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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02999464
• Other study ID #: HSEARS20151013001
• Status: Recruiting
• Phase: N/A
• First received: April 24, 2016
• Last updated: January 15, 2017
• Start date: July 2016
• Est. completion date: July 2017

Study information

• Verified date: January 2017
• Source: The Hong Kong Polytechnic University
• Contact: Shuk-man YUEN, MPhil
• Phone: 852-9736-3529
• Email: mandyyuensm[@]yahoo.com.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Qigong
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 exercise
Active control group will be required to practice a total of 50 minutes of fitness training 3 times per week and for 16 weeks

Locations

Country	Name	City	State
Hong Kong	Kowloon Hospital	Hong Kong	China

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mini-BESTest.	Change from baseline balance capacity at 8 weeks and 16 weeks	Baseline, 8th week and 16th week after intervention
Secondary	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
Secondary	Number of falls		Baseline, 8th week and 16th week after intervention
Secondary	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
Secondary	Geriatric Depression Scale		Baseline, 8th week and 16th week after intervention
Secondary	Five Times Sit to Stand Test	Lower extremity strength	Baseline, 8th week and 16th week after intervention
Secondary	Timed Up and Go Test	Change from baseline gait speed at 8 weeks and 16 weeks	Baseline, 8th week and 16th week after intervention
Secondary	Modified Barthel Index	Activities of daily living function	Baseline, 8th week and 16th week after intervention
Secondary	Stroke-Specific Quality of Life Scale		Baseline, 8th week and 16th week after intervention
Secondary	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