NCT05145036

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 6, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2022

Completed
Last Updated

January 19, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

October 14, 2021

Last Update Submit

January 18, 2023

Conditions

Outcome Measures

Primary Outcomes (6)

  • Appendicular skeletal muscle mass in kilograms

    The appendicular skeletal muscle mass is evaluated by bioelectrical impedance (BIA) analysis

    baseline

  • Change from baseline appendicular skeletal muscle mass at 8 weeks

    The appendicular skeletal muscle mass is evaluated by bioelectrical impedance (BIA) analysis

    8 weeks

  • Hand grip in kilograms

    The muscle strength is evaluated with the hand-grip strength (kg) by dynamometer

    baseline

  • Hand grip in kilograms

    The muscle strength is evaluated with the hand-grip strength (kg) by dynamometer

    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

    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

    8 weeks

Study Arms (2)

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.

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.

Behavioral: Comprehensive training

Interventions

Tai-ChiBEHAVIORAL

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

Also known as: Ward-off, Rollback, Push, Press, Grab, Split, Elbow Strike, Shoulder Strike
Tai Chi exercise

There are 3 exercises. Each session consisted of 10 minutes of warm-up, 40 minutes of Tai Chi, and 10 minutes of cool down.

Also known as: Stretch exercise, Strengthening exercise, Balance training
Comprehensive training

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, Taiwan

Location

MeSH Terms

Interventions

Tai JiIPS e.max PressPlyometric Exercise

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy ModalitiesExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CarePhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • China Medicine University China Medicine University

    China Medicine University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2021

First Posted

December 6, 2021

Study Start

December 1, 2021

Primary Completion

April 29, 2022

Study Completion

September 28, 2022

Last Updated

January 19, 2023

Record last verified: 2023-01

Locations