Lakeshore Examination of Activity and Disability Exercise Response Study

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.

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

Conditions
-----------------
Multiple Sclerosis, Stroke

Intervention / Treatment
-----------------
* Behavioral: Movement to Music
* Behavioral: Adapted Yoga


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Movement to Music<br>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. | Behavioral: Movement to Music<br> <br> |
| Active Comparator: Adapted Yoga<br>Yoga classes will consist of postures adapted by qualified yoga instructors who have extensive experience in disability. | Behavioral: Adapted Yoga<br> <br> |
| No Intervention: Waitlist Control<br>This group will receive biweekly newsletters on a variety of topics. At the end of this trial, they will receive a home based intervention. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiorespiratory Fitness as measured by sub-maximal VO2 | 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 | 12 weeks | 
| Pain as measured by PROMIS Pain Interference Short Form 8a |  | 12 weeks | 
| Fatigue as measured by PROMIS Fatigue Short Form 8a |  | 12 weeks | 
| Loneliness as measured by the Three-Item Loneliness Scale |  | 12 weeks | 
| Grip Strength as measured by hand grip dynamometer |  | 12 weeks | 
| Strength as measured by Biodex System 3 Multijoint dynamometer | Upper body strength is measured using a closed chain push/pull protocol. Lower body strength is measured using the knee flexion/extension protocol. | 12 weeks | 
| Balance as measured by the Timed Up and Go | 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. | 12 weeks | 
| Balance as measured by Biodex Limits of Stability | The Limits of Stability test is performed on the Biodex SD balance machine using the limits of stability protocol created by Biodex. | 12 weeks | 
| Balance as measured by Repeated Chair Stands | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Blood pressure |  | 12 weeks | 
| Anthropometric measurements (weight) |  | 12 weeks | 
| Circumference measurements to be reported as composite ratios (waist circumference, hip circumference, neck circumference) |  | 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 | 
| 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 | 
| 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 | 
| PROMIS Pain Intensity Short Form |  | 12 Weeks |