Cognitive DysfunctionNCT04904991
Three-month Chan-Chung Qigong Improves Physical Function Performance and Quality of Life
A study testing Chan-Chuang qigong in people with Cognitive Dysfunction and Cognitive Aging, run by Tri-Service General Hospital (TSGH).
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Dysfunction, Cognitive Aging, Grip
- What is being tested?
- Chan-Chuang qigong
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2016to 30 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Three-month Chan-Chung Qigong Program in Improving Physical Functional Performance and Quality of Life in Cognitive Impairment Patients
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.
Read the 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.
- Conditions
- Cognitive Dysfunction, Cognitive Aging, Grip, Exercise Training, Physical Endurance, Cognitive Decline
- Being tested
- Chan-Chuang qigong
- Keywords
- Cognitive inpairment, Qigong / Exercise, Muscle strength /endurance, Quality of life, Physical activity
- Medical subject headings
- Cognitive Dysfunction, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chan-Chuang qigongProcedure or surgery
Also called qigong group
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: Procedure: Chan-Chuang qigong |
| Control group | No intervention | those in the control group received usual care for cognitive impairment during the same study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start30 Aug 2016
- Primary completion4 Nov 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsu Chin-yun, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904991
- Sponsor's protocol ID
- 1-105-05-133
- Status last verified
- May 2021
- First submitted
- 13 Dec 2020
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-month Chan-Chung Qigong Program in Improving Physical Functional Performance and Quality of Life in Cognitive Impairment Patients
- ClinicalTrials.gov ID
- NCT04904991
- Acronym / sponsor ID
- 1-105-05-133
- Conditions
- Cognitive Dysfunction, Cognitive Aging, Grip, Exercise Training, Physical Endurance, Cognitive Decline
- Keywords
- Cognitive inpairment, Qigong / Exercise, Muscle strength /endurance, Quality of life, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 30 Aug 2016 (actual)
- Primary completion
- 4 Nov 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Qigong group | Experimental | Procedure: Chan-Chuang qigongParticipants 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 . |
| Control group | No intervention | –those in the control group received usual care for cognitive impairment during the same study period. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chan-Chuang qigongAlso: qigong groupThis 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. | Procedure or surgery | Qigong group |
Primary outcome
The findings of this study indicate Chan-Chuang qigong improved physical function performance with cognitive impairment.
Time frame: 3 months
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.
Time frame: 3 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Chan-Chuang qigong in people with Cognitive Dysfunction and Cognitive Aging, run by Tri-Service General Hospital (TSGH).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The findings of this study indicate Chan-Chuang qigong improved physical function performance with cognitive impairment. (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.