
Through the integration of a web-based physical activity intervention with a mind–body video curriculum and in-person mind–body exercise, we created a novel, multimodal program with the goal of increasing long-term physical activity adherence for patients with COPD and HF. Guided by a conceptual model, the intervention aims to target multiple factors underlying behavior change that collectively act to enhance and internalize self-efficacy, which may lead to a longer-term, more sustainable shift in physical activity behavior. This pilot will provide valuable information needed to design a future clinical trial further assessing efficacy of this multimodal approach.
Grant support:This study was supported by an award from the National Center for Complementary and Integrative Health (NCCIH) at the National Institutes of Health (NIH) (R34AT009354). Dr. Yeh was supported by K24AT009465. Dr Wayne was supported by K24AT009282. Dr. Rist was supported by K01HL128791. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the NCCIH or the NIH.
Conflicts of Interest
PW is the founder and sole owner of the Tree of Life Tai Chi Center. PW’s interests were reviewed and are managed by the Brigham and Women’s Hospital and Partners HealthCare in accordance with their conflict of interest policy. No other authors have conflicts to declare. The Tree of Life Tai Chi Center did not participate in developing or administering the intervention for this study.
Peer-review report.PDF File (Adobe PDF File), 121 KB
- Mannino DM, Buist AS. Global burden of COPD: risk factors, prevalence, and future trends. Lancet 2007 Sep 01;370(9589):765-773. [CrossRef] [Medline]
- Centers for Disease ControlPrevention (CDC). Deaths from chronic obstructive pulmonary disease--United States, 2000-2005. MMWR Morb Mortal Wkly Rep 2008 Nov 14;57(45):1229-1232 [FREE Full text] [Medline]
- Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Borden WB, American Heart Association Statistics CommitteeStroke Statistics Subcommittee. Heart disease and stroke statistics--2013 update: a report from the American Heart Association. Circulation 2013 Jan 01;127(1):e6-e245 [FREE Full text] [CrossRef] [Medline]
- Goldman L, Braudwald E. Primary Cardiology. Philadelphia: W. B. Saunders; Apr 23, 2003.
- Mascarenhas J, Lourenço P, Lopes R, Azevedo A, Bettencourt P. Chronic obstructive pulmonary disease in heart failure. Prevalence, therapeutic and prognostic implications. Am Heart J 2008 Mar;155(3):521-525. [CrossRef] [Medline]
- Iversen KK, Kjaergaard J, Akkan D, Kober L, Torp-Pedersen C, Hassager C, ECHOS-Lung Function Study Group. Chronic obstructive pulmonary disease in patients admitted with heart failure. J Intern Med 2008 Oct;264(4):361-369 [FREE Full text] [CrossRef] [Medline]
- Coombs N, Stamatakis E, Lee I. Physical inactivity among older adults: Implications for life expectancy among non-overweight and overweight or obese individuals. Obesity Research & Clinical Practice 2015 Mar;9(2):175-179. [CrossRef]
- Watz H, Waschki B, Meyer T, Magnussen H. Physical activity in patients with COPD. Eur Respir J 2009 Feb;33(2):262-272 [FREE Full text] [CrossRef] [Medline]
- Pitta F, Troosters T, Spruit MA, Probst VS, Decramer M, Gosselink R. Characteristics of physical activities in daily life in chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2005 May 1;171(9):972-977. [CrossRef] [Medline]
- Van Remoortel H, Hornikx M, Demeyer H, Langer D, Burtin C, Decramer M, et al. Daily physical activity in subjects with newly diagnosed COPD. Thorax 2013 Oct;68(10):962-963 [FREE Full text] [CrossRef] [Medline]
