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

VA Office of Research and Development

Status and phase: Completed; Phase 2; Phase 1

Conditions: Stroke

Treatments: Other: Yoga focused on strength, flexibility, and balance

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01109602

RRP 09-195

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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47 participants in 3 patient groups

Arm 1: Yoga Group

Experimental group

Description:

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

Treatment:

Other: Yoga focused on strength, flexibility, and balance

Arm 2: Yoga Group Plus

Experimental group

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.

Treatment:

Other: Yoga focused on strength, flexibility, and balance

Arm 3: Wait list control group

No Intervention group

Description:

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