The M2M LEADERS Project: Lakeshore Examination of Activity, Disability, and Exercise Response Study (LEADERS)

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.