- Hurst JR, Vestbo J, Anzueto A, Locantore N, Müllerova H, Tal-Singer R, Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) Investigators. Susceptibility to exacerbation in chronic obstructive pulmonary disease. N Engl J Med 2010 Sep 16;363(12):1128-1138. [CrossRef] [Medline]
- Pitta F, Troosters T, Probst VS, Spruit MA, Decramer M, Gosselink R. Physical activity and hospitalization for exacerbation of COPD. Chest 2006 Mar;129(3):536-544. [CrossRef] [Medline]
- Vestbo J, Hurd SS, Agustí AG, Jones PW, Vogelmeier C, Anzueto A, et al. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summa. Am J Respir Crit Care Med 2013 Feb 15;187(4):347-365. [CrossRef]
- McNamara R, McKeough Z, McKenzie D, Alison J. Physical comorbidities affect physical activity in chronic obstructive pulmonary disease: a prospective cohort study. Respirology 2014 Aug;19(6):866-872 [FREE Full text] [CrossRef] [Medline]
- Divo M, Cote C, de Torres JP, Casanova C, Marin JM, Pinto-Plata V, BODE Collaborative Group. Comorbidities and risk of mortality in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2012 Jul 15;186(2):155-161. [CrossRef] [Medline]
- Van Remoortel H, Hornikx M, Langer D, Burtin C, Everaerts S, Verhamme P, et al. Risk factors and comorbidities in the preclinical stages of chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2013 Nov 12:131112142312002. [CrossRef]
- Pandey A, Garg S, Khunger M, Darden D, Ayers C, Kumbhani DJ, et al. Dose-response relationship between physical activity and risk of heart failure: a meta-analysis. Circulation 2015 Nov 10;132(19):1786-1794. [CrossRef] [Medline]
- Cattadori G, Segurini C, Picozzi A, Padeletti L, Anzà C. Exercise and heart failure: an update. ESC Heart Fail 2018 Apr;5(2):222-232 [FREE Full text] [CrossRef] [Medline]
- LaMonte MJ, Manson JE, Chomistek AK, Larson JC, Lewis CE, Bea JW, et al. Physical activity and incidence of heart failure in postmenopausal women. JACC Heart Fail 2018 Dec;6(12):983-995 [FREE Full text] [CrossRef] [Medline]
- Moy ML, Teylan M, Weston NA, Gagnon DR, Garshick E. Daily step count predicts acute exacerbations in a US cohort with COPD. PLoS One 2013;8(4):e60400 [FREE Full text] [CrossRef] [Medline]
- Waschki B, Kirsten A, Holz O, Müller KC, Meyer T, Watz H, et al. Physical activity is the strongest predictor of all-cause mortality in patients with COPD: a prospective cohort study. Chest 2011 Aug;140(2):331-342. [CrossRef] [Medline]
- Nguyen HQ, Chu L, Amy Liu I, Lee JS, Suh D, Korotzer B, et al. Associations between physical activity and 30-day readmission risk in chronic obstructive pulmonary disease. Ann Am Thorac Soc 2014 Jun;11(5):695-705. [CrossRef] [Medline]
- Vaes AW, Garcia-Aymerich J, Marott JL, Benet M, Groenen MT, Schnohr P, et al. Changes in physical activity and all-cause mortality in COPD. Eur Respir J 2014 Nov;44(5):1199-1209 [FREE Full text] [CrossRef] [Medline]
- Garcia-Aymerich J, Lange P, Benet M, Schnohr P, Antó JM. Regular physical activity reduces hospital admission and mortality in chronic obstructive pulmonary disease: a population based cohort study. Thorax 2006 Sep;61(9):772-778 [FREE Full text] [CrossRef] [Medline]
- Moy ML, Teylan M, Weston NA, Gagnon DR, Danilack VA, Garshick E. Daily step count is associated with plasma C-reactive protein and IL-6 in a US cohort with COPD. Chest 2014 Mar 01;145(3):542-550. [CrossRef] [Medline]
- Watz H, Pitta F, Rochester CL, Garcia-Aymerich J, ZuWallack R, Troosters T, et al. An official European Respiratory Society statement on physical activity in COPD. Eur Respir J 2014 Dec;44(6):1521-1537 [FREE Full text] [CrossRef] [Medline]
- Ades PA, Keteyian SJ, Balady GJ, Houston-Miller N, Kitzman DW, Mancini DM, et al. Cardiac rehabilitation exercise and self-care for chronic heart failure. JACC Heart Fail 2013 Dec;1(6):540-547 [FREE Full text] [CrossRef] [Medline]
