Lakeshore Examination of Activity and Disability Exercise Response Study

NCT02533882 | Completed

• 1 other identifier: F140821001
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Stroke

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (14)

• 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

Study Arms (3)

Movement to Music

EXPERIMENTAL

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

Adapted Yoga

ACTIVE COMPARATOR

Yoga classes will consist of postures adapted by qualified yoga instructors who have extensive experience in disability.

Behavioral: Adapted Yoga

Waitlist Control

NO INTERVENTION

This group will receive biweekly newsletters on a variety of topics. At the end of this trial, they will receive a home based intervention.

Interventions

Movement to Music BEHAVIORAL

Movement to Music

Adapted Yoga BEHAVIORAL

Adapted Yoga

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Lakeshore Foundation: collaborator

Study Sites (1)

Lakeshore Foundation

Birmingham, Alabama, 35209, United States

Location

Related Publications (2)

• 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.

  PMID: 30092206 DERIVED

• 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.

  PMID: 29540164 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Stroke

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2015
• First Posted: August 27, 2015
• Study Start: December 1, 2014
• Primary Completion: July 15, 2019
• Study Completion: August 30, 2019
• Last Updated: October 15, 2019

Record last verified: 2019-10

Locations

US (1)