Movement-2-Music Exercise Program for Mobility Disabilities

(M2M LEADERS Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an exercise program called Movement-2-Music (M2M) to evaluate its impact on health and fitness in adults with mobility disabilities. Participants will either join the M2M group, engaging in remote, real-time music-based exercise sessions three times a week, or be placed in a waitlist control group. The study aims to understand how varying levels of mobility might influence the program's effectiveness. Individuals with conditions such as head injury, stroke, or multiple sclerosis, who can use their arms or legs to exercise, may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance exercise options for people with mobility challenges.

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.

What prior data suggests that the Movement-2-Music program is safe for individuals with mobility disabilities?

Research has shown that the Movement-2-Music (M2M) program is generally safe for people with mobility disabilities. Previous studies found that participants handled the program well, reporting better balance and coordination without major side effects. The program has been adapted for online use, making it more accessible while maintaining safety.

In past studies, participants tracked their heart rate, blood pressure, and oxygen levels during sessions. They also noted their exertion levels and any pain or tiredness. This careful monitoring ensures the exercises remain safe. Overall, the M2M program is a promising and well-tolerated way to improve health and fitness for people with disabilities. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Movement-2-Music (M2M) exercise program for mobility disabilities because it offers a unique and accessible approach to improving physical activity. Unlike traditional physical therapy or medication, the M2M program delivers sessions remotely through videoconferencing, making it more accessible for individuals who may face barriers to attending in-person sessions. Additionally, the program integrates music with movement, which can enhance motivation and enjoyment, potentially leading to better adherence and outcomes. This innovative method not only aims to improve mobility but also actively engages participants in setting personal goals and tracking their progress, fostering a more personalized and empowering experience.

What evidence suggests that the Movement-2-Music program is effective for improving health and fitness in adults with mobility disabilities?

Research has shown that the Movement-2-Music (M2M) program can enhance health and fitness for individuals with mobility disabilities. In earlier studies, participants experienced improved lower body movement and reduced fatigue after completing a 12-week M2M program. Specifically, those recovering from strokes demonstrated better physical and mental health. In this trial, participants in the eM2M arm will engage in exercise sessions with music, which helps maintain interest and motivation. Overall, these findings suggest that M2M could effectively boost mobility and overall health for those with physical disabilities. ^{1 2 6 7 8}

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+

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Trials

83

Recruited

10,500+

Lakeshore Foundation

Collaborator

Trials

10

Recruited

1,900+

YMCA of Greater Birmingham

Collaborator

Trials

1

Recruited

110+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03797378?cond=multiple+sclerosis&aggFilters=status%3A

Movement-2-Music: Lakeshore Examination of Activity, ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8683867/

The Effects of a Movement-to-Music (M2M) Intervention on ... Objective. To investigate the effects of a 12-week movement-to-music (M2M) intervention on physical and psychosocial outcomes in people poststroke.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8574035/

The movement-to-music (M2M) study The study is a two-arm randomized controlled efficacy trial examining a 12-week remotely delivered M2M intervention (eM2M) in 108 people with physical ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03797378/movement-2-music-lakeshore-examination-of-activity-disability-and-exercise-response-study?activelyRecruiting=false&page=779&id=42&slug=cerebral-ischemia

Lakeshore Examination of Activity, Disability, and Exercise ... 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 ...

5. researchgate.net researchgate.net/publication/354978386_Effects_of_a_Novel_Movement-to-Music_M2M_Intervention_on_Physical_and_Psychosocial_Outcomes_in_People_Poststroke_A_Randomized_Controlled_Trial

(PDF) Effects of a Novel Movement-to-Music (M2M ... The program originated from a clinical efficacy trial that demonstrated improvements in lower extremity function and fatigue among adults with mobility ...

6. withpower.com withpower.com/trial/phase-cerebral-palsy-7-2019-cfb46

Movement-2-Music Exercise Program for Mobility Disabilities ... 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 ...

7. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05751-2

The movement-to-music (M2M) study: study protocol for a ... The movement-to-music (M2M) study aims to examine a rhythmic-based teleexercise intervention (eM2M) with 108 adults with physical disabilities.

8. mdpi.com mdpi.com/2227-9067/12/1/87

The Impact of a Music- and Movement-Based Intervention ... Results: Statistical analysis showed that music and movement intervention significantly improved motor functions such as balance and bilateral coordination (p < ...