- Williams NH. Promoting physical activity in primary care. BMJ 2011 Nov 04;343:d6615. [CrossRef] [Medline]
- Johnston KN, Young M, Grimmer KA, Antic R, Frith PA. Barriers to, and facilitators for, referral to pulmonary rehabilitation in COPD patients from the perspective of Australian general practitioners: a qualitative study. Prim Care Respir J 2013 Sep;22(3):319-324 [FREE Full text] [CrossRef] [Medline]
- Johnston K, Grimmer-Somers K. Pulmonary rehabilitation: overwhelming evidence but lost in translation? Physiother Can 2010;62(4):368-373 [FREE Full text] [CrossRef] [Medline]
- Forman DE, Sanderson BK, Josephson RA, Raikhelkar J, Bittner V, American College of Cardiology’s Prevention of Cardiovascular Disease Section. Heart failure as a newly approved diagnosis for cardiac rehabilitation: challenges and opportunities. J Am Coll Cardiol 2015 Jun 23;65(24):2652-2659 [FREE Full text] [CrossRef] [Medline]
- Golwala H, Pandey A, Ju C, Butler J, Yancy C, Bhatt D, et al. Temporal trends and factors associated with cardiac rehabilitation referral among patients hospitalized with heart failure: findings from get with the guidelines-heart failure registry. Journal of the American College of Cardiology 2015 Mar;65(10):A1014. [CrossRef]
- McCarthy B, Casey D, Devane D, Murphy K, Murphy E, Lacasse Y. Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2015 Feb 23(2):CD003793. [CrossRef] [Medline]
- Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, et al. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med 2013 Oct 15;188(8):e13-e64. [CrossRef] [Medline]
- Keating A, Lee A, Holland AE. What prevents people with chronic obstructive pulmonary disease from attending pulmonary rehabilitation? A systematic review. Chron Respir Dis 2011;8(2):89-99 [FREE Full text] [CrossRef] [Medline]
- Fischer MJ, Scharloo M, Abbink JJ, van 't Hul AJ, van Ranst D, Rudolphus A, et al. Drop-out and attendance in pulmonary rehabilitation: the role of clinical and psychosocial variables. Respir Med 2009 Oct;103(10):1564-1571 [FREE Full text] [CrossRef] [Medline]
- Ries AL, Kaplan RM, Myers R, Prewitt LM. Maintenance after pulmonary rehabilitation in chronic lung disease: a randomized trial. Am J Respir Crit Care Med 2003 Mar 15;167(6):880-888. [CrossRef] [Medline]
- Beauchamp MK, Evans R, Janaudis-Ferreira T, Goldstein RS, Brooks D. Systematic review of supervised exercise programs after pulmonary rehabilitation in individuals with COPD. Chest 2013 Oct;144(4):1124-1133. [CrossRef] [Medline]
- Imamura S, Inagaki T, Terada J, Nagashima K, Katsura H, Tatsumi K. Long-term efficacy of pulmonary rehabilitation with home-based or low frequent maintenance programs in patients with chronic obstructive pulmonary disease: a meta-analysis. Ann Palliat Med 2020 Sep;9(5):2606-2615 [FREE Full text] [CrossRef] [Medline]
- Spencer L, McKeough Z. Maintaining the benefits following pulmonary rehabilitation: Achievable or not? Respirology 2019 Sep;24(9):909-915 [FREE Full text] [CrossRef] [Medline]
- Robinson H, Williams V, Curtis F, Bridle C, Jones AW. Facilitators and barriers to physical activity following pulmonary rehabilitation in COPD: a systematic review of qualitative studies. NPJ Prim Care Respir Med 2018 Jun 04;28(1):19 [FREE Full text] [CrossRef] [Medline]
- Okwose NC, O'Brien N, Charman S, Cassidy S, Brodie D, Bailey K, et al. Overcoming barriers to engagement and adherence to a home-based physical activity intervention for patients with heart failure: a qualitative focus group study. BMJ Open 2020 Sep 21;10(9):e036382 [FREE Full text] [CrossRef] [Medline]
- Ott MJ. JPN 2004 Jul 01;42(7):22-29. [CrossRef]
