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Strength, Flexibility, And Balance Therapy After Stroke (HEALTHY)

Primary Purpose

Stroke

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Yoga focused on strength, flexibility, and balance
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, accidental falls, Yoga, Blood pressure, Range of Motion, Rehabilitation, Exercise, balance, quality of life, mobility

Eligibility Criteria

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

Inclusion Criteria:

  • veteran
  • in the Indianapolis, IN area
  • survived a stroke
  • on blood pressure medication
  • completed all rehabilitation
  • ability to stand with or without a device
  • able to speak and understand English
  • a score >4 out of 6 on the short mini mental status exam (MMSE)

Exclusion Criteria:

  • would not commit to the yoga intervention
  • self report of: serious cardiac conditions; history of serious chronic obstructive pulmonary disease or oxygen dependence; severe weight bearing pain; a history of significant psychiatric illness; uncontrollable diabetes with recent weight loss; and current enrollment in another research trial

Sites / Locations

  • Richard L. Roudebush VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Arm 1: Yoga Group

Arm 2: Yoga Group Plus

Arm 3: Wait list control group

Arm Description

Yoga Group, 8 week bi-weekly in-person yoga training focused on strength, flexibility, and balance Yoga focused on strength, flexibility, and balance

Yoga Group Plus: 8 week, bi-weekly in-person yoga training focused on strength, flexibility, and balance paired with almost daily at home yoga focused on breathing and relaxation. Yoga focused on strength, flexibility, and balance Data for both yoga groups were combined for analyses as there were not any differences between these two groups.

wait-list control: will be assessed before and after 8 weeks. Will then be offered the 8 week yoga intervention.

Outcomes

Primary Outcome Measures

Balance - Measured With the Berg Balance Scale
Balance was assessed with the Berg Balance Scale (BBS), a 14-item physical performance measure of static and dynamic balance found to be reliable and valid after stroke. Scoring ranges from 0-56, with higher scores indicating better balance. A score of <46 identifies an individual at risk for falls after stroke.

Secondary Outcome Measures

Balance Self-efficacy - Measured With the Activities Balance Confidence Scale
The 16 item Activities-specific Balance Confidence Scale (ABC) was used to measure balance self-efficacy. The ABC is a self-report of a participant's self-efficacy in maintaining static and dynamic balance control during functional tasks. The validity and reliability of the ABC have been previously demonstrated in individuals with stroke. Scoring is 'no confidence' (0%) to 'completely confident' (100%).
Quality of Life - Measured With the Stroke Specific Quality of Life
Quality of Life was measured using the validated 49 items of the Stroke Specific QoL scale (SSQoL). The SSQoL includes assessment of 12 domains: self-care; vision; language; mobility; work; upper extremity; thinking; personality; mood; family; social; and energy. Prior work indicates good psychometric properties. Higher scores indicate increased QoL. Range of scores is 13 to 65 for the total score.

