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

January 15, 2017 updated by: Yuen Shuk Man, The Hong Kong Polytechnic University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
    • China
      • Hong Kong, China, Hong Kong
        • Recruiting
        • Kowloon Hospital
        • Contact:
        • Contact:
          • Tracy Chen
          • Phone Number: 852-3129-7140

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Qigong
Experimental group will receive a total of 50 minutes of qigong training 3 times per week and for 16 weeks.
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
Other Names:
  • body-mind exercise
Active Comparator: Fitness Exercise
Fitness exercise group will receive home fitness exercise 3 times per week and for 16 weeks.
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mini-BESTest.
Time Frame: Baseline, 8th week and 16th week after intervention
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
Time Frame: Baseline, 8th week and 16th week after intervention
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
Time Frame: Baseline, 8th week and 16th week after intervention
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
Change from baseline postural stability at 8 weeks and 16 weeks
Baseline, 8th week and 16th week after intervention
Geriatric Depression Scale
Time Frame: Baseline, 8th week and 16th week after intervention
Baseline, 8th week and 16th week after intervention
Five Times Sit to Stand Test
Time Frame: Baseline, 8th week and 16th week after intervention
Lower extremity strength
Baseline, 8th week and 16th week after intervention
Timed Up and Go Test
Time Frame: Baseline, 8th week and 16th week after intervention
Change from baseline gait speed at 8 weeks and 16 weeks
Baseline, 8th week and 16th week after intervention
Modified Barthel Index
Time Frame: Baseline, 8th week and 16th week after intervention
Activities of daily living function
Baseline, 8th week and 16th week after intervention
Stroke-Specific Quality of Life Scale
Time Frame: Baseline, 8th week and 16th week after intervention
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
Change from baseline postural control at 8 weeks and 16 weeks
Baseline, 8th week and 16th week after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Investigators

  • Principal Investigator: Yiu-chung PANG, PhD, The Hong Kong Polytechnic University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

April 24, 2016

First Submitted That Met QC Criteria

December 17, 2016

First Posted (Estimate)

December 21, 2016

Study Record Updates

Last Update Posted (Estimate)

January 18, 2017

Last Update Submitted That Met QC Criteria

January 15, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSEARS20151013001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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