Sarcopenia in ElderlyNCT05145036
The Effect of Tai Chi Exercise Among Elders With Sarcopenia
A study testing Tai-Chi and Comprehensive training in people with Sarcopenia in Elderly and Tai Chi, run by China Medical University Hospital at 1 site in Taiwan.
Trial summary
Sarcopenia has been defined as a disease which presented as low muscles strength, low muscle quantity or quality and low physical activity. The prevalence of sarcopenia is increasing with the age and it is also included in one of geriatric syndromes. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia in Elderly, Tai Chi
- What is being tested?
- Tai-Chi and Comprehensive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2021to 28 Sep 2022
- 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
- Age 60 or older;
- With a diagnosis of sarcopenia [defined as EWGSOP-2] (6);
- Without planned exercise program or unplanned admission in 6 months;
- Could tolerate tests of muscle power and strength.
Who cannot join
- Uncontrolled diabetes mellitus;
- Uncontrolled cardiovascular diseases;
- Uncontrolled hypertension;
- Knee or hip prosthesis, pacemaker, fracture in the previous 6 months,
- Critical cognitive (MMSE<23)
- Mini Nutritional Assessment (MNA <17)
- Physical dysfunctions that could not tolerate our tests
Trial locations and contacts
1 site in 1 country.
About this study
Sarcopenia has been defined as a disease which presented as low muscles strength, low muscle quantity or quality and low physical activity. The prevalence of sarcopenia is increasing with the age and it is also included in one of geriatric syndromes. Several criteria have been mentioned for diagnosis of sarcopenia, such as European Working Group on Sarcopenia in Older People (EWGSOP)、Foundation for the National Institutes of Health Biomarkers Consortium Sarcopenia Project (FNIH) and Asian Working Group for Sarcopenia (AWGS).
In European, the prevalence rate of sarcopenia is 9.25-18%; 5-7% Canadian and 14.4% Taiwanese elders have been diagnosed as sarcopenia, respectively. The sarcopenia has been found its relationship with adverse outcomes of fall down, fracture, disability, and death. The cytokines and decline in anabolic hormones play a role in the pathogenesis of sarcopenia. Tai Chi exercise is one of Qigong and well-popular in Chinese population, and is helpful to integration of body movements. Tai Chi exercise is less complicated and emphasized people's awareness of self-care which presented the relationship between human and nature. Tai Chi exercise could improve muscle performance, balance and have the benefit for fall down prevention in the elders and patients with frailty. Furthermore, Tai Chi has been found that it also could improve the muscle power and power strength in sarcopenic elders by team training. Furthermore, immune makers of inflammation process have been noted their diminishments by Qigong intervention.
The aim of this study is to investigate the effect of Tai Chi exercise in sarcopenic elders through practicing at home. The differences of muscles strength, muscle quantity or quality and physical activity after interventions would be recorded and analyzed. The cytokines related to the sarcopenia process would also be sampled.
- Conditions
- Sarcopenia in Elderly, Tai Chi
- Being tested
- Tai-Chi, Comprehensive training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai-ChiBehavioural
Also called Ward-off, Rollback, Push, Press
Tai Chi exercise could improve muscle performance, balance and have the benefit for fall down prevention in the elders and patients with frailty.
Comprehensive trainingBehavioural
Also called Stretch exercise, Strengthening exercise, Balance training
There are 3 exercises. Each session consisted of 10 minutes of warm-up, 40 minutes of Tai Chi, and 10 minutes of cool down.
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi exercise | Active comparator | In addition to standard of care participants will be asked to apply Tai Chi. There are 8 movements. Each session consisted of 10 minutes of warm-up, 40 minutes of Tai Chi, and 10 minutes of cool down. The 8 movements are: Ward-off, Rollback, Push, Press, Grab, Split, Elbow strike, and shoulder strike. Receives: Behavioral: Tai-Chi |
| Comprehensive training | Active comparator | In addition to standard of care participants will be asked to apply Comprehensive training. There are 3 exercises. Each session consisted of 10 minutes of warm-up, 40 minutes of Tai Chi, and 10 minutes of cool down. The 8 movements are: stretch exercise, strengthening exercise, and balance exercise. Receives: Behavioral: Comprehensive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Appendicular skeletal muscle mass in kilograms
The appendicular skeletal muscle mass is evaluated by bioelectrical impedance (BIA) analysis
Measured: baseline
Change from baseline appendicular skeletal muscle mass at 8 weeks
The appendicular skeletal muscle mass is evaluated by bioelectrical impedance (BIA) analysis
Measured: 8 weeks
Hand grip in kilograms
The muscle strength is evaluated with the hand-grip strength (kg) by dynamometer
Measured: baseline
Hand grip in kilograms
The muscle strength is evaluated with the hand-grip strength (kg) by dynamometer
Measured: 8 weeks
Times Chair-stand test (5-CST) in minutes
The 5CST is evaluated by recording the total time that patient repeat 5 times stand and sit motion from chair
Measured: baseline
Times Chair-stand test (5-CST) in minutes
The 5CST is evaluated by recording the total time that patient repeat 5 times stand and sit motion from chair
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start1 Dec 2021
- Primary completion29 Apr 2022
- Study completion28 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenia in ElderlyStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- China Medicine University China Medicine University, Study chair, China Medicine University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145036
- Sponsor's protocol ID
- CMUH110-REC2-107
- Status last verified
- Jan 2023
- First submitted
- 14 Oct 2021
- Last updated
- 19 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tai Chi Exercise Among Elders With Sarcopenia
- ClinicalTrials.gov ID
- NCT05145036
- Acronym / sponsor ID
- CMUH110-REC2-107
- Conditions
- Sarcopenia in Elderly, Tai Chi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 29 Apr 2022 (actual)
- Study completion
- 28 Sep 2022 (actual)
- First posted
- 6 Dec 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.
