StrokePhase 1/2HEALTHYNCT01109602
Strength, Flexibility, And Balance Therapy After Stroke
A Phase 1/2 study testing Yoga focused on strength, flexibility, and balance in people with Stroke, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Yoga focused on strength, flexibility, and balance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Sep 2011
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Richard L. Roudebush VA Medical Center
Indianapolis, Indiana, 46202-2884
About this study
Official title: Yoga as a Complex Intervention for Vets With Stroke
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.
Read the 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
- Being tested
- Yoga focused on strength, flexibility, and balance
- Keywords
- Stroke, accidental falls, Yoga, Blood pressure, Range of Motion, Rehabilitation, Exercise, balance, quality of life, mobility
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga focused on strength, flexibility, and balanceOther
Also called HEALTHY after stroke
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Yoga Group | Experimental | Yoga Group, 8 week bi-weekly in-person yoga training focused on strength, flexibility, and balance
Yoga focused on strength, flexibility, and balance Receives: Other: Yoga focused on strength, flexibility, and balance |
| Arm 2: Yoga Group Plus | Experimental | 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. Receives: Other: Yoga focused on strength, flexibility, and balance |
| Arm 3: Wait list control group | No intervention | wait-list control: will be assessed before and after 8 weeks. Will then be offered the 8 week yoga intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Secondary outcomes (2)
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%).
Measured: 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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2010 (estimated)
- Study startJul 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Arlene A. Schmid, PhD OTR MS, Principal investigator, Richard Roudebush VA Medical Center, Indianapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01109602
- Sponsor's protocol ID
- RRP 09-195
- Acronym
- HEALTHY
- Status last verified
- Nov 2015
- First submitted
- 2 Apr 2010
- Last updated
- 23 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 22836351
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga as a Complex Intervention for Vets With Stroke
- ClinicalTrials.gov ID
- NCT01109602
- Acronym / sponsor ID
- HEALTHY / RRP 09-195
- Conditions
- Stroke
- Keywords
- Stroke, accidental falls, Yoga, Blood pressure, Range of Motion, Rehabilitation, Exercise, balance
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Jul 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 23 Apr 2010 (estimated)
- Results
- Posted 23 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Yoga Group | Experimental | Other: Yoga focused on strength, flexibility, and balanceYoga Group, 8 week bi-weekly in-person yoga training focused on strength, flexibility, and balance Yoga focused on strength, flexibility, and balance |
| Arm 2: Yoga Group Plus | Experimental | Other: Yoga focused on strength, flexibility, and balanceYoga 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. |
| Arm 3: Wait list control group | No intervention | –wait-list control: will be assessed before and after 8 weeks. Will then be offered the 8 week yoga intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- veteran
- in the Indianapolis, IN area
- survived a stroke
- on blood pressure medication
- completed all rehabilitation
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga focused on strength, flexibility, and balanceAlso: HEALTHY after strokeParticipants 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 | Arm 1: Yoga Group, Arm 2: Yoga Group Plus |
Primary outcome
Balance - Measured With the Berg Balance Scale
Time frame: 2 months
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 secondary outcomes
Balance Self-efficacy - Measured With the Activities Balance Confidence Scale
Time frame: 2 months
Quality of Life - Measured With the Stroke Specific Quality of Life
Time frame: 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22836351Schmid 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arlene A. Schmid, PhD OTR MS principal investigator
Richard Roudebush VA Medical Center, Indianapolis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Yoga focused on strength, flexibility, and balance in people with Stroke, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance - Measured With the Berg Balance Scale (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01109602, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2015.