Effectiveness of a 16-Week Multimodal Exercise Program on Individuals With Dementia: Study Protocol for a Multicenter Randomized Controlled Trial

Background The increasing prevalence of dementia in the next decades is accompanied by various societal and economic problems. Previous studies have suggested that physical activity positively affects motor and cognitive skills in individuals with dementia (IWD). However, there is insufficient evidence probably related to several methodological limitations. Moreover, to date adequate physical activity interventions specifically developed for IWD are lacking. Objective This study aims to investigate the effectiveness of a multimodal exercise program (MEP) on motor and cognitive skills in IWD in a high-quality multicenter trial. Methods A multicenter randomized controlled trial with baseline and postassessments will be performed. It is planned to enroll 405 participants with dementia of mild to moderate stage, aged 65 years and older. The intervention group will participate in a 16-week ritualized MEP especially developed for IWD. The effectiveness of the MEP on the primary outcomes balance, mobility, and gait will be examined using a comprehensive test battery. Secondary outcomes are strength and function of lower limbs, activities of daily living, and cognition (overall cognition, language, processing speed, learning and memory, and visual spatial cognition). Results Enrollment for the study started in May 2015. It is planned to complete postassessments by the beginning of 2017. Results are expected to be available in the first half of 2017. Conclusions This study will contribute to enhancing evidence for the effects of physical activity on motor and cognitive skills in IWD. Compared to previous studies, this study is characterized by a dementia-specific intervention based on scientific knowledge, a combination of motor and cognitive tasks in the intervention, and high standards regarding methodology. Findings are highly relevant to influence the multiple motor and cognitive impairments of IWD who are often participating in limited physical activity. Trial Registration German Clinical Trials Register DRKS00010538; https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00010538 (Archived by WebCite at http://www.webcitation.org/6oVGMbbMD)


6-meter walk test (mobility) [53]
The 6-meter walk test [53] assesses mobility and aims to capture normal gait speed. To reduce bias caused by the testing situation, participants are not explicitly informed about time keeping. A straight and flat distance of 6 meters is marked. During time keeping, investigators try to avoid conversation. All walking aids used in everyday life are applied. The 6-meter walk test is repeated 2 or 3 times if necessary.

GAITRite (gait parameters)
Temporal and spatial gait parameters will be analyzed using the electronic gait analysis system GAITRite (CIR Systems Inc, Franklin, NJ) with an active length of 4.88 meters, a spatial resolution of 1.27 centimeters, and a scan rate of 120 hertz. Gait parameters are recorded for 3 different conditions: walking with normal speed; walking with normal speed and the task of counting backwards from 50; walking with normal speed and the task of naming animals. All conditions will be repeated up to 5 times walking in the same direction to generate 3 valid trials. All walking aids used in everyday life are applied. To eliminate acceleration and deceleration during recording, participants start walking 2 meters in front of the GAITRite system and end 2 meters after [80]. Rests between trials are allowed when necessary.
Participants are asked to stand up and sit down as often as possible during 30 seconds.
Repetitions are counted loudly. Moreover, the time to perform 5 repetitions is taken during the modified 30-second chair-stand test. In this modified version participants are allowed to use their arms [54,55]. The chair is the same as in timed Up and Go test (sitting height of 46 centimeters, with armrests). Investigators demonstrate the task and participants complete 1 test run. Valid performances, defined as hip angle during standing of about 180° and during sitting of about 90°, are counted after the command "Go" with simultaneous timing up to 30 seconds. If 30 seconds end while standing, a semi repetition is counted. After a rest, fit participants complete a second trial without using arms with the same recording procedure as for the modified 30-second chair-stand test (including time for 5 repetitions).

Short physical performance battery (function of lower limbs) [56]
The short physical performance battery [56] evaluates function of lower limbs. It consists of standing balance (Romberg, semi tandem, tandem), gait speed, and 5 times sit to stand without using arms [56]. All measures are described above.

Erlangen Test of Activities of Daily Living (E-ADL-Test) (Activities of Daily Living) [59]
Erlangen Test of Activities of Daily Living (E-ADL-Test) [59] determines ADL. It consists of 5 items: pouring a drink, cutting a piece of bread, opening a small cupboard, washing hands, and tying a bow which will be performed during testing. A detailed description of each item is given by Graessel et al [59].

7-item physical performance test (Activities of Daily Living) [60]
The 7-item physical performance test [60] assess ADLs and includes the following tasks: writing a sentence, simulated eating, turning 360 degrees, putting on and removing a jacket, lifting a book and putting it on a shelf, picking up a penny from the floor, and a 50-foot walk test. The 7-item physical performance test will be performed according to the test protocol given by Reuben and Siu [60]. Due to time restrictions and to reduce physical stress, the 50-foot walk test will not be performed in this high-aged sample and the gait speed of the 6-meter walk test will be used instead.

Cognitive Assessments
All cognitive assessments will be performed and rated according to available test protocols.

Body mass and height
Body mass and height will be measured using a Seca 813 Robusta scale and Seca 213 stadiometer (Seca, Hamburg, Germany) with an accuracy of 0.1 kilogram and 0.1 centimeter, respectively. Participants will wear normal clothes and shoes during all measurements and the shoe type will be documented.