Lakeshore Examination of Activity and Disability Exercise Response Study (LEADERS)

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

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 Overview

• Status: Completed
• Conditions: Stroke; Multiple Sclerosis
• Intervention / Treatment: Behavioral: Movement to Music; Behavioral: Adapted Yoga

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Lakeshore Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Movement to Music
Active Comparator: Adapted Yoga; Yoga classes will consist of postures adapted by qualified yoga instructors who have extensive experience in disability.	Behavioral: Adapted Yoga
No Intervention: 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.

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	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Lakeshore Foundation

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): July 15, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: March 6, 2015
• First Submitted That Met QC Criteria: August 24, 2015
• First Posted (Estimate): August 27, 2015

Study Record Updates

• Last Update Posted (Actual): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 14, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: F140821001