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Three-month Chan-Chung Qigong Improves Physical Function Performance and Quality of Life

Primary Purpose

Cognitive Dysfunction, Cognitive Aging, Grip

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Chan-Chuang qigong
Sponsored by
Tri-Service General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Dysfunction focused on measuring Cognitive inpairment, Qigong / Exercise, Muscle strength /endurance, Quality of life, Physical activity

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • The exclusion criteria were as followings: use of hormone drugs, brain trauma, head surgery, vitamin B12 deficiency, decreased memory and judgment due to hypothyroidism or malnutrition with medical contraindications for exercise, and practicing qigong or exercise regularly.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Qigong group

    Control group

    Arm Description

    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 .

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

    Outcomes

    Primary Outcome Measures

    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.
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    December 13, 2020
    Last Updated
    May 23, 2021
    Sponsor
    Tri-Service General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04904991
    Brief Title
    Three-month Chan-Chung Qigong Improves Physical Function Performance and Quality of Life
    Official Title
    Three-month Chan-Chung Qigong Program in Improving Physical Functional Performance and Quality of Life in Cognitive Impairment Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    August 30, 2016 (Actual)
    Primary Completion Date
    November 4, 2017 (Actual)
    Study Completion Date
    December 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Tri-Service General Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cognitive Dysfunction, Cognitive Aging, Grip, Exercise Training, Physical Endurance, Cognitive Decline
    Keywords
    Cognitive inpairment, Qigong / Exercise, Muscle strength /endurance, Quality of life, Physical activity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    92 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Qigong group
    Arm Type
    Experimental
    Arm Description
    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 .
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    those in the control group received usual care for cognitive impairment during the same study period.
    Intervention Type
    Procedure
    Intervention Name(s)
    Chan-Chuang qigong
    Other Intervention Name(s)
    qigong group
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    The findings of this study indicate Chan-Chuang qigong improved physical function performance with cognitive impairment.
    Description
    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.
    Time Frame
    3 months
    Title
    There was no significant between-group difference in the physical and mental components at baseline.
    Description
    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
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: The exclusion criteria were as followings: use of hormone drugs, brain trauma, head surgery, vitamin B12 deficiency, decreased memory and judgment due to hypothyroidism or malnutrition with medical contraindications for exercise, and practicing qigong or exercise regularly.

    12. IPD Sharing Statement

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