Strength, Flexibility, And Balance Therapy After Stroke

Study Overview
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Brief Summary
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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
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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.

Official Title
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Yoga as a Complex Intervention for Vets With Stroke

Conditions
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Stroke

Intervention / Treatment
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* Other: Yoga focused on strength, flexibility, and balance


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Yoga Group<br>Yoga Group, 8 week bi-weekly in-person yoga training focused on strength, flexibility, and balance Yoga focused on strength, flexibility, and balance | Other: Yoga focused on strength, flexibility, and balance<br>* 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.<br>* Other names: HEALTHY after stroke;|
| Experimental: Arm 2: Yoga Group Plus<br>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. | Other: Yoga focused on strength, flexibility, and balance<br>* 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.<br>* Other names: HEALTHY after stroke;|
| No Intervention: Arm 3: Wait list control group<br>wait-list control: will be assessed before and after 8 weeks. Will then be offered the 8 week yoga intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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%). | 2 months | 
| 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. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, accidental falls, Yoga, Blood pressure, Range of Motion, Rehabilitation, Exercise, balance, quality of life, mobility