- Vago D. Mapping modalities of self-awareness in mindfulness practice: a potential mechanism for clarifying habits of mind. Ann N Y Acad Sci 2014 Jan;1307:28-42. [CrossRef] [Medline]
- Vago DR, Silbersweig DA. Self-awareness, self-regulation, and self-transcendence (S-ART): a framework for understanding the neurobiological mechanisms of mindfulness. Front Hum Neurosci 2012;6:296 [FREE Full text] [CrossRef] [Medline]
- Cramer H, Lauche R, Moebus S, Michalsen A, Langhorst J, Dobos G, et al. Predictors of health behavior change after an integrative medicine inpatient program. Int J Behav Med 2014;21(5):775-783. [CrossRef] [Medline]
- Bryan S, Pinto Zipp G, Parasher R. The effects of yoga on psychosocial variables and exercise adherence: a randomized, controlled pilot study. Altern Ther Health Med 2012;18(5):50-59. [Medline]
- Robinson H, Williams V, Curtis F, Bridle C, Jones AW. Facilitators and barriers to physical activity following pulmonary rehabilitation in COPD: a systematic review of qualitative studies. NPJ Prim Care Respir Med 2018 Jun 04;28(1):19 [FREE Full text] [CrossRef] [Medline]
- Steele BG, Belza B, Cain KC, Coppersmith J, Lakshminarayan S, Howard J, et al. A randomized clinical trial of an activity and exercise adherence intervention in chronic pulmonary disease. Arch Phys Med Rehabil 2008 Mar;89(3):404-412. [CrossRef] [Medline]
- Liu W, Wang C, Lin H, Lin S, Lee K, Lo Y, et al. Efficacy of a cell phone-based exercise programme for COPD. Eur Respir J 2008 Sep;32(3):651-659 [FREE Full text] [CrossRef] [Medline]
- Dorsch MP, Farris KB, Bleske BE, Koelling TM. A web application for self-monitoring improves symptoms in chronic systolic heart failure. Telemed J E Health 2015 Apr;21(4):267-270. [CrossRef] [Medline]
- Nolan RP, Payne AY, Ross H, White M, D'Antono B, Chan S, et al. An internet-based counseling intervention with email reminders that promotes self-care in adults with chronic heart failure: randomized controlled trial protocol. JMIR Res Protoc 2014 Jan 30;3(1):e5 [FREE Full text] [CrossRef] [Medline]
- de Blok BM, de Greef MH, ten Hacken NH, Sprenger SR, Postema K, Wempe JB. The effects of a lifestyle physical activity counseling program with feedback of a pedometer during pulmonary rehabilitation in patients with COPD: a pilot study. Patient Educ Couns 2006 Apr;61(1):48-55. [CrossRef] [Medline]
- Nguyen H, Gill DP, Wolpin S, Steele BG, Benditt JO. Pilot study of a cell phone-based exercise persistence intervention post-rehabilitation for COPD. Int J Chron Obstruct Pulmon Dis 2009;4:301-313 [FREE Full text] [CrossRef] [Medline]
- Nguyen HQ, Donesky D, Reinke LF, Wolpin S, Chyall L, Benditt JO, et al. Internet-based dyspnea self-management support for patients with chronic obstructive pulmonary disease. J Pain Symptom Manage 2013 Jul;46(1):43-55 [FREE Full text] [CrossRef] [Medline]
- Voncken-Brewster V, Tange H, Moser A, Nagykaldi Z, de Vries H, van der Weijden T. Integrating a tailored e-health self-management application for chronic obstructive pulmonary disease patients into primary care: a pilot study. BMC Fam Pract 2014 Jan 08;15:4 [FREE Full text] [CrossRef] [Medline]
- Nguyen HQ, Carrieri-Kohlman V, Rankin SH, Slaughter R, Stulbarg MS. Is Internet-based support for dyspnea self-management in patients with chronic obstructive pulmonary disease possible? Results of a pilot study. Heart Lung 2005;34(1):51-62. [CrossRef] [Medline]
- Spittaels H, De Bourdeaudhuij I, Vandelanotte C. Evaluation of a website-delivered computer-tailored intervention for increasing physical activity in the general population. Prev Med 2007 Mar;44(3):209-217. [CrossRef] [Medline]
