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

Primary Purpose

Multiple Sclerosis, Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Movement to Music
Adapted Yoga
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lakeshore Foundation

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Movement to Music

Adapted Yoga

Waitlist Control

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

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
Pain as measured by PROMIS Pain Interference Short Form 8a
Fatigue as measured by PROMIS Fatigue Short Form 8a
Loneliness as measured by the Three-Item Loneliness Scale
Grip Strength as measured by hand grip dynamometer
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.
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.
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.
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.

Secondary Outcome Measures

Health Biomarkers as measured by blood analysis (insulin)
Health Biomarkers as measured by blood analysis (lipids)
Health Biomarkers as measured by blood analysis (fasting glucose)
Blood pressure
Anthropometric measurements (weight)
Circumference measurements to be reported as composite ratios (waist circumference, hip circumference, neck circumference)
Physical Function with Mobility Aid as measured by PROMIS Physical Function with Mobility Aid 455b
Anxiety as measured by PROMIS Emotional Distress-Anxiety Short Form 8a
Depression as measured by PROMIS Emotional Distress-Depression Short Form 8a
Sleep Disturbance as measured by PROMIS Sleep Disturbance Short Form 8a
Ability to participate in social roles and activities as measured by PROMIS Ability to Participate in Social Roles and Activities Short Form 8a
Nutrition Self-Efficacy as measured by the Nutrition Self-Efficacy Scale
Physical Exercise Self-Efficacy as measured by the Physical Exercise Self Efficacy Scale
PROMIS Pain Intensity Short Form

Full Information

First Posted
March 6, 2015
Last Updated
October 14, 2019
Sponsor
University of Alabama at Birmingham
Collaborators
Lakeshore Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02533882
Brief Title
Lakeshore Examination of Activity and Disability Exercise Response Study
Acronym
LEADERS
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

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
July 15, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Lakeshore Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Stroke

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Movement to Music
Arm Type
Experimental
Arm Description
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.
Arm Title
Adapted Yoga
Arm Type
Active Comparator
Arm Description
Yoga classes will consist of postures adapted by qualified yoga instructors who have extensive experience in disability.
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
This group will receive biweekly newsletters on a variety of topics. At the end of this trial, they will receive a home based intervention.
Intervention Type
Behavioral
Intervention Name(s)
Movement to Music
Intervention Type
Behavioral
Intervention Name(s)
Adapted Yoga
Primary Outcome Measure Information:
Title
Cardiorespiratory Fitness as measured by sub-maximal VO2
Description
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
Time Frame
12 weeks
Title
Pain as measured by PROMIS Pain Interference Short Form 8a
Time Frame
12 weeks
Title
Fatigue as measured by PROMIS Fatigue Short Form 8a
Time Frame
12 weeks
Title
Loneliness as measured by the Three-Item Loneliness Scale
Time Frame
12 weeks
Title
Grip Strength as measured by hand grip dynamometer
Time Frame
12 weeks
Title
Strength as measured by Biodex System 3 Multijoint dynamometer
Description
Upper body strength is measured using a closed chain push/pull protocol. Lower body strength is measured using the knee flexion/extension protocol.
Time Frame
12 weeks
Title
Balance as measured by the Timed Up and Go
Description
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.
Time Frame
12 weeks
Title
Balance as measured by Biodex Limits of Stability
Description
The Limits of Stability test is performed on the Biodex SD balance machine using the limits of stability protocol created by Biodex.
Time Frame
12 weeks
Title
Balance as measured by Repeated Chair Stands
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Health Biomarkers as measured by blood analysis (insulin)
Time Frame
12 weeks
Title
Health Biomarkers as measured by blood analysis (lipids)
Time Frame
12 weeks
Title
Health Biomarkers as measured by blood analysis (fasting glucose)
Time Frame
12 weeks
Title
Blood pressure
Time Frame
12 weeks
Title
Anthropometric measurements (weight)
Time Frame
12 weeks
Title
Circumference measurements to be reported as composite ratios (waist circumference, hip circumference, neck circumference)
Time Frame
12 weeks
Title
Physical Function with Mobility Aid as measured by PROMIS Physical Function with Mobility Aid 455b
Time Frame
12 weeks
Title
Anxiety as measured by PROMIS Emotional Distress-Anxiety Short Form 8a
Time Frame
12 weeks
Title
Depression as measured by PROMIS Emotional Distress-Depression Short Form 8a
Time Frame
12 weeks
Title
Sleep Disturbance as measured by PROMIS Sleep Disturbance Short Form 8a
Time Frame
12 weeks
Title
Ability to participate in social roles and activities as measured by PROMIS Ability to Participate in Social Roles and Activities Short Form 8a
Time Frame
12 weeks
Title
Nutrition Self-Efficacy as measured by the Nutrition Self-Efficacy Scale
Time Frame
12 weeks
Title
Physical Exercise Self-Efficacy as measured by the Physical Exercise Self Efficacy Scale
Time Frame
12 weeks
Title
PROMIS Pain Intensity Short Form
Time Frame
12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Lakeshore Foundation
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30092206
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.
Results Reference
derived
PubMed Identifier
29540164
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.
Results Reference
derived

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Lakeshore Examination of Activity and Disability Exercise Response Study

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