Full Information

First Posted
April 2, 2010
Last Updated
November 4, 2015
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01109602
Brief Title
Strength, Flexibility, And Balance Therapy After Stroke
Acronym
HEALTHY
Official Title
Yoga as a Complex Intervention for Vets With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Approximately 780,000 people suffer a stroke annually in the United States; 200,000 are recurrent strokes. The 17,000 veterans who suffer a stroke yearly are at great risk for a second stroke and therefore should be targeted for stroke risk factor management and prevention interventions. Balance and fear of falling negatively impact activity and function. Decreased activity and blood pressure (BP) are important modifiable stroke risk factors. These can be addressed through a yoga exercise intervention. Yoga, like tai-chi, is old world alternative medicine that has the potential to greatly impact the lives of older adults.
Detailed Description
BACKGROUND: Approximately 780,000 people suffer a stroke annually in the United States; 200,000 are recurrent strokes. The 17,000 veterans who suffer a stroke yearly are at great risk for a second stroke and therefore should be targeted for stroke risk factor management and prevention interventions. Balance and fear of falling negatively impact activity and function. Decreased activity and blood pressure (BP) are important modifiable stroke risk factors. These can be addressed through a yoga exercise intervention. yoga, like tai-chi, is old world alternative medicine that has the potential to greatly impact the lives of older adults. OBJECTIVES: Our long term goal is to develop and test a yoga exercise intervention in a large VA trial for veterans who have survived a stroke. The objective of this pilot application was to obtain necessary information to support such a trial through the following specific aims: 1) determine the feasibility (including recruitment) of an 8 week yoga based intervention for veterans with stroke; 2) establish an appropriate dosing strategy for a post-stroke 8 week yoga exercise intervention for a future VA yoga implementation trial (Yoga Group, bi-weekly in-person vs Yoga Group Plus, bi-weekly in-person paired with almost daily at home yoga); and 3) estimate the effect size of yoga on variables of interest to determine the appropriate VA trial sample size. METHODS: We completed a mixed methods study to address the feasibility, dosing strategy, and estimation of effect size for the current pilot study. We recruited 45 people with stroke to participate in the Yoga Group or Yoga Group Plus; 15 participants were wait-listed to be used as a control. A registered yoga therapist (RYT) taught all classes. Qualitative data include semi-structured interviews after completion of the intervention regarding: perceived ability to do yoga exercise; satisfaction with the yoga intervention; satisfaction with the RYT; general health benefits for the intervention; and whether they would continue yoga practice. Quantitative data included compliance and recruitment information as well as multiple standardized assessments before and after the 8 week intervention including: blood pressure readings; fear of falling; balance; balance confidence; gait and mobility assessments; and quality of life. We compared those in yoga to those wait-listed and also completed within group analyses to determine change between baseline and 8 week scores.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, accidental falls, Yoga, Blood pressure, Range of Motion, Rehabilitation, Exercise, balance, quality of life, mobility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Yoga Group
Arm Type
Experimental
Arm Description
Yoga Group, 8 week bi-weekly in-person yoga training focused on strength, flexibility, and balance Yoga focused on strength, flexibility, and balance
Arm Title
Arm 2: Yoga Group Plus
Arm Type
Experimental
Arm Description
Yoga Group Plus: 8 week, bi-weekly in-person yoga training focused on strength, flexibility, and balance paired with almost daily at home yoga focused on breathing and relaxation. Yoga focused on strength, flexibility, and balance Data for both yoga groups were combined for analyses as there were not any differences between these two groups.
Arm Title
Arm 3: Wait list control group
Arm Type
No Intervention
Arm Description
wait-list control: will be assessed before and after 8 weeks. Will then be offered the 8 week yoga intervention.
Intervention Type
Other
Intervention Name(s)
Yoga focused on strength, flexibility, and balance
Other Intervention Name(s)
HEALTHY after stroke
Intervention Description
Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises.
Primary Outcome Measure Information:
Title
Balance - Measured With the Berg Balance Scale
Description
Balance was assessed with the Berg Balance Scale (BBS), a 14-item physical performance measure of static and dynamic balance found to be reliable and valid after stroke. Scoring ranges from 0-56, with higher scores indicating better balance. A score of <46 identifies an individual at risk for falls after stroke.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Balance Self-efficacy - Measured With the Activities Balance Confidence Scale
Description
The 16 item Activities-specific Balance Confidence Scale (ABC) was used to measure balance self-efficacy. The ABC is a self-report of a participant's self-efficacy in maintaining static and dynamic balance control during functional tasks. The validity and reliability of the ABC have been previously demonstrated in individuals with stroke. Scoring is 'no confidence' (0%) to 'completely confident' (100%).
Time Frame
2 months
Title
Quality of Life - Measured With the Stroke Specific Quality of Life
Description
Quality of Life was measured using the validated 49 items of the Stroke Specific QoL scale (SSQoL). The SSQoL includes assessment of 12 domains: self-care; vision; language; mobility; work; upper extremity; thinking; personality; mood; family; social; and energy. Prior work indicates good psychometric properties. Higher scores indicate increased QoL. Range of scores is 13 to 65 for the total score.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: veteran in the Indianapolis, IN area survived a stroke on blood pressure medication completed all rehabilitation ability to stand with or without a device able to speak and understand English a score >4 out of 6 on the short mini mental status exam (MMSE) Exclusion Criteria: would not commit to the yoga intervention self report of: serious cardiac conditions; history of serious chronic obstructive pulmonary disease or oxygen dependence; severe weight bearing pain; a history of significant psychiatric illness; uncontrollable diabetes with recent weight loss; and current enrollment in another research trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arlene A. Schmid, PhD OTR MS
Organizational Affiliation
Richard Roudebush VA Medical Center, Indianapolis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Richard L. Roudebush VA Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-2884
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22836351
Citation
Schmid AA, Van Puymbroeck M, Altenburger PA, Schalk NL, Dierks TA, Miller KK, Damush TM, Bravata DM, Williams LS. Poststroke balance improves with yoga: a pilot study. Stroke. 2012 Sep;43(9):2402-7. doi: 10.1161/STROKEAHA.112.658211. Epub 2012 Jul 26.
Results Reference
result

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Strength, Flexibility, And Balance Therapy After Stroke

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