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The Effect of Tai Chi Exercise Among Elders With Sarcopenia

Primary Purpose

Sarcopenia in Elderly, Tai Chi

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Tai-Chi
Comprehensive training
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Sarcopenia in Elderly

Eligibility Criteria

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

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

Sites / Locations

  • China Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Tai Chi exercise

Comprehensive training

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 14, 2021
Last Updated
January 18, 2023
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05145036
Brief Title
The Effect of Tai Chi Exercise Among Elders With Sarcopenia
Official Title
The Effect of Tai Chi Exercise Among Elders With Sarcopenia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
April 29, 2022 (Actual)
Study Completion Date
September 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China Medical University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia in Elderly, Tai Chi

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tai Chi exercise
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Comprehensive training
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Tai-Chi
Other Intervention Name(s)
Ward-off, Rollback, Push, Press, Grab, Split, Elbow Strike, Shoulder Strike
Intervention Description
Tai Chi exercise could improve muscle performance, balance and have the benefit for fall down prevention in the elders and patients with frailty.
Intervention Type
Behavioral
Intervention Name(s)
Comprehensive training
Other Intervention Name(s)
Stretch exercise, Strengthening exercise, Balance training
Intervention Description
There are 3 exercises. Each session consisted of 10 minutes of warm-up, 40 minutes of Tai Chi, and 10 minutes of cool down.
Primary Outcome Measure Information:
Title
Appendicular skeletal muscle mass in kilograms
Description
The appendicular skeletal muscle mass is evaluated by bioelectrical impedance (BIA) analysis
Time Frame
baseline
Title
Change from baseline appendicular skeletal muscle mass at 8 weeks
Description
The appendicular skeletal muscle mass is evaluated by bioelectrical impedance (BIA) analysis
Time Frame
8 weeks
Title
Hand grip in kilograms
Description
The muscle strength is evaluated with the hand-grip strength (kg) by dynamometer
Time Frame
baseline
Title
Hand grip in kilograms
Description
The muscle strength is evaluated with the hand-grip strength (kg) by dynamometer
Time Frame
8 weeks
Title
Times Chair-stand test (5-CST) in minutes
Description
The 5CST is evaluated by recording the total time that patient repeat 5 times stand and sit motion from chair
Time Frame
baseline
Title
Times Chair-stand test (5-CST) in minutes
Description
The 5CST is evaluated by recording the total time that patient repeat 5 times stand and sit motion from chair
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
China Medicine University China Medicine University
Organizational Affiliation
China Medicine University
Official's Role
Study Chair
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan

12. IPD Sharing Statement

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The Effect of Tai Chi Exercise Among Elders With Sarcopenia

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