Multiple SclerosisLEADERSNCT02533882
Lakeshore Examination of Activity and Disability Exercise Response Study
A study testing Movement to Music and Adapted Yoga in people with Multiple Sclerosis and Stroke, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study will examine the effectiveness of two types of group exercise classes on the health and functional status in inactive adults age 18-65 with neurological conditions including Multiple Sclerosis, stroke, and spinal cord injury (SCI). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Stroke
- What is being tested?
- Movement to Music and Adapted Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 30 Aug 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with stroke
- MS - mild to moderate disability (Patient Determined Disease Steps Score 0-6)
- Able to use arms or arms/legs for exercise
- Ambulatory or use manual wheelchair
Who cannot join
- Cognitive impairment (Mini-Mental State Exam score < 24)
- Recent weight change (+/- 25 pounds in 1 year)
- Poorly controlled blood pressure
- Cardiovascular disease event within the past six months
- Severe pulmonary disease
- Renal failure
Show all 9Show fewer
- Current tobacco user or quit within the last six months
- Current use of medications for psychosis
- Active pressure ulcers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose-Response Effects of Transformative Exercise in Improving Health and Function in Adults With Spinal Cord Injury and Multiple Sclerosis
This study will examine the effectiveness of two types of group exercise classes on the health and functional status in inactive adults age 18-65 with neurological conditions including Multiple Sclerosis, stroke, and spinal cord injury (SCI). Participants will be randomly assigned to one of three groups; Movement to Music, Adapted Yoga, or a waitlist group who will complete a home-based exercise intervention of either Movement to Music or Adapted Yoga.
- Conditions
- Multiple Sclerosis, Stroke
- Being tested
- Movement to Music, Adapted Yoga
- Medical subject headings
- Multiple Sclerosis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Movement to MusicBehavioural
Adapted YogaBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Movement to Music | Experimental | The Movement to Music classes are composed of a set of exercises tailored to the specific needs and capabilities of each target group. The class will consist of and aerobic component and a strength component performed to varying music tempos. All movements will be choreographed by qualified dance instructors. Receives: Behavioral: Movement to Music |
| Adapted Yoga | Active comparator | Yoga classes will consist of postures adapted by qualified yoga instructors who have extensive experience in disability. Receives: Behavioral: Adapted Yoga |
| Waitlist Control | No intervention | This group will receive biweekly newsletters on a variety of topics. At the end of this trial, they will receive a home based intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory Fitness as measured by sub-maximal VO2
Submax VO2 is assessed by the six minute walk test or the six minute push test. Participants wear a portable metabolic cart while walking or pushing
Measured: 12 weeks
Pain as measured by PROMIS Pain Interference Short Form 8a
Measured: 12 weeks
Fatigue as measured by PROMIS Fatigue Short Form 8a
Measured: 12 weeks
Loneliness as measured by the Three-Item Loneliness Scale
Measured: 12 weeks
Grip Strength as measured by hand grip dynamometer
Measured: 12 weeks
Strength as measured by Biodex System 3 Multijoint dynamometer
Upper body strength is measured using a closed chain push/pull protocol. Lower body strength is measured using the knee flexion/extension protocol.
Measured: 12 weeks
Balance as measured by the Timed Up and Go
The Timed to Up and Go test is performed using a chair with arms. The participants stand up from the chair, walk to a mark measured three meters from the chair then return back to the seat. A score of greater than or equal to 14 seconds (average) has been shown to indicate a high risk of falling.
Measured: 12 weeks
Balance as measured by Biodex Limits of Stability
The Limits of Stability test is performed on the Biodex SD balance machine using the limits of stability protocol created by Biodex.
Measured: 12 weeks
Balance as measured by Repeated Chair Stands
The repeated chair stands test is performed by asking participants to stand up and sit down 5 times as fast as possible. A score of greater than or equal to 14 seconds (average) has been shown to indicate a high risk of falling.
