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CompletedNCT02533882LEADERSUpdated Oct 15, 2019

Lakeshore Examination of Activity and Disability Exercise Response Study

An interventional study of Movement to Music and Adapted Yoga in Multiple Sclerosis and Stroke, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-10-15.

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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). 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.

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Conditions studied

  • Multiple Sclerosis
  • Stroke
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In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 180 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • Current tobacco user or quit within the last six months
  • Current use of medications for psychosis
  • Active pressure ulcers
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
180 participants (actual)

Study arms

  • Experimental
    Movement to Music

    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.

    Behavioral: Movement to Music

  • Active comparator
    Adapted Yoga

    Yoga classes will consist of postures adapted by qualified yoga instructors who have extensive experience in disability.

    Behavioral: Adapted Yoga

  • No intervention
    Waitlist Control

    This group will receive biweekly newsletters on a variety of topics. At the end of this trial, they will receive a home based intervention.

Interventions

  • BehavioralMovement to Music
  • BehavioralAdapted Yoga
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What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 weeks

  2. Pain as measured by PROMIS Pain Interference Short Form 8a

    Time frame: 12 weeks

  3. Fatigue as measured by PROMIS Fatigue Short Form 8a

    Time frame: 12 weeks

  4. Loneliness as measured by the Three-Item Loneliness Scale

    Time frame: 12 weeks

  5. Grip Strength as measured by hand grip dynamometer

    Time frame: 12 weeks

  6. 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.

    Time frame: 12 weeks

  7. 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.

    Time frame: 12 weeks

  8. 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.

    Time frame: 12 weeks

  9. 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.

    Time frame: 12 weeks

Secondary outcomes

  1. Health Biomarkers as measured by blood analysis (insulin)

    Time frame: 12 weeks

  2. Health Biomarkers as measured by blood analysis (lipids)

    Time frame: 12 weeks

  3. Health Biomarkers as measured by blood analysis (fasting glucose)

    Time frame: 12 weeks

  4. Blood pressure

    Time frame: 12 weeks

  5. Anthropometric measurements (weight)

    Time frame: 12 weeks

  6. Circumference measurements to be reported as composite ratios (waist circumference, hip circumference, neck circumference)

    Time frame: 12 weeks

  7. Physical Function with Mobility Aid as measured by PROMIS Physical Function with Mobility Aid 455b

    Time frame: 12 weeks

  8. Anxiety as measured by PROMIS Emotional Distress-Anxiety Short Form 8a

    Time frame: 12 weeks

  9. Depression as measured by PROMIS Emotional Distress-Depression Short Form 8a

    Time frame: 12 weeks

  10. Sleep Disturbance as measured by PROMIS Sleep Disturbance Short Form 8a

    Time frame: 12 weeks

  11. 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

  12. Nutrition Self-Efficacy as measured by the Nutrition Self-Efficacy Scale

    Time frame: 12 weeks

  13. Physical Exercise Self-Efficacy as measured by the Physical Exercise Self Efficacy Scale

    Time frame: 12 weeks

  14. PROMIS Pain Intensity Short Form

    Time frame: 12 Weeks

07

Study locations

1 site
  • Lakeshore Foundation
    Birmingham, Alabama 35209, United States
08

References and documents

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 30092206 ↗
  • Rimmer 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02533882
Lead sponsor
University of Alabama at Birmingham
Collaborators
Lakeshore Foundation
Responsible party
James Rimmer (Principal Investigator, University of Alabama at Birmingham) — Principal investigator
First posted
Aug 27, 2015
Start date
Dec 2014
Primary completion
Jul 15, 2019
Completion
Aug 30, 2019
Last update
Oct 15, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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