Strength, Flexibility, And Balance Therapy After Stroke

NCT ID: NCT01109602

Last Updated: 2015-11-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2011-09-30

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1: Yoga Group

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

Yoga focused on strength, flexibility, and balance

Group Type: EXPERIMENTAL

Yoga focused on strength, flexibility, and balance

Intervention Type: OTHER

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.

Arm 2: Yoga Group Plus

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.

Group Type: EXPERIMENTAL

Yoga focused on strength, flexibility, and balance

Intervention Type: OTHER

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.

Arm 3: Wait list control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Yoga focused on strength, flexibility, and balance

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.

Intervention Type: OTHER

Other Intervention Names

HEALTHY after stroke

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arlene A. Schmid, PhD OTR MS

Role: PRINCIPAL_INVESTIGATOR

Richard Roudebush VA Medical Center, Indianapolis

Locations

Richard L. Roudebush VA Medical Center

Indianapolis, Indiana, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 22836351 (View on PubMed)

Other Identifiers

RRP 09-195

Identifier Type: -

Identifier Source: org_study_id