Measured: 12 weeks
Secondary outcomes (14)
Health Biomarkers as measured by blood analysis (insulin)
Measured: 12 weeks
Health Biomarkers as measured by blood analysis (lipids)
Measured: 12 weeks
Health Biomarkers as measured by blood analysis (fasting glucose)
Measured: 12 weeks
Blood pressure
Measured: 12 weeks
Anthropometric measurements (weight)
Measured: 12 weeks
Circumference measurements to be reported as composite ratios (waist circumference, hip circumference, neck circumference)
Measured: 12 weeks
Physical Function with Mobility Aid as measured by PROMIS Physical Function with Mobility Aid 455b
Measured: 12 weeks
Anxiety as measured by PROMIS Emotional Distress-Anxiety Short Form 8a
Measured: 12 weeks
Depression as measured by PROMIS Emotional Distress-Depression Short Form 8a
Measured: 12 weeks
Sleep Disturbance as measured by PROMIS Sleep Disturbance Short Form 8a
Measured: 12 weeks
Ability to participate in social roles and activities as measured by PROMIS Ability to Participate in Social Roles and Activities Short Form 8a
Measured: 12 weeks
Nutrition Self-Efficacy as measured by the Nutrition Self-Efficacy Scale
Measured: 12 weeks
Physical Exercise Self-Efficacy as measured by the Physical Exercise Self Efficacy Scale
Measured: 12 weeks
PROMIS Pain Intensity Short Form
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study startDec 2014
- Primary completion15 Jul 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Lakeshore Foundation
- Responsible party
- Principal investigator, James Rimmer, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533882
- Sponsor's protocol ID
- F140821001
- Acronym
- LEADERS
- Status last verified
- Oct 2019
- First submitted
- 6 Mar 2015
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Young HJ, Mehta TS, Herman C, Wang F, Rimmer JH. The Effects of M2M and Adapted Yoga on Physical and Psychosocial Outcomes in People With Multiple Sclerosis. Arch Phys Med Rehabil. 2019 Mar;100(3):391-400. doi: 10.1016/j.apmr.2018.06.032. Epub 2018 Aug 6.
PubMed 30092206Rimmer JH, Herman C, Wingo B, Fontaine K, Mehta T. Methodological and clinical implications of a three-in-one Russian doll design for tracking health trajectories and improving health and function through innovative exercise treatments in adults with disability. BMC Med Res Methodol. 2018 Mar 14;18(1):28. doi: 10.1186/s12874-018-0480-3.
PubMed 29540164
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Response Effects of Transformative Exercise in Improving Health and Function in Adults With Spinal Cord Injury and Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02533882
- Acronym / sponsor ID
- LEADERS / F140821001
- Conditions
- Multiple Sclerosis, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Lakeshore Foundation
- Study start
- Dec 2014
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 27 Aug 2015 (estimated)
- 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.
This study will examine the effectiveness of two types of group exercise classes on the health and functional status in inactive adults age 18-65 with neurological conditions including Multiple Sclerosis, stroke, and spinal cord injury (SCI). Participants will be randomly assigned to one of three groups; Movement to Music, Adapted Yoga, or a waitlist group who will complete a home-based exercise intervention of either Movement to Music or Adapted Yoga.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Movement to Music | Experimental | Behavioral: Movement to MusicThe Movement to Music classes are composed of a set of exercises tailored to the specific needs and capabilities of each target group. The class will consist of and aerobic component and a strength component performed to varying music tempos. All movements will be choreographed by qualified dance instructors. |
| Adapted Yoga | Active comparator | Behavioral: Adapted YogaYoga classes will consist of postures adapted by qualified yoga instructors who have extensive experience in disability. |
| Waitlist Control | No intervention | –This group will receive biweekly newsletters on a variety of topics. At the end of this trial, they will receive a home based intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with stroke
- MS - mild to moderate disability (Patient Determined Disease Steps Score 0-6)
- Able to use arms or arms/legs for exercise
- Ambulatory or use manual wheelchair
Key exclusion criteria (9 listed)
- Cognitive impairment (Mini-Mental State Exam score < 24)
- Recent weight change (+/- 25 pounds in 1 year)
- Poorly controlled blood pressure
- Cardiovascular disease event within the past six months
- Severe pulmonary disease
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 |
|---|---|---|
| Movement to Music | Behavioural | Movement to Music |
| Adapted Yoga | Behavioural | Adapted Yoga |
Primary outcome
Cardiorespiratory Fitness as measured by sub-maximal VO2
Time frame: 12 weeks
Submax VO2 is assessed by the six minute walk test or the six minute push test. Participants wear a portable metabolic cart while walking or pushing
Pain as measured by PROMIS Pain Interference Short Form 8a
Time frame: 12 weeks
Fatigue as measured by PROMIS Fatigue Short Form 8a
Time frame: 12 weeks
Loneliness as measured by the Three-Item Loneliness Scale
Time frame: 12 weeks
Grip Strength as measured by hand grip dynamometer
Time frame: 12 weeks
Strength as measured by Biodex System 3 Multijoint dynamometer
Time frame: 12 weeks
Upper body strength is measured using a closed chain push/pull protocol. Lower body strength is measured using the knee flexion/extension protocol.