- Burkow TM, Vognild LK, Østengen G, Johnsen E, Risberg MJ, Bratvold A, et al. Internet-enabled pulmonary rehabilitation and diabetes education in group settings at home: a preliminary study of patient acceptability. BMC Med Inform Decis Mak 2013 Mar 05;13:33 [FREE Full text] [CrossRef] [Medline]
- Carr LJ, Bartee RT, Dorozynski C, Broomfield JF, Smith ML, Smith DT. Internet-delivered behavior change program increases physical activity and improves cardiometabolic disease risk factors in sedentary adults: results of a randomized controlled trial. Prev Med 2008 May;46(5):431-438. [CrossRef] [Medline]
- Kuijpers W, Groen WG, Aaronson NK, van HWH. A systematic review of web-based interventions for patient empowerment and physical activity in chronic diseases: relevance for cancer survivors. J Med Internet Res 2013 Feb;15(2):e37 [FREE Full text] [CrossRef] [Medline]
- Richardson CR, Newton TL, Abraham JJ, Sen A, Jimbo M, Swartz AM. A meta-analysis of pedometer-based walking interventions and weight loss. Ann Fam Med 2008;6(1):69-77 [FREE Full text] [CrossRef] [Medline]
- Bravata DM, Smith-Spangler C, Sundaram V, Gienger AL, Lin N, Lewis R, et al. Using pedometers to increase physical activity and improve health: a systematic review. JAMA 2007 Nov 21;298(19):2296-2304. [CrossRef] [Medline]
- Richardson CR, Mehari KS, McIntyre LG, Janney AW, Fortlage LA, Sen A, et al. A randomized trial comparing structured and lifestyle goals in an internet-mediated walking program for people with type 2 diabetes. Int J Behav Nutr Phys Act 2007 Nov 16;4:59 [FREE Full text] [CrossRef] [Medline]
- Richardson CR, Brown BB, Foley S, Dial KS, Lowery JC. Feasibility of adding enhanced pedometer feedback to nutritional counseling for weight loss. J Med Internet Res 2005 Nov 17;7(5):e56 [FREE Full text] [CrossRef] [Medline]
- Rabinovich RA, Louvaris Z, Raste Y, Langer D, Van Remoortel H, Giavedoni S, PROactive Consortium. Validity of physical activity monitors during daily life in patients with COPD. Eur Respir J 2013 Nov;42(5):1205-1215 [FREE Full text] [CrossRef] [Medline]
- Evers KE. eHealth promotion: the use of the internet for health promotion. Am J Health Promot 2006;20(4):suppl 1-s7, iii. [CrossRef] [Medline]
- Webb TL, Joseph J, Yardley L, Michie S. Using the internet to promote health behavior change: a systematic review and meta-analysis of the impact of theoretical basis, use of behavior change techniques, and mode of delivery on efficacy. J Med Internet Res 2010 Feb;12(1):e4 [FREE Full text] [CrossRef] [Medline]
- Samoocha D, Bruinvels DJ, Elbers NA, Anema JR, van DBAJ. Effectiveness of web-based interventions on patient empowerment: a systematic review and meta-analysis. J Med Internet Res 2010 Jun;12(2):e23 [FREE Full text] [CrossRef] [Medline]
- Wan ES, Kantorowski A, Homsy D, Teylan M, Kadri R, Richardson CR, et al. Promoting physical activity in COPD: Insights from a randomized trial of a web-based intervention and pedometer use. Respir Med 2017 Sep;130:102-110 [FREE Full text] [CrossRef] [Medline]
- Wan ES, Kantorowski A, Polak M, Kadri R, Richardson CR, Gagnon DR, et al. Long-term effects of web-based pedometer-mediated intervention on COPD exacerbations. Respir Med 2020 Feb;162:105878 [FREE Full text] [CrossRef] [Medline]
- Robinson SA, Shimada SL, Quigley KS, Moy ML. A web-based physical activity intervention benefits persons with low self-efficacy in COPD: results from a randomized controlled trial. J Behav Med 2019 Dec;42(6):1082-1090. [CrossRef] [Medline]
- Moy M, Blackstock F, Nici L. Technology to enhance engagement in physical activity. In: Robinson SA, Troosters T, Moy M, editors. Enhancing Patient Engagement in Pulmonary Healthcare the Art and Science. New York: Humana Press; 2020:133-156.
