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Strength, Flexibility, And Balance Therapy After Stroke

Yoga as a Complex Intervention for Vets With Stroke

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01109602
Acronym
HEALTHY
Enrollment
47
Registered
2010-04-23
Start date
2010-07-31
Completion date
2011-09-30
Last updated
2015-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke, accidental falls, Yoga, Blood pressure, Range of Motion, Rehabilitation, Exercise, balance, quality of life, mobility

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.

Interventions

OTHERYoga 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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Balance - Measured With the Berg Balance Scale2 monthsBalance 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.

Secondary

MeasureTime frameDescription
Balance Self-efficacy - Measured With the Activities Balance Confidence Scale2 monthsThe 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%).
Quality of Life - Measured With the Stroke Specific Quality of Life2 monthsQuality 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.

Countries

United States

Participant flow

Pre-assignment details

Yoga and yoga plus groups were combined for analysis of data for Outcome Measures

Participants by arm

ArmCount
Arm 1: Yoga Group
Yoga Group, 8 week bi-weekly in-person yoga training focused on strength, flexibility, and balance 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.
14
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. Data for both yoga groups were combined for analyses based off of data from the results. 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.
23
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.
10
Total47

Baseline characteristics

CharacteristicArm 2: Yoga Group PlusTotalArm 3: Wait List Control GroupArm 1: Yoga Group
Age, Continuous62.35 years
STANDARD_DEVIATION 8.526
64.1 years
STANDARD_DEVIATION 8.8
60.2 years
STANDARD_DEVIATION 8.9
68.33 years
STANDARD_DEVIATION 8.117
months since stroke59.13 months
STANDARD_DEVIATION 43.81
51 months
STANDARD_DEVIATION 40.4
36.4 months
STANDARD_DEVIATION 23.6
49.25 months
STANDARD_DEVIATION 44.55
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
8 Participants17 Participants4 Participants5 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants0 Participants0 Participants
Race (NIH/OMB)
White
14 Participants28 Participants6 Participants8 Participants
Region of Enrollment
United States
23 participants47 participants10 participants14 participants
Sex: Female, Male
Female
9 Participants9 Participants0 Participants0 Participants
Sex: Female, Male
Male
14 Participants38 Participants10 Participants14 Participants
type of stroke
ischemic
20 participants31 participants5 participants6 participants
type of stroke
not ischemic
3 participants16 participants5 participants8 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
1 / 140 / 230 / 10
serious
Total, serious adverse events
0 / 140 / 230 / 10

Outcome results

Primary

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.

Time frame: 2 months

ArmMeasureValue (MEAN)Dispersion
Yoga/Yoga PlusBalance - Measured With the Berg Balance Scale46.3 units on a scaleStandard Deviation 9.1
Wait List Control GroupBalance - Measured With the Berg Balance Scale43.8 units on a scaleStandard Deviation 6.3
Secondary

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%).

Time frame: 2 months

ArmMeasureValue (MEAN)Dispersion
Yoga/Yoga PlusBalance Self-efficacy - Measured With the Activities Balance Confidence Scale66.8 units on a scaleStandard Deviation 23.4
Wait List Control GroupBalance Self-efficacy - Measured With the Activities Balance Confidence Scale56.2 units on a scaleStandard Deviation 25.8
Secondary

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.

Time frame: 2 months

ArmMeasureValue (MEAN)Dispersion
Yoga/Yoga PlusQuality of Life - Measured With the Stroke Specific Quality of Life35.8 units on a scaleStandard Deviation 9.1
Wait List Control GroupQuality of Life - Measured With the Stroke Specific Quality of Life33.0 units on a scaleStandard Deviation 6.2

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026