Strength, Flexibility, And Balance Therapy After Stroke (HEALTHY)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Stroke |
Other: Yoga intervention focused on strength, flexibility, and balance therapy |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Yoga as a Complex Intervention for Vets With Stroke |
- balance self-efficacy - measured with the Activities Balance Confidence Scale [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- Blood pressure [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- Balance - measured with the Berg Balance Scale [ Time Frame: 2 months ] [ Designated as safety issue: No ]
- Quality of Life - measured with the Stroke specific Quality of Life [ Time Frame: 2 months ] [ Designated as safety issue: No ]
| Enrollment: | 45 |
| Study Start Date: | July 2010 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
Yoga Group, 8 week bi-weekly in-person yoga training focused on strength, flexibility, and balance
|
Other: Yoga intervention focused on strength, flexibility, and balance therapy
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.
Other Name: HEALTHY after stroke
|
|
Experimental: Arm 2
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. Data for both yoga groups were combined for analyses as there were not any diffences between these two groups.
|
Other: Yoga intervention focused on strength, flexibility, and balance therapy
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.
Other Name: HEALTHY after stroke
|
|
No Intervention: Arm 3
wait-list control: will be assessed before and after 8 weeks. Will then be offered the 8 week yoga intervention.
|
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-TIA 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Indiana | |
| Richard L. Roudebush VA Medical Center | |
| Indianapolis, Indiana, United States, 46202-2884 | |
| Principal Investigator: | Arlene A. Schmid, PhD OTR MS | Richard Roudebush VA Medical Center, Indianapolis |
More Information
Publications:
| Responsible Party: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT01109602 History of Changes |
| Other Study ID Numbers: | RRP 09-195 |
| Study First Received: | April 2, 2010 |
| Last Updated: | April 18, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Department of Veterans Affairs:
|
Stroke accidental falls Yoga Blood pressure Range of Motion |
Rehabilitation Exercise balance quality of life mobility |
Additional relevant MeSH terms:
|
Stroke Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 19, 2013