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Movement-2-Music Exercise Program for Mobility Disabilities (M2M LEADERS Trial)

N/A

Waitlist Available

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Primary diagnosis of head injury, stroke, multiple sclerosis, spinal cord injury, spina bifida, Parkinson disease, cerebral palsy by a physician

Be older than 18 years old

Must not have

Visual acuity that prevents following a group exercise class

Presence of active pressure ulcer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and post 12-week intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the effects of an innovative exercise program, movement-2-music (M2M), on health and fitness outcomes in adults with physical/mobility disabilities. One hundred and eight participants will be recruited and randomly enrolled into one of two groups: M2M or waitlist control. The primary aim of this study is to determine the effects of the 12-week M2M program on health and fitness in participants with physical/mobility disabilities. The study will also compare the observed effects of the program to a previous M2M study, and test whether adherence (attendance to the 12-week program) affects the

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since M2M involves physical activity through an exercise program set to music, potential side effects may include typical exercise-related issues such as muscle soreness or strain. However specific risks aren't detailed here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a neurological condition by a doctor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have an active pressure ulcer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and post 12-week intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and post 12-week intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and post 12-week intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline cardiorespiratory fitness at 3 months

Change from baseline muscle strength at 3 months

Secondary study objectives

Change from baseline health-related quality of life at 3 months

Change from baseline lower extremity function at 3 months

Change from baseline physical activity at 3 months

+1 more

Other study objectives

Change from baseline barriers in physical activity at 3 months

Change from baseline exercise goal-setting at 3 months

Change from baseline exercise self-efficacy at 3 months

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: eM2MExperimental Treatment1 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 ControlActive Control1 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.

0 / 3Eligibility criteria met