Movement-2-Music: Lakeshore Examination of Activity, Disability, and Exercise Response Study

NCT03797378 | Completed

• 2 other identifiers: IRB-30000264590DPGE0005
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.\*\*

Conditions

Spinal Cord Injuries; Traumatic Brain Injury; Spina Bifida; Cerebral Palsy; Stroke; Parkinson Disease; Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• Change from baseline cardiorespiratory fitness at 3 months

  The cardiorespiratory fitness is measured using a heart rate recovery test

  Baseline and post 12-week intervention

• Change from baseline muscle strength at 3 months

  Muscle strength is measured with grip strength using a hand-held dynamometer.

  Baseline and post 12-week intervention

Secondary Outcomes (5)

• Change from baseline lower extremity function at 3 months

  Baseline and post 12-week intervention

• Change from baseline lower extremity function at 3 months

  Baseline and post 12-week intervention

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

  Baseline and post 12-week intervention

• Change from baseline social participation at 3 months

  Baseline and post 12-week intervention

• Change from baseline physical activity at 3 months

  Baseline and post 12-week intervention

Other Outcomes (5)

• Change from baseline barriers in physical activity at 3 months

  Baseline and post 12-week intervention

• Change from baseline exercise self-efficacy at 3 months

  Baseline and post 12-week intervention

• Change from baseline exercise goal-setting at 3 months

  Baseline and post 12-week intervention

Study Arms (2)

eM2M

EXPERIMENTAL

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.

Other: eM2M

Waitlist Control

NO 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.

Interventions

eM2M OTHER

The eM2M intervention involves three 60-minute sessions per week for 12 weeks. All sessions are delivered remotely in real-time through videoconferencing technology. The intervention uses combinations of movement patterns that target range of motion, muscle strength, cardiorespiratory fitness, balance, and breathing. Each session consists of movement routines choreographed to music, and every routine can be adapted to participants' functional ability.

eM2M

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Lakeshore Foundation: collaborator
• YMCA of Greater Birmingham: collaborator
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (1)

UAB Research Collaborative

Birmingham, Alabama, 35209, United States

Location

Related Publications (1)

• 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.

  PMID: 34743701 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Brain Injuries, Traumatic; Spinal Dysraphism; Cerebral Palsy; Stroke; Parkinson Disease; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Brain Injuries; Brain Diseases; Craniocerebral Trauma; Neural Tube Defects; Nervous System Malformations; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Brain Damage, Chronic; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lakeshore Foundation Endowed Chair in Health Promotion and Rehabilitation Sciences

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: January 9, 2019
• Study Start: August 9, 2019
• Primary Completion: May 25, 2023
• Study Completion: September 29, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (1)