- Moy ML, Collins RJ, Martinez CH, Kadri R, Roman P, Holleman RG, et al. An internet-mediated pedometer-based program improves health-related quality-of-life domains and daily step counts in COPD: a randomized controlled trial. Chest 2015 Jul;148(1):128-137 [FREE Full text] [CrossRef] [Medline]
- Moy ML, Weston NA, Wilson EJ, Hess ML, Richardson CR. A pilot study of an internet walking program and pedometer in COPD. Respir Med 2012 Sep;106(9):1342-1350 [FREE Full text] [CrossRef] [Medline]
- Boekaerts M, Pintrich PR, Zeidner M, editors. Handbook of Self-Regulation. Cambridge, MA: Academic Press; 2005.
- Cameron L, Leventhal H, Leventhal H. The Self-Regulation of Health and Illness Behaviour. London: Routledge; Jan 2003:1-352.
- Locke E, Latham G. A Theory of Goal Setting & Task Performance. Englewood Cliffs, NJ: Prentice-Hall, Inc; 1990.
- Moy ML, Martinez CH, Kadri R, Roman P, Holleman RG, Kim HM, et al. Long-term effects of an internet-mediated pedometer-based walking program for chronic obstructive pulmonary disease: randomized controlled trial. J Med Internet Res 2016 Aug 08;18(8):e215 [FREE Full text] [CrossRef] [Medline]
- Bandura A. Self-efficacy: Toward a unifying theory of behavioral change. Psychological Review 1977;84(2):191-215. [CrossRef]
- McAuley E, Szabo A, Gothe N, Olson EA. Self-efficacy: implications for physical activity, function, and functional limitations in older adults. Am J Lifestyle Med 2011 Jul;5(4):361-369 [FREE Full text] [CrossRef] [Medline]
- Fischer M, Fugate-Woods N, Wayne PM. Use of pragmatic community-based interventions to enhance recruitment and adherence in a randomized trial of Tai Chi for women with osteopenia. Menopause 2014;21(11):1181-1189. [CrossRef]
- Yang Y, Decelle S, Reed M, Rosengren K, Schlagal R, Greene J. Subjective experiences of older adults practicing taiji and qigong. J Aging Res 2011;2011:650210 [FREE Full text] [CrossRef] [Medline]
- Wu E, Barnes DE, Ackerman SL, Lee J, Chesney M, Mehling WE. Preventing Loss of Independence through Exercise (PLIÉ): qualitative analysis of a clinical trial in older adults with dementia. Aging Ment Health 2015;19(4):353-362. [CrossRef] [Medline]
- Bailey PH. The dyspnea-anxiety-dyspnea cycle--COPD patients' stories of breathlessness: "It's scary /when you can't breathe". Qual Health Res 2004 Jul;14(6):760-778. [CrossRef] [Medline]
- Chen Y, Hunt MA, Campbell KL, Peill K, Reid WD. The effect of Tai Chi on four chronic conditions-cancer, osteoarthritis, heart failure and chronic obstructive pulmonary disease: a systematic review and meta-analyses. Br J Sports Med 2016 Apr;50(7):397-407. [CrossRef] [Medline]
- Lee C, Crawford C, Hickey A, Active Self-Care Therapies for Pain (PACT) Working Group. Mind-body therapies for the self-management of chronic pain symptoms. Pain Med 2014 Apr;15 Suppl 1:S21-S39. [CrossRef] [Medline]
- Wang C, Schmid CH, Rones R, Kalish R, Yinh J, Goldenberg DL, et al. A randomized trial of tai chi for fibromyalgia. N Engl J Med 2010 Aug 19;363(8):743-754 [FREE Full text] [CrossRef] [Medline]
- Wang C, Schmid CH, Hibberd PL, Kalish R, Roubenoff R, Rones R, et al. Tai Chi is effective in treating knee osteoarthritis: a randomized controlled trial. Arthritis Rheum 2009 Nov 15;61(11):1545-1553 [FREE Full text] [CrossRef] [Medline]
- Zijlstra G, van Haastregt JCM, van Rossum E, van Eijk JTM, Yardley L, Kempen GIJM. Interventions to reduce fear of falling in community-living older people: a systematic review. J Am Geriatr Soc 2007 Apr;55(4):603-615. [CrossRef] [Medline]
