Clinical trial NCT03797378: Movement-2-Music: Lakeshore Examination of Activity, Disability, and Exercise Response Study
Official title: The M2M LEADERS Project: Lakeshore Examination of Activity, Disability, and Exercise Response Study (LEADERS)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Traumatic Brain Injury
Spina Bifida
Cerebral Palsy
Stroke
Parkinson Disease
Multiple Sclerosis
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Lakeshore Foundation
name: YMCA of Greater Birmingham
First posted: 2019-01-09
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.\*\*

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of head injury, stroke, multiple sclerosis, spinal cord injury, spina bifida, Parkinson disease, cerebral palsy by a physician
* Able to use upper limbs and/or lower limbs to exercise and follow instructions
* Physician clearance to participate
* Willing to participate in an exercise program three times per week
* Conversant in and reads English

Exclusion Criteria:

* Participate in an exercise intervention or a similar intervention in the last 6 months
* Current smoker or recently quit less than 6 months prior
* Cognitive impairment (Folstein's Mini-Mental State Exam score \<24)
* Presence of active pressure ulcer
* Any contraindications to exercise based on the American College of Sports Medicine (ACSM) guidelines
* Visual acuity that prevents following a group exercise class
* Significant hearing impairment impeding ability to hear music to engage in exercise

Primary outcomes:
measure: Change from baseline cardiorespiratory fitness at 3 months
timeFrame: Baseline and post 12-week intervention
measure: Change from baseline muscle strength at 3 months
timeFrame: Baseline and post 12-week intervention
Secondary outcomes:
measure: Change from baseline lower extremity function at 3 months
timeFrame: Baseline and post 12-week intervention
measure: Change from baseline lower extremity function at 3 months
timeFrame: Baseline and post 12-week intervention
measure: Change from baseline health-related quality of life at 3 months
timeFrame: Baseline and post 12-week intervention
measure: Change from baseline social participation at 3 months
timeFrame: Baseline and post 12-week intervention
measure: Change from baseline physical activity at 3 months
timeFrame: Baseline and post 12-week intervention
Other outcomes:
measure: Change from baseline barriers in physical activity at 3 months
timeFrame: Baseline and post 12-week intervention
measure: Change from baseline exercise self-efficacy at 3 months
timeFrame: Baseline and post 12-week intervention
measure: Change from baseline exercise goal-setting at 3 months
timeFrame: Baseline and post 12-week intervention
measure: Change from baseline outcome expectations for exercise at 3 months
timeFrame: Baseline and post 12-week intervention
measure: Change from baseline social support at 3 months
timeFrame: Baseline and post 12-week intervention
Locations:
city: Birmingham
country: United States
facility: UAB Research Collaborative
state: Alabama
Study officials:
References:
citation: Young HJ, Lai B, Mehta T, Thirumalai M, Wilroy J, Yates A, Kane B, Rimmer JH. The movement-to-music (M2M) study: study protocol for a randomized controlled efficacy trial examining a rhythmic teleexercise intervention for people with physical disabilities. Trials. 2021 Nov 7;22(1):779. doi: 10.1186/s13063-021-05751-2.