Movement-2-Music Exercise Program for Mobility Disabilities

(M2M LEADERS Trial)

Recruiting at 1 trial location

Overseen By Alex Yates, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Cognitive impairment, Active pressure ulcer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 42

Duration: 12 weeks

108 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.\*\*

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is the Movement-2-Music Exercise Program safe for people with mobility disabilities?

The Movement-2-Music (M2M) program has been studied as a home-based exercise intervention for people with physical and mobility disabilities, and no specific safety concerns have been reported in the available research. ^{1 2 3 4 5}

How is the Movement-2-Music treatment different from other treatments for mobility disabilities?

The Movement-2-Music treatment is unique because it is a home-based exercise program that combines rhythmic music with movement, making it enjoyable and accessible for people with mobility disabilities. Unlike traditional exercise programs, it is delivered remotely, eliminating barriers like transportation and time commitment, and is tailored to individual functional levels. ^{1 4 6 7 8}

What data supports the effectiveness of the Movement-2-Music treatment for mobility disabilities?

The Movement-2-Music program is designed to be enjoyable and accessible for people with physical disabilities, addressing common barriers like transportation and time. Similar structured physical activity programs have shown benefits in improving mobility and reducing disability in older adults, suggesting potential effectiveness for this treatment. ^{1 3 9 10 11}

Are You a Good Fit for This Trial?

This trial is for adults with physical disabilities like multiple sclerosis, traumatic brain injury, cerebral palsy, spinal cord injury, Parkinson's disease, stroke or spina bifida. Participants must be able to exercise using their limbs and follow instructions in English. They need a doctor's approval to join but can't take part if they have significant hearing loss, poor vision that affects group activities, recent smoking history or cognitive impairments.

Inclusion Criteria

I can use my arms and/or legs to exercise and follow directions.

Physician clearance to participate

Conversant in and reads English

Exclusion Criteria

You have trouble hearing music, which affects your ability to exercise.

You are currently smoking or quit less than 6 months ago.

I cannot follow a group exercise class due to poor eyesight.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 12-week eM2M intervention with three 60-minute sessions per week delivered remotely

12 weeks

36 sessions (remote)

Follow-up

Participants are monitored for health and fitness outcomes through assessments every 6 months and annually for up to 5 years

5 years

Remote assessments every 6 months and annually

What Are the Treatments Tested in This Trial?

Interventions

• Movement-2-Music

Trial Overview The study tests an exercise program called movement-2-music (M2M), comparing it against a waitlist control over 12 weeks. It aims to improve health and fitness for people with varying levels of mobility disability. The intervention is delivered remotely via videoconferencing due to COVID-19 precautions.

How Is the Trial Designed?

Group I: eM2M Experimental Treatment 1 Intervention

Participants in the eM2M arm will participate in an intervention that involves three 60-minute M2M sessions per week for 12 weeks. All sessions are delivered remotely in real-time through videoconferencing technology. At the beginning and end of each session, vital signs (heart rate, blood pressure and peripheral capillary oxygen saturation) are obtained from participants. Participants rate perceived exertion, pain, and fatigue level on a log. Participants set weekly exercise goals and expectations at first session of each week. Participants also record daily activities using a provided log.

Group II: Waitlist Control Active Control 1 Intervention

Participants in the waitlist control arm are instructed to maintain their usual activities during the 12-week intervention period and are asked to record their activities on a provided log.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Lakeshore Foundation

Collaborator

Trials

10

Recruited

1,900+

YMCA of Greater Birmingham

Collaborator

Trials

1

Recruited

110+

Citations

1. England pubmed.ncbi.nlm.nih.gov

The movement-to-music (M2M) study: study protocol for a randomized controlled efficacy trial examining a rhythmic teleexercise intervention for people with physical disabilities. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Which impairments are most associated with high mobility performance in older adults? Implications for a rehabilitation prescription. [2008]

3. United States pubmed.ncbi.nlm.nih.gov

Social Participation Modifies the Effect of a Structured Physical Activity Program on Major Mobility Disability Among Older Adults: Results From the LIFE Study. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Implementation of a Cost-Effective Physical Therapy Approach (Coach2Move) to Improve Physical Activity in Community-Dwelling Older Adults With Mobility Problems: Protocol for a Cluster-Randomized, Stepped Wedge Trial. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Ratings of Perceived Exertion During Walking: Predicting Major Mobility Disability and Effect of Structured Physical Activity in Mobility-Limited Older Adults. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The Effects of a Movement-to-Music (M2M) Intervention on Physical and Psychosocial Outcomes in People Poststroke: A Randomized Controlled Trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Rationale and design of a Scale-Up Project Evaluating Responsiveness to Home Exercise And Lifestyle Tele-Health (SUPER-HEALTH) in people with physical/mobility disabilities: a type 1 hybrid design effectiveness trial. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Exercise load and physical activity intensity in relation to dystonia and choreoathetosis during powered wheelchair mobility in children and youth with dyskinetic cerebral palsy. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Dance and rehabilitation in cerebral palsy: a systematic search and review. [2019]

10. England pubmed.ncbi.nlm.nih.gov

The effects of a movement with music program on measures of balance and gait speed in healthy older adults. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Rehabilitation, exercise therapy and music in patients with Parkinson's disease: a meta-analysis of the effects of music-based movement therapy on walking ability, balance and quality of life. [2022]