Effect of Qigong on Balance, Fall Efficacy, Wellbeing of People With Stroke in Hong Kong

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Qigong on Balance, Fall Efficacy, Physical Functions and Psychological Wellbeing of People With Stroke in Hong Kong: A Randomized Controlled Trial

Conditions
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Stroke

Intervention / Treatment
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* Other: Qigong
* Other: Fitness exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Qigong<br>Experimental group will receive a total of 50 minutes of qigong training 3 times per week and for 16 weeks. | Other: Qigong<br>* The experimental group will be required to practice a total of 50 minutes of qigong training 3 times per week and for 16 weeks<br>* Other names: body-mind exercise;|
| Active Comparator: Fitness Exercise<br>Fitness exercise group will receive home fitness exercise 3 times per week and for 16 weeks. | Other: Fitness exercise<br>* Active control group will be required to practice a total of 50 minutes of fitness training 3 times per week and for 16 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini-BESTest. | Change from baseline balance capacity at 8 weeks and 16 weeks | Baseline, 8th week and 16th week after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fall Efficacy Scale - International | Change from baseline fall efficacy of the subject at 8 weeks and 16 weeks | Baseline, 8th week and 16th week after intervention | 
| Number of falls |  | 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 | Baseline, 8th week and 16th week after intervention | 
| Geriatric Depression Scale |  | Baseline, 8th week and 16th week after intervention | 
| Five Times Sit to Stand Test | Lower extremity strength | Baseline, 8th week and 16th week after intervention | 
| Timed Up and Go Test | Change from baseline gait speed at 8 weeks and 16 weeks | Baseline, 8th week and 16th week after intervention | 
| Modified Barthel Index | Activities of daily living function | Baseline, 8th week and 16th week after intervention | 
| Stroke-Specific Quality of Life Scale |  | 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 | Baseline, 8th week and 16th week after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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qigong, stroke, randomized controlled trial, body-mind exercise, balance, quality of life, wellbeing