- Hackney M, Wolf S. Impact of Tai Chi Chu'an practice on balance and mobility in older adults: an integrative review of 20 years of research. J Geriatr Phys Ther 2014;37(3):127-135. [CrossRef] [Medline]
- Taylor-Piliae RE, Haskell WL, Waters CM, Froelicher ES. Change in perceived psychosocial status following a 12-week Tai Chi exercise programme. J Adv Nurs 2006 May;54(3):313-329. [CrossRef] [Medline]
- Deci EL, Eghrari H, Patrick BC, Leone DR. Facilitating internalization: the self-determination theory perspective. J Pers 1994 Mar;62(1):119-142. [CrossRef] [Medline]
- Simmons LA, Wolever RQ. Integrative health coaching and motivational interviewing: synergistic approaches to behavior change in healthcare. Glob Adv Health Med 2013 Jul;2(4):28-35 [FREE Full text] [CrossRef] [Medline]
- Dalkey N, Helmer O. An experimental application of the DELPHI method to the use of experts. Management Science 1963 Apr;9(3):458-467. [CrossRef]
- Black N, Murphy M, Lamping D, McKee M, Sanderson C, Askham J, et al. Consensus development methods: a review of best practice in creating clinical guidelines. J Health Serv Res Policy 1999 Oct;4(4):236-248. [CrossRef] [Medline]
- Moy ML, Janney AW, Nguyen HQ, Matthess KR, Cohen M, Garshick E, et al. Use of pedometer and Internet-mediated walking program in patients with chronic obstructive pulmonary disease. J Rehabil Res Dev 2010;47(5):485-496 [FREE Full text] [CrossRef] [Medline]
- Krein SL, Metreger T, Kadri R, Hughes M, Kerr EA, Piette JD, et al. Veterans walk to beat back pain: study rationale, design and protocol of a randomized trial of a pedometer-based internet mediated intervention for patients with chronic low back pain. BMC Musculoskelet Disord 2010 Sep 13;11:205 [FREE Full text] [CrossRef] [Medline]
- Martinez CH, Moy ML, Nguyen HQ, Cohen M, Kadri R, Roman P, et al. Taking Healthy Steps: rationale, design and baseline characteristics of a randomized trial of a pedometer-based Internet-mediated walking program in veterans with chronic obstructive pulmonary disease. BMC Pulm Med 2014 Feb 03;14:12 [FREE Full text] [CrossRef] [Medline]
- Yeh GY, McCarthy EP, Wayne PM, Stevenson LW, Wood MJ, Forman D, et al. Tai chi exercise in patients with chronic heart failure: a randomized clinical trial. Arch Intern Med 2011 Apr 25;171(8):750-757 [FREE Full text] [CrossRef] [Medline]
- Yeh G, Roberts DH, Wayne PM, Davis RB, Quilty MT, Phillips RS. Tai chi exercise for patients with chronic obstructive pulmonary disease: a pilot study. Respir Care 2010 Nov;55(11):1475-1482 [FREE Full text] [Medline]
- Yeh GY, Wayne PM, Litrownik D, Roberts DH, Davis RB, Moy ML. Tai chi mind-body exercise in patients with COPD: study protocol for a randomized controlled trial. Trials 2014 Aug 28;15:337 [FREE Full text] [CrossRef] [Medline]
- Moy ML, Wayne PM, Litrownik D, Beach D, Klings ES, Davis RB, et al. Long-term Exercise After Pulmonary Rehabilitation (LEAP): design and rationale of a randomized controlled trial of Tai Chi. Contemp Clin Trials 2015 Nov;45(Pt B):458-467 [FREE Full text] [CrossRef] [Medline]
- Walking for health. Harvard Health Publishing. URL: https://www.health.harvard.edu/exercise-and-fitness/walking-for-health [accessed 2021-01-02]
- Mullen SP, Olson EA, Phillips SM, Szabo AN, Wójcicki TR, Mailey EL, et al. Measuring enjoyment of physical activity in older adults: invariance of the physical activity enjoyment scale (paces) across groups and time. Int J Behav Nutr Phys Act 2011 Sep 27;8:103 [FREE Full text] [CrossRef] [Medline]