Sarcopenia has been defined as a disease which presented as low muscles strength, low muscle quantity or quality and low physical activity. The prevalence of sarcopenia is increasing with the age and it is also included in one of geriatric syndromes. Several criteria have been mentioned for diagnosis of sarcopenia, such as European Working Group on Sarcopenia in Older People (EWGSOP)、Foundation for the National Institutes of Health Biomarkers Consortium Sarcopenia Project (FNIH) and Asian Working Group for Sarcopenia (AWGS).
In European, the prevalence rate of sarcopenia is 9.25-18%; 5-7% Canadian and 14.4% Taiwanese elders have been diagnosed as sarcopenia, respectively. The sarcopenia has been found its relationship with adverse outcomes of fall down, fracture, disability, and death. The cytokines and decline in anabolic hormones play a role in the pathogenesis of sarcopenia. Tai Chi exercise is one of Qigong and well-popular in Chinese population, and is helpful to integration of body movements. Tai Chi exercise is less complicated and emphasized people's awareness of self-care which presented the relationship between human and nature. Tai Chi exercise could improve muscle performance, balance and have the benefit for fall down prevention in the elders and patients with frailty. Furthermore, Tai Chi has been found that it also could improve the muscle power and power strength in sarcopenic elders by team training. Furthermore, immune makers of inflammation process have been noted their diminishments by Qigong intervention.
The aim of this study is to investigate the effect of Tai Chi exercise in sarcopenic elders through practicing at home. The differences of muscles strength, muscle quantity or quality and physical activity after interventions would be recorded and analyzed. The cytokines related to the sarcopenia process would also be sampled.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai Chi exercise | Active comparator | Behavioral: Tai-ChiIn addition to standard of care participants will be asked to apply Tai Chi. There are 8 movements. Each session consisted of 10 minutes of warm-up, 40 minutes of Tai Chi, and 10 minutes of cool down. The 8 movements are: Ward-off, Rollback, Push, Press, Grab, Split, Elbow strike, and shoulder strike. |
| Comprehensive training | Active comparator | Behavioral: Comprehensive trainingIn addition to standard of care participants will be asked to apply Comprehensive training. There are 3 exercises. Each session consisted of 10 minutes of warm-up, 40 minutes of Tai Chi, and 10 minutes of cool down. The 8 movements are: stretch exercise, strengthening exercise, and balance exercise. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 60 or older;
- With a diagnosis of sarcopenia [defined as EWGSOP-2] (6);
- Without planned exercise program or unplanned admission in 6 months;
- Could tolerate tests of muscle power and strength.
Key exclusion criteria (7 listed)
- Uncontrolled diabetes mellitus;
- Uncontrolled cardiovascular diseases;
- Uncontrolled hypertension;
- Knee or hip prosthesis, pacemaker, fracture in the previous 6 months,
- Critical cognitive (MMSE<23)
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 |
|---|---|---|
| Tai-ChiAlso: Ward-off, Rollback, Push, PressTai Chi exercise could improve muscle performance, balance and have the benefit for fall down prevention in the elders and patients with frailty. | Behavioural | Tai Chi exercise |
| Comprehensive trainingAlso: Stretch exercise, Strengthening exercise, Balance trainingThere are 3 exercises. Each session consisted of 10 minutes of warm-up, 40 minutes of Tai Chi, and 10 minutes of cool down. | Behavioural | Comprehensive training |
Primary outcome
Appendicular skeletal muscle mass in kilograms
Time frame: baseline
The appendicular skeletal muscle mass is evaluated by bioelectrical impedance (BIA) analysis
Change from baseline appendicular skeletal muscle mass at 8 weeks
Time frame: 8 weeks
The appendicular skeletal muscle mass is evaluated by bioelectrical impedance (BIA) analysis
Hand grip in kilograms
Time frame: baseline
The muscle strength is evaluated with the hand-grip strength (kg) by dynamometer
Hand grip in kilograms
Time frame: 8 weeks
The muscle strength is evaluated with the hand-grip strength (kg) by dynamometer
Times Chair-stand test (5-CST) in minutes
Time frame: baseline
The 5CST is evaluated by recording the total time that patient repeat 5 times stand and sit motion from chair
Times Chair-stand test (5-CST) in minutes
Time frame: 8 weeks
The 5CST is evaluated by recording the total time that patient repeat 5 times stand and sit motion from chair
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 19 Jan 2023.
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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.
China Medicine University China Medicine University study chair
China Medicine University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai-Chi and Comprehensive training in people with Sarcopenia in Elderly and Tai Chi, run by China Medical University Hospital at 1 site in Taiwan.
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 4 inclusion and 7 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 19 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Appendicular skeletal muscle mass in kilograms (time frame: baseline). The study lists 6 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 19 Jan 2023.