Dose-Response Effects of Transformative Exercise in Improving Health and Function in Adults With Spinal Cord Injury and Multiple Sclerosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Grip Strength as measured by hand grip dynamometer
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- 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
- •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
Arms & Interventions
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.
Intervention: Movement to Music (Behavioral)
Adapted Yoga
Yoga classes will consist of postures adapted by qualified yoga instructors who have extensive experience in disability.
Intervention: Adapted Yoga (Behavioral)
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.
Outcomes
Primary Outcomes
Grip Strength as measured by hand grip dynamometer
Time Frame: 12 weeks
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
Fatigue as measured by PROMIS Fatigue Short Form 8a
Time Frame: 12 weeks
Pain as measured by PROMIS Pain Interference Short Form 8a
Time Frame: 12 weeks
Loneliness as measured by the Three-Item Loneliness Scale
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 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.
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.
Secondary Outcomes
- Physical Exercise Self-Efficacy as measured by the Physical Exercise Self Efficacy Scale(12 weeks)
- Blood pressure(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)
- Anxiety as measured by PROMIS Emotional Distress-Anxiety Short Form 8a(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)
- Sleep Disturbance as measured by PROMIS Sleep Disturbance Short Form 8a(12 weeks)
- PROMIS Pain Intensity Short Form(12 Weeks)
Investigators
James Rimmer
Principal Investigator
University of Alabama at Birmingham