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

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Qigong
Fitness exercise
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, qigong, randomized controlled trial, body-mind exercise, balance, quality of life, wellbeing

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kowloon HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Qigong

Fitness Exercise

Arm Description

Experimental group will receive a total of 50 minutes of qigong training 3 times per week and for 16 weeks.

Fitness exercise group will receive home fitness exercise 3 times per week and for 16 weeks.

Outcomes

Primary Outcome Measures

Mini-BESTest.
Change from baseline balance capacity at 8 weeks and 16 weeks

Secondary Outcome Measures

Fall Efficacy Scale - International
Change from baseline fall efficacy of the subject at 8 weeks and 16 weeks
Number of falls
Limit of Stability by using Balance Master
Change from baseline postural stability at 8 weeks and 16 weeks
Geriatric Depression Scale
Five Times Sit to Stand Test
Lower extremity strength
Timed Up and Go Test
Change from baseline gait speed at 8 weeks and 16 weeks
Modified Barthel Index
Activities of daily living function
Stroke-Specific Quality of Life Scale
Sensory Organization Test by using Balance Master
Change from baseline postural control at 8 weeks and 16 weeks

Full Information

First Posted
April 24, 2016
Last Updated
January 15, 2017
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT02999464
Brief Title
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

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, qigong, randomized controlled trial, body-mind exercise, balance, quality of life, wellbeing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Qigong
Arm Type
Experimental
Arm Description
Experimental group will receive a total of 50 minutes of qigong training 3 times per week and for 16 weeks.
Arm Title
Fitness Exercise
Arm Type
Active Comparator
Arm Description
Fitness exercise group will receive home fitness exercise 3 times per week and for 16 weeks.
Intervention Type
Other
Intervention Name(s)
Qigong
Other Intervention Name(s)
body-mind exercise
Intervention Description
The experimental group will be required to practice a total of 50 minutes of qigong training 3 times per week and for 16 weeks
Intervention Type
Other
Intervention Name(s)
Fitness exercise
Intervention Description
Active control group will be required to practice a total of 50 minutes of fitness training 3 times per week and for 16 weeks
Primary Outcome Measure Information:
Title
Mini-BESTest.
Description
Change from baseline balance capacity at 8 weeks and 16 weeks
Time Frame
Baseline, 8th week and 16th week after intervention
Secondary Outcome Measure Information:
Title
Fall Efficacy Scale - International
Description
Change from baseline fall efficacy of the subject at 8 weeks and 16 weeks
Time Frame
Baseline, 8th week and 16th week after intervention
Title
Number of falls
Time Frame
Baseline, 8th week and 16th week after intervention
Title
Limit of Stability by using Balance Master
Description
Change from baseline postural stability at 8 weeks and 16 weeks
Time Frame
Baseline, 8th week and 16th week after intervention
Title
Geriatric Depression Scale
Time Frame
Baseline, 8th week and 16th week after intervention
Title
Five Times Sit to Stand Test
Description
Lower extremity strength
Time Frame
Baseline, 8th week and 16th week after intervention
Title
Timed Up and Go Test
Description
Change from baseline gait speed at 8 weeks and 16 weeks
Time Frame
Baseline, 8th week and 16th week after intervention
Title
Modified Barthel Index
Description
Activities of daily living function
Time Frame
Baseline, 8th week and 16th week after intervention
Title
Stroke-Specific Quality of Life Scale
Time Frame
Baseline, 8th week and 16th week after intervention
Title
Sensory Organization Test by using Balance Master
Description
Change from baseline postural control at 8 weeks and 16 weeks
Time Frame
Baseline, 8th week and 16th week after intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shuk-man YUEN, MPhil
Phone
852-9736-3529
Email
mandyyuensm@yahoo.com.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Yiu-chung PANG, PhD
Phone
852-2766-7156
Email
Marco.Pang@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yiu-chung PANG, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kowloon Hospital
City
Hong Kong
State/Province
China
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuk Man Yuen
Phone
852-3129-7140
Email
mandyyuensm@yahoo.com.hk
First Name & Middle Initial & Last Name & Degree
Tracy Chen
Phone
852-3129-7140

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33825587
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.
Results Reference
derived

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

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