Lakeshore Examination of Activity and Disability Exercise Response Study
- Conditions
- StrokeMultiple Sclerosis
- Interventions
- Behavioral: Adapted YogaBehavioral: 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
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Adapted Yoga Adapted Yoga Yoga classes will consist of postures adapted by qualified yoga instructors who have extensive experience in disability. Movement to Music 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.
- Primary Outcome Measures
Name Time Method Grip Strength as measured by hand grip dynamometer 12 weeks Cardiorespiratory Fitness as measured by sub-maximal VO2 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
Fatigue as measured by PROMIS Fatigue Short Form 8a 12 weeks Pain as measured by PROMIS Pain Interference Short Form 8a 12 weeks Loneliness as measured by the Three-Item Loneliness Scale 12 weeks Strength as measured by Biodex System 3 Multijoint dynamometer 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 Repeated Chair Stands 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.
Balance as measured by the Timed Up and Go 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 12 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
Name Time Method Blood pressure 12 weeks Anxiety as measured by PROMIS Emotional Distress-Anxiety Short Form 8a 12 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 455b 12 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 8a 12 weeks Nutrition Self-Efficacy as measured by the Nutrition Self-Efficacy Scale 12 weeks Depression as measured by PROMIS Emotional Distress-Depression Short Form 8a 12 weeks Physical Exercise Self-Efficacy as measured by the Physical Exercise Self Efficacy Scale 12 weeks Sleep Disturbance as measured by PROMIS Sleep Disturbance Short Form 8a 12 weeks PROMIS Pain Intensity Short Form 12 Weeks
Trial Locations
- Locations (1)
Lakeshore Foundation
🇺🇸Birmingham, Alabama, United States