Dose-Response Effects of Transformative Exercise in Improving Health and Function in Adults With Spinal Cord Injury and Multiple Sclerosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- University of Alabama at Birmingham
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Grip Strength as measured by hand grip dynamometer
- Status
- Completed
- Last Updated
- 6 years ago
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.
Investigators
James Rimmer
Principal Investigator
University of Alabama at Birmingham
Eligibility Criteria
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
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
- Blood pressure(12 weeks)
- Anthropometric measurements (weight)(12 weeks)
- Depression as measured by PROMIS Emotional Distress-Depression 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)
- 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)
- PROMIS Pain Intensity Short Form(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)
- 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)