- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05767710
A Study of the Telerehabiliation Intervention Effect of the Tai Chi Exercise on Elderly With Sarcopenia
An Alternative Remote Rehabilitation Strategy for the Improvement of Sarcopenia in the Elderly: Tai Chi as an Exercise Form
Study Overview
Status
Conditions
Intervention / Treatment
- Behavioral: AI telerehabilitation - Tai Chi
- Behavioral: general telerehabilitation - Tai Chi
- Behavioral: traditional rehabilitation - Tai Chi
- Behavioral: AI telerehabilitation - Yi Jin Jing
- Behavioral: general telerehabilitation - Yi Jin Jing
- Behavioral: traditional rehabilitation - Yi Jin Jing
- Behavioral: AI telerehabilitation - Ba Duan Jin
- Behavioral: general telerehabilitation - Ba Duan Jin
- Behavioral: traditional rehabilitation - Ba Duan Jin
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Jilin
-
Changchun, Jilin, China, 130024
- Recruiting
- Chinese Center of Exercise Epidemiology
-
Contact:
- Guang Yang, PhD
- Phone Number: +86 13204470884
- Email: yangg100@nenu.edu.cn
-
Contact:
- Deyu Meng, Master
- Phone Number: +86 17808086110
- Email: mengdy539@nenu.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
(1) Patients between the ages of 60-75 years; (2) who meet the screening criteria for sarcopenia in Asia established by AWGS 2019; (3) who have a computer at home (4) who can use a computer or was accompanied by family number who can use a computer.
Exclusion Criteria:
(1) participants taking medications that significantly impact musculoskeletal function (2) participants suffering from respiratory failure or other bodily problems; (3) participants with mental disorders or neurological disorders; (4) patients who participate in other training programs on a regular basis.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AI telerehabilitation - Tai Chi
All sessions were conducted online, with participants practicing along with Tai Chi videos while the AI guided the movements throughout the session.
A remote rehabilitation program was installed in patients' homes by study team members.
Participants who do not know how to use a computer were assisted by their family members.
|
All the participants received a three-month intervention which consisted two stage: the first month was the movement learning and consolidation phase, with 45 minutes of Tai Chi practice per session and three times each week; the last two months were the formal practice phase with 45 minutes of Tai Chi practice per session and three times each week.
In the first phase, participants learned four new movements in each session and consolidated these exercises in the next session.
After all the movements have been learned, use the remaining time in the first stage to consolidate the exercises.
In the second phase, participants performed a complete Tai Chi exercise in each session.
|
|
Active Comparator: general telerehabilitation - Tai Chi
All sessions were conducted in an online format, with participants practicing along with Tai Chi videos while the professional Tai Chi instructors supervised and guided the movements throughout the session.
A computer connected to a high-resolution webcam was used to establish real-time remote visual communication between the rehabilitation unit and the patient's home via Tencent conferencing software (Meeting/Tencent).
|
All the participants received a three-month intervention which consisted two stage: the first month was the movement learning and consolidation phase, with 45 minutes of Tai Chi practice per session and three times each week; the last two months were the formal practice phase with 45 minutes of Tai Chi practice per session and three times each week.
In the first phase, participants learned four new movements in each session and consolidated these exercises in the next session.
After all the movements have been learned, use the remaining time in the first stage to consolidate the exercises.
In the second phase, participants performed a complete Tai Chi exercise in each session.
|
|
Active Comparator: traditional rehabilitation - Tai Chi
All sessions were conducted offline and implemented by professional Tai Chi instructors.
The audio from the video used for the other two groups was utilized to assist the practice of participants in traditional rehabilitation - Tai Chi group.
|
All the participants received a three-month intervention which consisted two stage: the first month was the movement learning and consolidation phase, with 45 minutes of Tai Chi practice per session and three times each week; the last two months were the formal practice phase with 45 minutes of Tai Chi practice per session and three times each week.
