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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05145036
Other study ID # CMUH110-REC2-107
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2021
Est. completion date September 28, 2022

Study information

Verified date January 2023
Source China Medical University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date September 28, 2022
Est. primary completion date April 29, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Tai-Chi
Tai Chi exercise could improve muscle performance, balance and have the benefit for fall down prevention in the elders and patients with frailty.
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.

Locations

Country Name City State
Taiwan China Medical University Hospital Taichung

Sponsors (1)

Lead Sponsor Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Appendicular skeletal muscle mass in kilograms The appendicular skeletal muscle mass is evaluated by bioelectrical impedance (BIA) analysis baseline
Primary Change from baseline appendicular skeletal muscle mass at 8 weeks The appendicular skeletal muscle mass is evaluated by bioelectrical impedance (BIA) analysis 8 weeks
Primary Hand grip in kilograms The muscle strength is evaluated with the hand-grip strength (kg) by dynamometer baseline
Primary Hand grip in kilograms The muscle strength is evaluated with the hand-grip strength (kg) by dynamometer 8 weeks
Primary 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 baseline
Primary 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 8 weeks
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