Lakeshore Examination of Activity and Disability Exercise Response Study

Stroke Clinical Trial

— LEADERS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02533882
• Other study ID #: F140821001
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: August 30, 2019

Study information

• Verified date: October 2019
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: August 30, 2019
• Est. primary completion date: July 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis
• Stroke

Intervention

Behavioral:
• Movement to Music

• Adapted Yoga

Locations

Country	Name	City	State
United States	Lakeshore Foundation	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Lakeshore Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Pain as measured by PROMIS Pain Interference Short Form 8a		12 weeks
Primary	Fatigue as measured by PROMIS Fatigue Short Form 8a		12 weeks
Primary	Loneliness as measured by the Three-Item Loneliness Scale		12 weeks
Primary	Grip Strength as measured by hand grip dynamometer		12 weeks
Primary	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
Primary	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
Primary	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
Primary	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	Health Biomarkers as measured by blood analysis (insulin)		12 weeks
Secondary	Health Biomarkers as measured by blood analysis (lipids)		12 weeks
Secondary	Health Biomarkers as measured by blood analysis (fasting glucose)		12 weeks
Secondary	Blood pressure		12 weeks
Secondary	Anthropometric measurements (weight)		12 weeks
Secondary	Circumference measurements to be reported as composite ratios (waist circumference, hip circumference, neck circumference)		12 weeks
Secondary	Physical Function with Mobility Aid as measured by PROMIS Physical Function with Mobility Aid 455b		12 weeks
Secondary	Anxiety as measured by PROMIS Emotional Distress-Anxiety Short Form 8a		12 weeks
Secondary	Depression as measured by PROMIS Emotional Distress-Depression Short Form 8a		12 weeks
Secondary	Sleep Disturbance as measured by PROMIS Sleep Disturbance Short Form 8a		12 weeks
Secondary	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
Secondary	Nutrition Self-Efficacy as measured by the Nutrition Self-Efficacy Scale		12 weeks
Secondary	Physical Exercise Self-Efficacy as measured by the Physical Exercise Self Efficacy Scale		12 weeks
Secondary	PROMIS Pain Intensity Short Form		12 Weeks