Clinical trial NCT02533882: Lakeshore Examination of Activity and Disability Exercise Response Study
Official title: Dose-Response Effects of Transformative Exercise in Improving Health and Function in Adults With Spinal Cord Injury and Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Stroke
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Lakeshore Foundation
First posted: 2015-08-27
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Cardiorespiratory Fitness as measured by sub-maximal VO2
timeFrame: 12 weeks
measure: Pain as measured by PROMIS Pain Interference Short Form 8a
timeFrame: 12 weeks
measure: Fatigue as measured by PROMIS Fatigue Short Form 8a
timeFrame: 12 weeks
measure: Loneliness as measured by the Three-Item Loneliness Scale
timeFrame: 12 weeks
measure: Grip Strength as measured by hand grip dynamometer
timeFrame: 12 weeks
measure: Strength as measured by Biodex System 3 Multijoint dynamometer
timeFrame: 12 weeks
measure: Balance as measured by the Timed Up and Go
timeFrame: 12 weeks
measure: Balance as measured by Biodex Limits of Stability
timeFrame: 12 weeks
measure: Balance as measured by Repeated Chair Stands
timeFrame: 12 weeks
Secondary outcomes:
measure: Health Biomarkers as measured by blood analysis (insulin)
timeFrame: 12 weeks
measure: Health Biomarkers as measured by blood analysis (lipids)
timeFrame: 12 weeks
measure: Health Biomarkers as measured by blood analysis (fasting glucose)
timeFrame: 12 weeks
measure: Blood pressure
timeFrame: 12 weeks
measure: Anthropometric measurements (weight)
timeFrame: 12 weeks
measure: Circumference measurements to be reported as composite ratios (waist circumference, hip circumference, neck circumference)
timeFrame: 12 weeks
measure: Physical Function with Mobility Aid as measured by PROMIS Physical Function with Mobility Aid 455b
timeFrame: 12 weeks
measure: Anxiety as measured by PROMIS Emotional Distress-Anxiety Short Form 8a
timeFrame: 12 weeks
measure: Depression as measured by PROMIS Emotional Distress-Depression Short Form 8a
timeFrame: 12 weeks
measure: Sleep Disturbance as measured by PROMIS Sleep Disturbance Short Form 8a
timeFrame: 12 weeks
measure: Ability to participate in social roles and activities as measured by PROMIS Ability to Participate in Social Roles and Activities Short Form 8a
timeFrame: 12 weeks
measure: Nutrition Self-Efficacy as measured by the Nutrition Self-Efficacy Scale
timeFrame: 12 weeks
measure: Physical Exercise Self-Efficacy as measured by the Physical Exercise Self Efficacy Scale
timeFrame: 12 weeks
measure: PROMIS Pain Intensity Short Form
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Lakeshore Foundation
state: Alabama
Study officials:
References:
citation: Young HJ, Mehta TS, Herman C, Wang F, Rimmer JH. The Effects of M2M and Adapted Yoga on Physical and Psychosocial Outcomes in People With Multiple Sclerosis. Arch Phys Med Rehabil. 2019 Mar;100(3):391-400. doi: 10.1016/j.apmr.2018.06.032. Epub 2018 Aug 6.
citation: Rimmer JH, Herman C, Wingo B, Fontaine K, Mehta T. Methodological and clinical implications of a three-in-one Russian doll design for tracking health trajectories and improving health and function through innovative exercise treatments in adults with disability. BMC Med Res Methodol. 2018 Mar 14;18(1):28. doi: 10.1186/s12874-018-0480-3.