Spinal Cord InjuriesM2M LEADERSNCT03797378
Movement-2-Music: Lakeshore Examination of Activity, Disability, and Exercise Response Study
A study testing eM2M in people with Spinal Cord Injuries and Traumatic Brain Injury, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries, Traumatic Brain Injury, Spina Bifida
- What is being tested?
- eM2M
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2019to 29 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UAB Research Collaborative
Birmingham, Alabama, 35209
About this study
Official title: The M2M LEADERS Project: Lakeshore Examination of Activity, Disability, and Exercise Response Study (LEADERS)
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.
Read the 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.
- Conditions
- Spinal Cord Injuries, Traumatic Brain Injury, Spina Bifida, Cerebral Palsy, Stroke, Parkinson Disease
- Being tested
- eM2M
- Medical subject headings
- Spinal Cord Injuries, Brain Injuries, Traumatic, Spinal Dysraphism, Cerebral Palsy, Stroke, Parkinson Disease, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eM2MOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline cardiorespiratory fitness at 3 months
The cardiorespiratory fitness is measured using a heart rate recovery test
Measured: 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.
Measured: Baseline and post 12-week intervention
Secondary outcomes (5)
Change from baseline lower extremity function at 3 months
Lower extremity function is assessed using the Short Physical Performance Battery (SPPB)
Measured: Baseline and post 12-week intervention
Change from baseline lower extremity function at 3 months
Lower extremity function will be assessed using the Timed Up and Go (TUG) test.
Measured: Baseline and post 12-week intervention
Change from baseline health-related quality of life at 3 months
Health-related quality of life is measured using the National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Items. The instrument is a 10-item measure with the response scores ranging from 1 (very severe) to 5 (none). Two summary scores, a global physical health score and a global mental health score, can be calculated from this scale, with each score ranging from 4 to 20. Higher scores indicate better health. The total raw score is translated into a T-score for each participant for analysis.
Measured: Baseline and post 12-week intervention
Change from baseline social participation at 3 months
Social participation is measured using the National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities. The instrument is a 8-item measure with the response scores ranging from 1 (always) to 5 (never). The lowest possible total raw score is 8 and the highest possible score is 40. Higher scores indicate better ability to participate in social roles and activities. The total raw score is translated into a T-score for each participant for analysis.
Measured: Baseline and post 12-week intervention
Change from baseline physical activity at 3 months
Physical activity is measured using the Godin Leisure Time Exercise Questionnaire. The questionnaire contains two questions. The first question asks participants to report weekly frequencies of activities they perform at different intensities. A total weekly leisure activity is a sum of activity scores calculated by multiplying the weekly frequencies of strenuous, moderate, and light activities by 9, 5, and 3, respectively. The second question asks participants the frequency of weekly leisure-time activities performed that are long enough to work up a sweat.
Measured: Baseline and post 12-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start9 Aug 2019
- Primary completion25 May 2023
- Study completion29 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Lakeshore Foundation, YMCA of Greater Birmingham, National Institute on Disability, Independent Living, and Rehabilitation Research
- Responsible party
- Principal investigator, James Rimmer, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03797378
- Sponsor's protocol ID
- IRB-300002645
- Other IDs
- 90DPGE0005
- Acronym
- M2M LEADERS
- Status last verified
- Sep 2025
- First submitted
- 13 Nov 2018
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 34743701
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The M2M LEADERS Project: Lakeshore Examination of Activity, Disability, and Exercise Response Study (LEADERS)
- ClinicalTrials.gov ID
- NCT03797378
- Acronym / sponsor ID
- M2M LEADERS / IRB-300002645
- Conditions
- Spinal Cord Injuries, Traumatic Brain Injury, Spina Bifida, Cerebral Palsy, Stroke, Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Lakeshore Foundation, YMCA of Greater Birmingham, National Institute on Disability, Independent Living, and Rehabilitation Research
- Study start
- 9 Aug 2019 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 29 Sep 2025 (actual)
- First posted
- 9 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eM2M | Experimental | Other: eM2MParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eM2MThe 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. | Other | eM2M |
Primary outcome
Change from baseline cardiorespiratory fitness at 3 months
Time frame: Baseline and post 12-week intervention
The cardiorespiratory fitness is measured using a heart rate recovery test
Change from baseline muscle strength at 3 months
Time frame: Baseline and post 12-week intervention
Muscle strength is measured with grip strength using a hand-held dynamometer.
5 secondary outcomes
Change from baseline lower extremity function at 3 months
Time frame: Baseline and post 12-week intervention
Change from baseline lower extremity function at 3 months
Time frame: Baseline and post 12-week intervention
Change from baseline health-related quality of life at 3 months
Time frame: Baseline and post 12-week intervention
Change from baseline social participation at 3 months
Time frame: Baseline and post 12-week intervention
Change from baseline physical activity at 3 months
Time frame: Baseline and post 12-week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Derived from this study: PubMed 34743701Young 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eM2M in people with Spinal Cord Injuries and Traumatic Brain Injury, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline cardiorespiratory fitness at 3 months (time frame: Baseline and post 12-week intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03797378, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.