- Resnick B, Jenkins LS. Testing the reliability and validity of the Self-Efficacy for Exercise scale. Nurs Res 2000;49(3):154-159. [CrossRef] [Medline]
- Lorig K, Sobel D, Ritter P, Laurent D, Hobbs M. Effect of a self-management program on patients with chronic disease. Eff Clin Pract 2001;4(6):256-262. [Medline]
- McAuley E, Duncan T, Tammen VV. Psychometric properties of the Intrinsic Motivation Inventory in a competitive sport setting: a confirmatory factor analysis. Res Q Exerc Sport 1989 Mar;60(1):48-58. [CrossRef] [Medline]
- Hibbard JH, Stockard J, Mahoney ER, Tusler M. Development of the Patient Activation Measure (PAM): conceptualizing and measuring activation in patients and consumers. Health Serv Res 2004 Aug;39(4 Pt 1):1005-1026 [FREE Full text] [CrossRef] [Medline]
- Sherbourne CD, Stewart AL. The MOS social support survey. Social Science & Medicine 1991 Jan;32(6):705-714. [CrossRef]
- Mehling WE, Price C, Daubenmier JJ, Acree M, Bartmess E, Stewart A. The Multidimensional Assessment of Interoceptive Awareness (MAIA). PLoS One 2012;7(11):e48230 [FREE Full text] [CrossRef] [Medline]
- Radloff LS. The CES-D Scale: a self-report depression scale for research in the general population. Applied Psychological Measurement 2016 Jul 26;1(3):385-401. [CrossRef]
- Stewart AL, Mills KM, King AC, Haskell WL, Gillis D, Ritter PL. CHAMPS physical activity questionnaire for older adults: outcomes for interventions. Med Sci Sports Exerc 2001 Jul;33(7):1126-1141. [CrossRef] [Medline]
- Matthews CE, Hagströmer M, Pober DM, Bowles HR. Best practices for using physical activity monitors in population-based research. Med Sci Sports Exerc 2012 Jan;44(1 Suppl 1):S68-S76 [FREE Full text] [CrossRef] [Medline]
- Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-complete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire. Am Rev Respir Dis 1992 Jun;145(6):1321-1327. [CrossRef] [Medline]
- Jones PW. St. George's Respiratory Questionnaire: MCID. COPD 2005 Mar;2(1):75-79. [CrossRef] [Medline]
- Rector TS, Cohn JN. Assessment of patient outcome with the Minnesota Living with Heart Failure questionnaire: Reliability and validity during a randomized, double-blind, placebo-controlled trial of pimobendan. American Heart Journal 1992 Oct;124(4):1017-1025 [FREE Full text] [CrossRef]
- Munari AB, Gulart AA, Dos Santos K, Venâncio RS, Karloh M, Mayer AF. Modified medical research council dyspnea scale in GOLD classification better reflects physical activities of daily living. Respir Care 2018 Jan;63(1):77-85 [FREE Full text] [CrossRef] [Medline]
- Rose M, Bjorner J, Becker J, Fries J, Ware J. Evaluation of a preliminary physical function item bank supported the expected advantages of the Patient-Reported Outcomes Measurement Information System (PROMIS). J Clin Epidemiol 2008 Jan;61(1):17-33. [CrossRef] [Medline]
- Rasekaba T, Lee A, Naughton M, Williams T, Holland A. The six-minute walk test: a useful metric for the cardiopulmonary patient. Intern Med J 2009 Aug;39(8):495-501. [CrossRef] [Medline]
|COPD: chronic obstructive pulmonary disease|
|HRQL: health-related quality of life|
|HF: heart failure|
Edited by T Derrick; This paper was peer reviewed by the National Institutes for Health funding committee. See the Multimedia Appendix for the peer-review report; submitted 09.02.21; accepted 22.02.21; published 29.04.21Copyright
©Daniel Litrownik, Elizabeth A Gilliam, Peter M Wayne, Caroline R Richardson, Reema Kadri, Pamela M Rist, Marilyn L Moy, Gloria Y Yeh. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 29.04.2021.
This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.