Balance as measured by the Timed Up and Go
Time frame: 12 weeks
The Timed to Up and Go test is performed using a chair with arms. The participants stand up from the chair, walk to a mark measured three meters from the chair then return back to the seat. A score of greater than or equal to 14 seconds (average) has been shown to indicate a high risk of falling.
Balance as measured by Biodex Limits of Stability
Time frame: 12 weeks
The Limits of Stability test is performed on the Biodex SD balance machine using the limits of stability protocol created by Biodex.
Balance as measured by Repeated Chair Stands
Time frame: 12 weeks
The repeated chair stands test is performed by asking participants to stand up and sit down 5 times as fast as possible. A score of greater than or equal to 14 seconds (average) has been shown to indicate a high risk of falling.
14 secondary outcomes
Health Biomarkers as measured by blood analysis (insulin)
Time frame: 12 weeks
Health Biomarkers as measured by blood analysis (lipids)
Time frame: 12 weeks
Health Biomarkers as measured by blood analysis (fasting glucose)
Time frame: 12 weeks
Blood pressure
Time frame: 12 weeks
Anthropometric measurements (weight)
Time frame: 12 weeks
Circumference measurements to be reported as composite ratios (waist circumference, hip circumference, neck circumference)
Time frame: 12 weeks
Physical Function with Mobility Aid as measured by PROMIS Physical Function with Mobility Aid 455b
Time frame: 12 weeks
Anxiety as measured by PROMIS Emotional Distress-Anxiety Short Form 8a
Time frame: 12 weeks
Depression as measured by PROMIS Emotional Distress-Depression Short Form 8a
Time frame: 12 weeks
Sleep Disturbance as measured by PROMIS Sleep Disturbance Short Form 8a
Time frame: 12 weeks
Ability to participate in social roles and activities as measured by PROMIS Ability to Participate in Social Roles and Activities Short Form 8a
Time frame: 12 weeks
Nutrition Self-Efficacy as measured by the Nutrition Self-Efficacy Scale
Time frame: 12 weeks
Physical Exercise Self-Efficacy as measured by the Physical Exercise Self Efficacy Scale
Time frame: 12 weeks
PROMIS Pain Intensity Short Form
Time frame: 12 Weeks
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 15 Oct 2019.
- Derived from this study: PubMed 30092206Young HJ, Mehta TS, Herman C, Wang F, Rimmer JH. The Effects of M2M and Adapted Yoga on Physical and Psychosocial Outcomes in People With Multiple Sclerosis. Arch Phys Med Rehabil. 2019 Mar;100(3):391-400. doi: 10.1016/j.apmr.2018.06.032. Epub 2018 Aug 6.
- Derived from this study: PubMed 29540164Rimmer JH, Herman C, Wingo B, Fontaine K, Mehta T. Methodological and clinical implications of a three-in-one Russian doll design for tracking health trajectories and improving health and function through innovative exercise treatments in adults with disability. BMC Med Res Methodol. 2018 Mar 14;18(1):28. doi: 10.1186/s12874-018-0480-3.
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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 Movement to Music and Adapted Yoga in people with Multiple Sclerosis and Stroke, 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 4 inclusion and 9 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 15 Oct 2019. 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?
Cardiorespiratory Fitness as measured by sub-maximal VO2 (time frame: 12 weeks). The study lists 9 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 NCT02533882, which also lists 2 linked publications.
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 15 Oct 2019; AzTrials last refreshed its copy on 2 Nov 2026.