Clinical trial NCT02999464: Effect of Qigong on Balance, Fall Efficacy, Wellbeing of People With Stroke in Hong Kong
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: stroke
qigong
randomized controlled trial
body-mind exercise
balance
quality of life
wellbeing
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2016-12-21
Enrollment: 58
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mini-BESTest.
timeFrame: Baseline, 8th week and 16th week after intervention
Secondary outcomes:
measure: Fall Efficacy Scale - International
timeFrame: Baseline, 8th week and 16th week after intervention
measure: Number of falls
timeFrame: Baseline, 8th week and 16th week after intervention
measure: Limit of Stability by using Balance Master
timeFrame: Baseline, 8th week and 16th week after intervention
measure: Geriatric Depression Scale
timeFrame: Baseline, 8th week and 16th week after intervention
measure: Five Times Sit to Stand Test
timeFrame: Baseline, 8th week and 16th week after intervention
measure: Timed Up and Go Test
timeFrame: Baseline, 8th week and 16th week after intervention
measure: Modified Barthel Index
timeFrame: Baseline, 8th week and 16th week after intervention
measure: Stroke-Specific Quality of Life Scale
timeFrame: Baseline, 8th week and 16th week after intervention
measure: Sensory Organization Test by using Balance Master
timeFrame: Baseline, 8th week and 16th week after intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Kowloon Hospital
state: China
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Yiu-chung PANG, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.