StrokeNCT02999464
Effect of Qigong on Balance, Fall Efficacy, Wellbeing of People With Stroke in Hong Kong
A study testing Qigong and Fitness exercise in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The purpose of this study is to compare the effects of qigong practice with fitness exercise on balance, fall-efficacy, physical functions, psychological wellbeing and quality of life of stroke survivors. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Qigong and Fitness exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteHong Kong
- Study dates
- Jul 2016to Jul 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of stroke and 3 months after the onset
- First episode of stroke or recurrent of stroke
- Able to stand for more than 15 minutes
- Able to take anterioposterior and lateral step without assistance or aid
- Medically stable
- Sufficient cognition to follow commands Abbreviated Mental Test (AMT) score ≥7
Who cannot join
- Vital signs unstable
- History or evidence of other neurological deficits other than stroke such as multiple sclerosis
- Severe primary diseases of the cardiovascular system, liver, kidney or hematopoietic system
- Experience in qigong practice
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Kowloon Hospital
Hong Kong, China
Shuk Man Yuen, 852-3129-7140, mandyyuensm@yahoo.com.hk
Tracy Chen, 852-3129-7140
About this study
Official title: Effect of Qigong on Balance, Fall Efficacy, Physical Functions and Psychological Wellbeing of People With Stroke in Hong Kong: A Randomized Controlled Trial
The purpose of this study is to compare the effects of qigong practice with fitness exercise on balance, fall-efficacy, physical functions, psychological wellbeing and quality of life of stroke survivors.
Read the detailed description
Participants: A total of 58 stroke survivors 3 months after the current stroke will be recruited.
Methodology: An assessor-blinded, randomized controlled trial will be conducted. Stroke survivors will be included in the study if they meet the inclusion criteria. Selected patients will be randomly allocated into either the experimental group or the control group. Participants allocated in the experimental group will receive qigong training while this qigong training will be replaced by a home fitness exercise in the control group. The experimental and control groups will be required to practice a total of 50 minutes of qigong and fitness training 3 times per week and for 16 weeks respectively. The main outcome measure is balance capacity with Mini-BESTest. The secondary outcomes are fall efficacy, number of falls, postural stability and control, depression, physical functions and quality of life. Assessments will be done at baseline, 8 weeks and 16 weeks follow-ups by blinded assessors.
Data analysis: The results will be analyzed using two-way repeated measures analysis of variance with Statistical Package for Social Science version 21.0. Alpha will be set at 0.05.
- Conditions
- Stroke
- Being tested
- Qigong, Fitness exercise
- Keywords
- stroke, qigong, randomized controlled trial, body-mind exercise, balance, quality of life, wellbeing
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QigongOther
Also called body-mind exercise
The experimental group will be required to practice a total of 50 minutes of qigong training 3 times per week and for 16 weeks
Fitness exerciseOther
Active control group will be required to practice a total of 50 minutes of fitness training 3 times per week and for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| Qigong | Experimental | Experimental group will receive a total of 50 minutes of qigong training 3 times per week and for 16 weeks. Receives: Other: Qigong |
| Fitness Exercise | Active comparator | Fitness exercise group will receive home fitness exercise 3 times per week and for 16 weeks. Receives: Other: Fitness exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-BESTest.
Change from baseline balance capacity at 8 weeks and 16 weeks
Measured: Baseline, 8th week and 16th week after intervention
Secondary outcomes (9)
Fall Efficacy Scale - International
Change from baseline fall efficacy of the subject at 8 weeks and 16 weeks
Measured: Baseline, 8th week and 16th week after intervention
Number of falls
Measured: Baseline, 8th week and 16th week after intervention
Limit of Stability by using Balance Master
Change from baseline postural stability at 8 weeks and 16 weeks
Measured: Baseline, 8th week and 16th week after intervention
Geriatric Depression Scale
Measured: Baseline, 8th week and 16th week after intervention
Five Times Sit to Stand Test
Lower extremity strength
Measured: Baseline, 8th week and 16th week after intervention
Timed Up and Go Test
Change from baseline gait speed at 8 weeks and 16 weeks
Measured: Baseline, 8th week and 16th week after intervention
Modified Barthel Index
Activities of daily living function
Measured: Baseline, 8th week and 16th week after intervention
Stroke-Specific Quality of Life Scale
Measured: Baseline, 8th week and 16th week after intervention
Sensory Organization Test by using Balance Master
Change from baseline postural control at 8 weeks and 16 weeks
Measured: Baseline, 8th week and 16th week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startJul 2016
- Primary completionJun 2017 (estimated)
- Study completionJul 2017 (estimated)
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 StrokeStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuen Shuk Man, The Hong Kong Polytechnic University
- Investigators
- Yiu-chung PANG, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999464
- Sponsor's protocol ID
- HSEARS20151013001
- Status last verified
- Jan 2017
- First submitted
- 24 Apr 2016
- Last updated
- 18 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Yuen M, Ouyang HX, Miller T, Pang MYC. Baduanjin Qigong Improves Balance, Leg Strength, and Mobility in Individuals With Chronic Stroke: A Randomized Controlled Study. Neurorehabil Neural Repair. 2021 May;35(5):444-456. doi: 10.1177/15459683211005020. Epub 2021 Apr 7.
