NCT02999464

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
58

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
6 months until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

11 months

First QC Date

April 24, 2016

Last Update Submit

January 15, 2017

Conditions

Stroke

Keywords

strokeqigongrandomized controlled trialbody-mind exercisebalancequality of lifewellbeing

Outcome Measures

Primary Outcomes (1)

  • Mini-BESTest.

    Change from baseline balance capacity at 8 weeks and 16 weeks

    Baseline, 8th week and 16th week after intervention

Secondary Outcomes (9)

  • Fall Efficacy Scale - International

    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

    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

    Baseline, 8th week and 16th week after intervention

  • +4 more secondary outcomes

Study Arms (2)

Qigong

EXPERIMENTAL

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

Other: Qigong

Fitness Exercise

ACTIVE COMPARATOR

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

Other: Fitness exercise

Interventions

QigongOTHER

The experimental group will be required to practice a total of 50 minutes of qigong training 3 times per week and for 16 weeks

Also known as: body-mind exercise
Qigong
Fitness exerciseOTHER

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

Fitness Exercise

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kowloon Hospital

Hong Kong, China, Hong Kong

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33825587DERIVED

MeSH Terms

Conditions

Stroke

Interventions

QigongExercise Test

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Breathing ExercisesMind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy ModalitiesHeart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Yiu-chung PANG, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuk-man YUEN, MPhil

CONTACT

852-9736-3529mandyyuensm@yahoo.com.hk

Yiu-chung PANG, PhD

CONTACT

852-2766-7156Marco.Pang@polyu.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 24, 2016

First Posted

December 21, 2016

Study Start

July 1, 2016

Primary Completion

June 1, 2017

Study Completion

July 1, 2017

Last Updated

January 18, 2017

Record last verified: 2017-01

Locations

HK(1)