UAB Research Collaborative
Birmingham, Alabama, 35209, United States
NCT Number: NCT03797378
The purpose of this study is to test the effects of an innovative exercise program referred to as movement-2-music (M2M) on health and fitness outcomes in adults with physical/mobility disabilities. One hundred and eight participants with physical/mobility disabilities will be recruited and randomly enrolled into one of two groups: a) M2M or b) waitlist control. The primary aim of this study is to determine the effects of a 12-week M2M program on health and fitness in participants with physical/mobility disabilities who are in one of three functional mobility groups: 1) Group I - only able to exercise while sitting, 2) Group II - able to exercise sitting and standing with/without support, and 3) Group III - able to exercise one side of the body more than the other side. The second aim is to compare the observed effects of the program in this study to a previous M2M study that groups participants based on disability type. The third aim of this study is to test whether adherence (defined as attendance to the 12-week program) affects the effects of M2M in participants with physical/mobility disabilities. The potential influences of different functional mobility and disabilities of participants on how the program affects participants' health and fitness outcomes will also be tested.
**In response to COVID-19, the 12-week M2M intervention and all assessments have been modified from being delivered in-person at Lakeshore Foundation to being delivered remotely in real-time through videoconferencing technology.**
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Birmingham, Alabama, 35209, United States
The proposed intervention efficacy trial examines a remotely-delivered, rhythmic-based movement-2-music (eM2M) intervention with 108 adults with physical/mobility disabilities who are randomized into one of two groups: a) eM2M or b) waitlist control. The primary aim is to determine the effects of a 12-week eM2M intervention on physical and psychosocial health outcomes in participants with physical/mobility disabilities who are classified into three functional mobility groups: 1) Group I - only able to exercise while sitting, 2) Group II - able to exercise sitting and standing with/without support, and 3) Group III - able to exercise one side of the body more than the other side. The secondary aim is to compare effect sizes of the physical health outcomes including cardiorespiratory fitness, muscle strength and lower extremity function obtained in the current study to a previous M2M trial that grouped participants based on disability type. The tertiary aim of this study is to explore whether adherence (defined in terms of attendance to the 12-week intervention) moderates effects of eM2M in participants with physical/mobility disabilities. The heterogeneity of treatment effect across the physical health outcomes will also be examined using functional mobility and disability groups as moderators.
Participants will complete a set of assessments at baseline and after the 12-week intervention period remotely through videoconferencing technology. They will also be asked to complete the questionnaire portion of the assessments every 6 months and the entire set of assessments every year for up to 5 years. The assessments include cardiorespiratory fitness measured using a heart rate recovery test, grip strength measured using hand-held dynamometer, lower extremity function measured using the Short Physical Performance Battery and the Timed Up and Go test as well as questionnaires that assess health-related quality of life (NIH PROMIS 10 Global Health Items, NIH PROMIS Ability to Participate in Social Roles and Activities), physical activity (Godin Leisure Time Exercise Questionnaire), exercise self-efficacy (Exercise Self-efficacy Scale), exercise goal-setting (Exercise Goal-setting Scale), outcome expectation for exercise (Multidimensional Outcomes Expectations for Exercise Scale), social support (Social Provision Scale) and barriers in physical activity (Barriers in Physical Activity Questionnaire). In addition, at the end of the 12-week intervention, participants will be interviewed about their study experience and perceived impact of eM2M on their fitness and health.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The eM2M intervention involves three 60-minute sessions per week for 12 weeks. All sessions are delivered remotely in real-time through videoconferencing technology. The intervention uses combinations of movement patterns that target range of motion, muscle strength, cardiorespiratory fitness, balance, and breathing. Each session consists of movement routines choreographed to music, and every routine can be adapted to participants' functional ability.
Time frame: Baseline and post 12-week intervention
The cardiorespiratory fitness is measured using a heart rate recovery test
Time frame: Baseline and post 12-week intervention
Muscle strength is measured with grip strength using a hand-held dynamometer.
Time frame: Baseline and post 12-week intervention
Lower extremity function is assessed using the Short Physical Performance Battery (SPPB)
Time frame: Baseline and post 12-week intervention
Lower extremity function will be assessed using the Timed Up and Go (TUG) test.
Time frame: Baseline and post 12-week intervention
Health-related quality of life is measured using the National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Items. The instrument is a 10-item measure with the response scores ranging from 1 (very severe) to 5 (none). Two summary scores, a global physical health score and a global mental health score, can be calculated from this scale, with each score ranging from 4 to 20. Higher scores indicate better health. The total raw score is translated into a T-score for each participant for analysis.
Time frame: Baseline and post 12-week intervention
Social participation is measured using the National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities. The instrument is a 8-item measure with the response scores ranging from 1 (always) to 5 (never). The lowest possible total raw score is 8 and the highest possible score is 40. Higher scores indicate better ability to participate in social roles and activities. The total raw score is translated into a T-score for each participant for analysis.
Time frame: Baseline and post 12-week intervention
Physical activity is measured using the Godin Leisure Time Exercise Questionnaire. The questionnaire contains two questions. The first question asks participants to report weekly frequencies of activities they perform at different intensities. A total weekly leisure activity is a sum of activity scores calculated by multiplying the weekly frequencies of strenuous, moderate, and light activities by 9, 5, and 3, respectively. The second question asks participants the frequency of weekly leisure-time activities performed that are long enough to work up a sweat.
Time frame: Baseline and post 12-week intervention
Barriers in physical activity will be assessed using the Barriers in Physical Activity Questionnaire. The instrument contains 43 items. Each item is responded with either no (1) or yes (2). If response is yes, a follow-up response that ranges from 1 (very small) to 5 (very large) is selected. There are 8 domains, which include personal health, attitudes/beliefs towards physical activity, friends, family, fitness center built environment, policy/programs/staff, community built environment, and safety. Each domain score is calculated by summing the item responses with its respective item weight. Higher domain scores indicate greater perceived barriers to physical activity.
Time frame: Baseline and post 12-week intervention
Exercise self-efficacy will be assessed using the Exercise Self-Efficacy Scale. The scale contains 8 items, with response options of each item ranging from 0% (not at all confident) to 100% (highly confident). All items are summed and a mean score is calculated. Higher scores indicate higher levels of self-efficacy.
Time frame: Baseline and post 12-week intervention
Exercise goal-setting will be measured using the Exercise Goal-Setting Scale. The instrument contains 10 items with response options ranging from 1 (does not describe) to 5 (describes completely). A mean score is calculated. A higher mean score indicate better goal-setting and self-monitoring for exercise.
Time frame: Baseline and post 12-week intervention
Outcome expectations for exercise will be assessed using the Multidimensional Outcome Expectations for Exercise Scale. The instrument contains 15 items, with the response options ranging from 1 (strongly disagree) to 5 (strongly agree). Three domains of outcome expectations for exercise are assessed, which include physical outcome expectations (6 items), social outcome expectations (4 items), and self-evaluative outcome expectations (5 items). Each dimension is scored by summing the item responses. Higher scores indicate higher levels of outcome expectations for exercise.
Time frame: Baseline and post 12-week intervention
Social support will be assessed using the Social Provision Scale. The instrument contains 24 items, with the response options ranging from 1 (strongly disagree) to 4 (strongly agree). A total score is calculated by summing scores from all items. A higher score indicates a greater degree of perceived support.
University of Alabama at Birmingham
Other
The M2M LEADERS Project: Lakeshore Examination of Activity, Disability, and Exercise Response Study (LEADERS)
Acronym: M2M LEADERS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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