- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05145036
The Effect of Tai Chi Exercise Among Elders With Sarcopenia
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Taichung, Taiwan
- China Medical University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Tai Chi exercise
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.
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Tai Chi exercise could improve muscle performance, balance and have the benefit for fall down prevention in the elders and patients with frailty.
Other Names:
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Active Comparator: Comprehensive training
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.
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There are 3 exercises.
Each session consisted of 10 minutes of warm-up, 40 minutes of Tai Chi, and 10 minutes of cool down.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Appendicular skeletal muscle mass in kilograms
Time Frame: baseline
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The appendicular skeletal muscle mass is evaluated by bioelectrical impedance (BIA) analysis
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baseline
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Change from baseline appendicular skeletal muscle mass at 8 weeks
Time Frame: 8 weeks
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The appendicular skeletal muscle mass is evaluated by bioelectrical impedance (BIA) analysis
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8 weeks
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Hand grip in kilograms
Time Frame: baseline
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The muscle strength is evaluated with the hand-grip strength (kg) by dynamometer
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baseline
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Hand grip in kilograms
Time Frame: 8 weeks
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The muscle strength is evaluated with the hand-grip strength (kg) by dynamometer
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8 weeks
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Times Chair-stand test (5-CST) in minutes
Time Frame: baseline
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The 5CST is evaluated by recording the total time that patient repeat 5 times stand and sit motion from chair
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baseline
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Times Chair-stand test (5-CST) in minutes
Time Frame: 8 weeks
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The 5CST is evaluated by recording the total time that patient repeat 5 times stand and sit motion from chair
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8 weeks
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMUH110-REC2-107
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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