PubMed 33825587
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Qigong on Balance, Fall Efficacy, Physical Functions and Psychological Wellbeing of People With Stroke in Hong Kong: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02999464
- Acronym / sponsor ID
- HSEARS20151013001
- Conditions
- Stroke
- Keywords
- stroke, qigong, randomized controlled trial, body-mind exercise, balance, quality of life, wellbeing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 21 Dec 2016 (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.
The purpose of this study is to compare the effects of qigong practice with fitness exercise on balance, fall-efficacy, physical functions, psychological wellbeing and quality of life of stroke survivors.
Detailed description
Participants: A total of 58 stroke survivors 3 months after the current stroke will be recruited.
Methodology: An assessor-blinded, randomized controlled trial will be conducted. Stroke survivors will be included in the study if they meet the inclusion criteria. Selected patients will be randomly allocated into either the experimental group or the control group. Participants allocated in the experimental group will receive qigong training while this qigong training will be replaced by a home fitness exercise in the control group. The experimental and control groups will be required to practice a total of 50 minutes of qigong and fitness training 3 times per week and for 16 weeks respectively. The main outcome measure is balance capacity with Mini-BESTest. The secondary outcomes are fall efficacy, number of falls, postural stability and control, depression, physical functions and quality of life. Assessments will be done at baseline, 8 weeks and 16 weeks follow-ups by blinded assessors.
Data analysis: The results will be analyzed using two-way repeated measures analysis of variance with Statistical Package for Social Science version 21.0. Alpha will be set at 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qigong | Experimental | Other: QigongExperimental group will receive a total of 50 minutes of qigong training 3 times per week and for 16 weeks. |
| Fitness Exercise | Active comparator | Other: Fitness exerciseFitness exercise group will receive home fitness exercise 3 times per week and for 16 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of stroke and 3 months after the onset
- First episode of stroke or recurrent of stroke
- Able to stand for more than 15 minutes
- Able to take anterioposterior and lateral step without assistance or aid
- Medically stable
Key exclusion criteria (4 listed)
- Vital signs unstable
- History or evidence of other neurological deficits other than stroke such as multiple sclerosis
- Severe primary diseases of the cardiovascular system, liver, kidney or hematopoietic system
- Experience in qigong practice
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 |
|---|---|---|
| QigongAlso: body-mind exerciseThe experimental group will be required to practice a total of 50 minutes of qigong training 3 times per week and for 16 weeks | Other | Qigong |
| Fitness exerciseActive control group will be required to practice a total of 50 minutes of fitness training 3 times per week and for 16 weeks | Other | Fitness Exercise |
Primary outcome
Mini-BESTest.
Time frame: Baseline, 8th week and 16th week after intervention
Change from baseline balance capacity at 8 weeks and 16 weeks
9 secondary outcomes
Fall Efficacy Scale - International
Time frame: Baseline, 8th week and 16th week after intervention
Number of falls
Time frame: Baseline, 8th week and 16th week after intervention
Limit of Stability by using Balance Master
Time frame: Baseline, 8th week and 16th week after intervention
Geriatric Depression Scale
Time frame: Baseline, 8th week and 16th week after intervention
Five Times Sit to Stand Test
Time frame: Baseline, 8th week and 16th week after intervention
Timed Up and Go Test
Time frame: Baseline, 8th week and 16th week after intervention
Modified Barthel Index
Time frame: Baseline, 8th week and 16th week after intervention
Stroke-Specific Quality of Life Scale
Time frame: Baseline, 8th week and 16th week after intervention
Sensory Organization Test by using Balance Master
Time frame: Baseline, 8th week and 16th week after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
- Derived from this study: PubMed 33825587Yuen M, Ouyang HX, Miller T, Pang MYC. Baduanjin Qigong Improves Balance, Leg Strength, and Mobility in Individuals With Chronic Stroke: A Randomized Controlled Study. Neurorehabil Neural Repair. 2021 May;35(5):444-456. doi: 10.1177/15459683211005020. Epub 2021 Apr 7.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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.
Yiu-chung PANG, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qigong and Fitness exercise in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 6 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: status not confirmed, as of the sponsor's last update on 18 Jan 2017. 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 Hong Kong. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuk-man YUEN, MPhil (852-9736-3529, mandyyuensm@yahoo.com.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-BESTest. (time frame: Baseline, 8th week and 16th week after intervention). 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 NCT02999464, 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 18 Jan 2017.