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Completed

NCT Number: NCT02533882

Lakeshore Examination of Activity and Disability Exercise Response Study

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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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lakeshore Foundation

Birmingham, Alabama, 35209, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Movement to Music

Behavioral

Adapted Yoga

Behavioral

Primary outcomes

  1. 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

  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

    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.

  7. 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.

  8. 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.

  9. 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.

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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Lakeshore Foundation

Registry information

Official study title

Dose-Response Effects of Transformative Exercise in Improving Health and Function in Adults With Spinal Cord Injury and Multiple Sclerosis

Acronym: LEADERS

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Aug 27, 2015
Registry last updated
Oct 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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