Trial Outcomes & Findings for Strength, Flexibility, And Balance Therapy After Stroke (NCT NCT01109602)
NCT ID: NCT01109602
Last Updated: 2015-11-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
47 participants
Primary outcome timeframe
2 months
Results posted on
2015-11-23
Participant Flow
Yoga and yoga plus groups were combined for analysis of data for Outcome Measures
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
23
|
10
|
|
Overall Study
COMPLETED
|
13
|
21
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Strength, Flexibility, And Balance Therapy After Stroke
Baseline characteristics by cohort
| Measure |
Arm 1: Yoga Group
n=14 Participants
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.
|
Arm 2: Yoga Group Plus
n=23 Participants
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.
|
Arm 3: Wait List Control Group
n=10 Participants
wait-list control: will be assessed before and after 8 weeks. Will then be offered the 8 week yoga intervention.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
68.33 years
STANDARD_DEVIATION 8.117 • n=5 Participants
|
62.35 years
STANDARD_DEVIATION 8.526 • n=7 Participants
|
60.2 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
64.1 years
STANDARD_DEVIATION 8.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
23 participants
n=7 Participants
|
10 participants
n=5 Participants
|
47 participants
n=4 Participants
|
|
months since stroke
|
49.25 months
STANDARD_DEVIATION 44.55 • n=5 Participants
|
59.13 months
STANDARD_DEVIATION 43.81 • n=7 Participants
|
36.4 months
STANDARD_DEVIATION 23.6 • n=5 Participants
|
51 months
STANDARD_DEVIATION 40.4 • n=4 Participants
|
|
type of stroke
ischemic
|
6 participants
n=5 Participants
|
20 participants
n=7 Participants
|
5 participants
n=5 Participants
|
31 participants
n=4 Participants
|
|
type of stroke
not ischemic
|
8 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
16 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 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.
Outcome measures
| Measure |
Yoga/Yoga Plus
n=37 Participants
Data for both yoga groups were combined for analyses. All participants received 8 weeks of group yoga twice a week. Participants randomized to 'yoga plus' also received an audio recording for meditation/relaxation. there were no differences between groups, thus the data were combined.
|
Wait List Control Group
n=10 Participants
Participants randomized to the Wait list control group were assessed and then waited for 8 weeks for no additional intervention, just usual care. they were then assessed again 8 weeks later.
|
|---|---|---|
|
Balance - Measured With the Berg Balance Scale
|
46.3 units on a scale
Standard Deviation 9.1
|
43.8 units on a scale
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: 2 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%).
Outcome measures
| Measure |
Yoga/Yoga Plus
n=37 Participants
Data for both yoga groups were combined for analyses. All participants received 8 weeks of group yoga twice a week. Participants randomized to 'yoga plus' also received an audio recording for meditation/relaxation. there were no differences between groups, thus the data were combined.
|
Wait List Control Group
n=10 Participants
Participants randomized to the Wait list control group were assessed and then waited for 8 weeks for no additional intervention, just usual care. they were then assessed again 8 weeks later.
|
|---|---|---|
|
Balance Self-efficacy - Measured With the Activities Balance Confidence Scale
|
66.8 units on a scale
Standard Deviation 23.4
|
56.2 units on a scale
Standard Deviation 25.8
|
SECONDARY outcome
Timeframe: 2 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.
Outcome measures
| Measure |
Yoga/Yoga Plus
n=37 Participants
Data for both yoga groups were combined for analyses. All participants received 8 weeks of group yoga twice a week. Participants randomized to 'yoga plus' also received an audio recording for meditation/relaxation. there were no differences between groups, thus the data were combined.
|
Wait List Control Group
n=10 Participants
Participants randomized to the Wait list control group were assessed and then waited for 8 weeks for no additional intervention, just usual care. they were then assessed again 8 weeks later.
|
|---|---|---|
|
Quality of Life - Measured With the Stroke Specific Quality of Life
|
35.8 units on a scale
Standard Deviation 9.1
|
33.0 units on a scale
Standard Deviation 6.2
|
Adverse Events
Arm 1: Yoga Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm 2: Yoga Group Plus
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 3: Wait List Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: Yoga Group
n=14 participants at risk
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.
|
Arm 2: Yoga Group Plus
n=23 participants at risk
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.
|
Arm 3: Wait List Control Group
n=10 participants at risk
wait-list control: will be assessed before and after 8 weeks. Will then be offered the 8 week yoga intervention.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
fall
|
0.00%
0/14 • 2 month period of the intervention
|
0.00%
0/23 • 2 month period of the intervention
|
0.00%
0/10 • 2 month period of the intervention
|
Other adverse events
| Measure |
Arm 1: Yoga Group
n=14 participants at risk
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.
|
Arm 2: Yoga Group Plus
n=23 participants at risk
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.
|
Arm 3: Wait List Control Group
n=10 participants at risk
wait-list control: will be assessed before and after 8 weeks. Will then be offered the 8 week yoga intervention.
|
|---|---|---|---|
|
Cardiac disorders
hospitalization
|
7.1%
1/14 • Number of events 1 • 2 month period of the intervention
|
0.00%
0/23 • 2 month period of the intervention
|
0.00%
0/10 • 2 month period of the intervention
|
Additional Information
Arlene Schmid, PhD, OTR
Colorado State University, Department of Occupational Therapy
Phone: 970-491-7562
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place