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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01109602
First received: April 2, 2010
Last updated: April 16, 2014
Last verified: April 2014
  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

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • balance self-efficacy - measured with the Activities Balance Confidence Scale [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01109602

Locations
United States, Indiana
Richard L. Roudebush VA Medical Center
Indianapolis, Indiana, United States, 46202-2884
Sponsors and Collaborators
Investigators
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 16, 2014
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 July 29, 2014