DepressionNCT01806922
Yoga Exercise for Improving Balance in Patients With Subacute &Ｃhronic Stroke
A study testing Yoga in people with Depression and Stroke, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Hypothesis: This study investigated the hypothesis that subacute and chronic stroke patients who received a combination of yoga and traditional physiotherapy were getting more improvement in standing balance than traditional physiotherapy. And we also hypothesis yoga can improve post-stroke depression symtom. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Depression, Stroke
- What is being tested?
- Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2013to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The time of stroke onset is more than 91 days.
- Able to stand for more than 1 minutes.
- Between the ages of 30 and 80.
Who cannot join
- Now receive others palliative therapy.
- Significant psychotic disease.
- Obvious language disorder.
- Medical contraindication(clincans evaluate cannot included).
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital Hsin-Chu Branch
Hsinchu, 30059
About this study
Official title: Yoga Exercise for Improving Balance in Patients With Subacute &Ｃhronic Stroke : A Pilot Study
Hypothesis: This study investigated the hypothesis that subacute and chronic stroke patients who received a combination of yoga and traditional physiotherapy were getting more improvement in standing balance than traditional physiotherapy. And we also hypothesis yoga can improve post-stroke depression symtom.
- Conditions
- Depression, Stroke
- Being tested
- Yoga
- Keywords
- Yoga, Stroke, Standing balance, Depression
- Medical subject headings
- Depression, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Yoga training, Tradiational physiotherapy | Experimental | Experimental Group(20 people) receive tradiational physiotherapy(4 times in a week, every time 1 hour), and 8-weeks yoga training(2 time in a week, every time 1 hour) Receives: Behavioral: Yoga |
| Tradiational physiotherapy | No intervention | Control Group(20 people)only receive tradiational rehabiliation( 4 times in a week, every time 1 hour ) for 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
Measured: within 7 days after finish yoga therapy course
Secondary outcomes (1)
Taiwanese Depression Questionnaire
Measured: within 7 days after finish yoga therapy course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yen-Ting Lai, Principal investigator, National Taiwan University Hospital Hsin-Chu Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806922
- Sponsor's protocol ID
- 201210006RIB
- Status last verified
- Feb 2014
- First submitted
- 6 Mar 2013
- Last updated
- 11 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
1.Tyson SF, Hanley M, Chillala J, Selley A, Tallis RC. Balance disability after stroke. Phys Ther. 2006;86:30. 2.Jorgensen L, Engstad T, Jacobsen BK. Higher incidence of falls in long-term stroke survivors than in population controls: Depressive symptoms predict falls after stroke. Stroke. 2002;33:542-547 3.Balance retraining after stroke using force platform biofeedback. Phys Ther. 1997 ; 77;553-58. 4.A yoga-based exercise program for people with chronic poststroke hemiparesis. Bastille JV, Gill-Body KM. Phys Ther. 2004 Jan;84(1):33-48. 5.Poststroke balance improves with yoga: a pilot study.Schmid AA, Van Puymbroeck M, Altenburger PA, Schalk NL, Dierks TA, Miller KK, Damush TM, Bravata DM, Williams LS. Stroke. 2012 Sep;43(9):2402-7. Epub 2012 Jul 26. 6.Chan W, Immink MA, Hillier S. Yoga and exercise for symptoms of depression and anxiety in people with poststroke disability: a randomized, controlled pilot trial. Altern Ther Health Med. 2012 May-Jun;18(3):34-43.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga Exercise for Improving Balance in Patients With Subacute &Ｃhronic Stroke : A Pilot Study
- ClinicalTrials.gov ID
- NCT01806922
- Acronym / sponsor ID
- 201210006RIB
- Conditions
- Depression, Stroke
- Keywords
- Yoga, Stroke, Standing balance, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 7 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis: This study investigated the hypothesis that subacute and chronic stroke patients who received a combination of yoga and traditional physiotherapy were getting more improvement in standing balance than traditional physiotherapy. And we also hypothesis yoga can improve post-stroke depression symtom.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga training, Tradiational physiotherapy | Experimental | Behavioral: YogaExperimental Group(20 people) receive tradiational physiotherapy(4 times in a week, every time 1 hour), and 8-weeks yoga training(2 time in a week, every time 1 hour) |
| Tradiational physiotherapy | No intervention | –Control Group(20 people)only receive tradiational rehabiliation( 4 times in a week, every time 1 hour ) for 8 weeks. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The time of stroke onset is more than 91 days.
- Able to stand for more than 1 minutes.
- Between the ages of 30 and 80.
Key exclusion criteria (4 listed)
- Now receive others palliative therapy.
- Significant psychotic disease.
- Obvious language disorder.
- Medical contraindication(clincans evaluate cannot included).
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 | Behavioural | Yoga training, Tradiational physiotherapy |
Primary outcome
Berg Balance Scale
Time frame: within 7 days after finish yoga therapy course
1 secondary outcome
Taiwanese Depression Questionnaire
Time frame: within 7 days after finish yoga therapy course
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2014.
- Background1.Tyson SF, Hanley M, Chillala J, Selley A, Tallis RC. Balance disability after stroke. Phys Ther. 2006;86:30. 2.Jorgensen L, Engstad T, Jacobsen BK. Higher incidence of falls in long-term stroke survivors than in population controls: Depressive symptoms predict falls after stroke. Stroke. 2002;33:542-547 3.Balance retraining after stroke using force platform biofeedback. Phys Ther. 1997 ; 77;553-58. 4.A yoga-based exercise program for people with chronic poststroke hemiparesis. Bastille JV, Gill-Body KM. Phys Ther. 2004 Jan;84(1):33-48. 5.Poststroke balance improves with yoga: a pilot study.Schmid AA, Van Puymbroeck M, Altenburger PA, Schalk NL, Dierks TA, Miller KK, Damush TM, Bravata DM, Williams LS. Stroke. 2012 Sep;43(9):2402-7. Epub 2012 Jul 26. 6.Chan W, Immink MA, Hillier S. Yoga and exercise for symptoms of depression and anxiety in people with poststroke disability: a randomized, controlled pilot trial. Altern Ther Health Med. 2012 May-Jun;18(3):34-43.
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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.
Yen-Ting Lai principal investigator
National Taiwan University Hospital Hsin-Chu Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Depression and Stroke, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 4 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 11 Feb 2014. 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 Taiwan. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Berg Balance Scale (time frame: within 7 days after finish yoga therapy course). 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 NCT01806922, 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 11 Feb 2014.