NCT04904991

Brief Summary

The purpose of this study aimed to evaluate the effect of the three-month Chan-Chung qigong program in improving physical functional performance and quality of life in patients with mild to moderate cognitive impairments.A quasi-experimental design was adopted. Subjects were recruited from cognitive impairments outpatients these subjects,41were assigned to the control group and 41 to the experimental group in which Chan-Chuang qigong was administered.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2016

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 4, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2020

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 27, 2021

Completed
Last Updated

May 27, 2021

Status Verified

May 1, 2021

Enrollment Period

1.2 years

First QC Date

December 13, 2020

Last Update Submit

May 23, 2021

Conditions

Keywords

Cognitive inpairmentQigong / ExerciseMuscle strength /enduranceQuality of lifePhysical activity

Outcome Measures

Primary Outcomes (2)

  • The findings of this study indicate Chan-Chuang qigong improved physical function performance with cognitive impairment.

    this study considered the influences of cognition status and changes. After the intervention measures were implemented, the Qigong group had significant differences in physiological function, muscle endurance, and cardiopulmonary fitness compared with the control group.

    3 months

  • There was no significant between-group difference in the physical and mental components at baseline.

    However, a significant between-group difference was in the physical , not mental, component on Month 3. In addition, no significant within-group difference in either Qigong or control group

    3 months

Study Arms (2)

Qigong group

EXPERIMENTAL

Participants in the Qigong group were given a structured program about Chan-Chung qigong for 3 months which was a modified form of the manual of Chan-Chuang qigong (Yeh et al., 2006), to tailor to patients with cognitive impairment. The Chan-Chuang qigong program included warmup prior to qigong practice, preparation for qigong practice . The movements should be repeated and maintained for 10 minutes per time, 3 time a day .

Procedure: Chan-Chuang qigong

Control group

NO INTERVENTION

those in the control group received usual care for cognitive impairment during the same study period.

Interventions

This study applied the Chan-Chuang qigong program, which was a modified form of the manual of Chan-Chuang qigong (Yeh et al., 2006), to tailor to patients with cognitive impairment. The Chan-Chuang qigong program included warmup prior to qigong practice, preparation for qigong practice, core qigong of four moves, and cool down after qigong practice. The movements should be repeated and maintained for 10 minutes per time, 3 time a day (Yeh et al., 2006), totally 90 minutes per week, for 3 months. The guideline booklet of Chan-Chuang qigong (Chen et al., 2019; Chuang, Yeh, \& Chung, 2017) was modified and provided to the participants, which had major sections of introduction to qigong, preparation and precautions, practical procedures with description and photos, normal physical reactions from practicing core Chan-Chuang qigong, precautions of daily life, a confirmation sheet, and a checklist of qigong performance.

Also known as: qigong group
Qigong group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants invited in this study were aged more than 60 years, diagnosed with the Clinical Dementia Rating (CDR) ≦1, able to communicate, free to stand and walk, and willing to participate this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cognitive DysfunctionMotor Activity

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study randomized controlled trial with four repeated measurements was conducted between Apply 2016 and October 2017. Participants in the Qigong group were given a structured program about Chan-Chung qigong for 3 months; those in the control group received usual care for cognitive impairment during the same study period. The intervention effects were measured by muscular strength, muscular endurance, and 6-min walk distance at baseline, Month 1, Month 2, and Month 3. In addition, QoL was measured at baseline and Month 3.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Nurse

Study Record Dates

First Submitted

December 13, 2020

First Posted

May 27, 2021

Study Start

August 30, 2016

Primary Completion

November 4, 2017

Study Completion

December 30, 2017

Last Updated

May 27, 2021

Record last verified: 2021-05