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Lakeshore Examination of Activity and Disability Exercise Response Study

Not Applicable
Completed
Conditions
Stroke
Multiple Sclerosis
Interventions
Behavioral: Adapted Yoga
Behavioral: Movement to Music
Registration Number
NCT02533882
Lead Sponsor
University of Alabama at Birmingham
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
180
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
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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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Adapted YogaAdapted YogaYoga classes will consist of postures adapted by qualified yoga instructors who have extensive experience in disability.
Movement to MusicMovement 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.
Primary Outcome Measures
NameTimeMethod
Grip Strength as measured by hand grip dynamometer12 weeks
Cardiorespiratory Fitness as measured by sub-maximal VO212 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

Fatigue as measured by PROMIS Fatigue Short Form 8a12 weeks
Pain as measured by PROMIS Pain Interference Short Form 8a12 weeks
Loneliness as measured by the Three-Item Loneliness Scale12 weeks
Strength as measured by Biodex System 3 Multijoint dynamometer12 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 Repeated Chair Stands12 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.

Balance as measured by the Timed Up and Go12 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 Stability12 weeks

The Limits of Stability test is performed on the Biodex SD balance machine using the limits of stability protocol created by Biodex.

Secondary Outcome Measures
NameTimeMethod
Blood pressure12 weeks
Anxiety as measured by PROMIS Emotional Distress-Anxiety Short Form 8a12 weeks
Health Biomarkers as measured by blood analysis (insulin)12 weeks
Health Biomarkers as measured by blood analysis (lipids)12 weeks
Health Biomarkers as measured by blood analysis (fasting glucose)12 weeks
Anthropometric measurements (weight)12 weeks
Physical Function with Mobility Aid as measured by PROMIS Physical Function with Mobility Aid 455b12 weeks
Circumference measurements to be reported as composite ratios (waist circumference, hip circumference, neck circumference)12 weeks
Ability to participate in social roles and activities as measured by PROMIS Ability to Participate in Social Roles and Activities Short Form 8a12 weeks
Nutrition Self-Efficacy as measured by the Nutrition Self-Efficacy Scale12 weeks
Depression as measured by PROMIS Emotional Distress-Depression Short Form 8a12 weeks
Physical Exercise Self-Efficacy as measured by the Physical Exercise Self Efficacy Scale12 weeks
Sleep Disturbance as measured by PROMIS Sleep Disturbance Short Form 8a12 weeks
PROMIS Pain Intensity Short Form12 Weeks

Trial Locations

Locations (1)

Lakeshore Foundation

🇺🇸

Birmingham, Alabama, United States

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