In the first phase, participants learned four new movements in each session and consolidated these exercises in the next session.
After all the movements have been learned, use the remaining time in the first stage to consolidate the exercises.
In the second phase, participants performed a complete Tai Chi exercise in each session.
|
|
Experimental: AI telerehabilitation - Yi Jin Jing
All sessions were conducted online, with participants practicing along with Yi Jin Jing videos while the AI guided the movements throughout the session.
A remote rehabilitation program was installed in patients' homes by study team members.
Participants who do not know how to use a computer were assisted by their family members.
|
All the participants received a three-month intervention which consisted two stage: the first month was the movement learning and consolidation phase, with 45 minutes of Yi Jin Jing practice per session and three times each week; the last two months were the formal practice phase with 45 minutes of Yi Jin Jing practice per session and three times each week.
In the first phase, participants learned four new movements in each session and consolidated these exercises in the next session.
After all the movements have been learned, use the remaining time in the first stage to consolidate the exercises.
In the second phase, participants performed a complete Yi Jin Jing exercise in each session.
|
|
Active Comparator: general telerehabilitation - Yi Jin Jing
All sessions were conducted in an online format, with participants practicing along with Yi Jin Jing videos while the professional Yi Jin Jing instructors supervised and guided the movements throughout the session.
A computer connected to a high-resolution webcam was used to establish real-time remote visual communication between the rehabilitation unit and the patient's home via Tencent conferencing software (Meeting/Tencent).
|
All the participants received a three-month intervention which consisted two stage: the first month was the movement learning and consolidation phase, with 45 minutes of Yi Jin Jing practice per session and three times each week; the last two months were the formal practice phase with 45 minutes of Yi Jin Jing practice per session and three times each week.
In the first phase, participants learned four new movements in each session and consolidated these exercises in the next session.
After all the movements have been learned, use the remaining time in the first stage to consolidate the exercises.
In the second phase, participants performed a complete Yi Jin Jing exercise in each session.
|
|
Active Comparator: traditional rehabilitation - Yi Jin Jing
All sessions were conducted offline and implemented by professional Yi Jin Jing instructors.
The audio from the video used for the other two groups was utilized to assist the practice of participants in traditional rehabilitation - Yi Jin Jing group.
|
All the participants received a three-month intervention which consisted two stage: the first month was the movement learning and consolidation phase, with 45 minutes of Yi Jin Jing practice per session and three times each week; the last two months were the formal practice phase with 45 minutes of Yi Jin Jing practice per session and three times each week.
In the first phase, participants learned four new movements in each session and consolidated these exercises in the next session.
After all the movements have been learned, use the remaining time in the first stage to consolidate the exercises.
In the second phase, participants performed a complete Yi Jin Jing exercise in each session.
|
|
Experimental: AI telerehabilitation - Ba Duan Jin
All sessions were conducted online, with participants practicing along with Ba Duan Jin videos while the AI guided the movements throughout the session.
A remote rehabilitation program was installed in patients' homes by study team members.
Participants who do not know how to use a computer were assisted by their family members.
|
All the participants received a three-month intervention which consisted two stage: the first month was the movement learning and consolidation phase, with 45 minutes of Ba Duan Jin practice per session and three times each week; the last two months were the formal practice phase with 45 minutes of Ba Duan Jin practice per session and three times each week.
In the first phase, participants learned four new movements in each session and consolidated these exercises in the next session.
After all the movements have been learned, use the remaining time in the first stage to consolidate the exercises.
In the second phase, participants performed a complete Ba Duan Jin exercise in each session.
|
|
Active Comparator: general telerehabilitation - Ba Duan Jin
All sessions were conducted in an online format, with participants practicing along with Ba Duan Jin videos while the professional Ba Duan Jin instructors supervised and guided the movements throughout the session.
A computer connected to a high-resolution webcam was used to establish real-time remote visual communication between the rehabilitation unit and the patient's home via Tencent conferencing software (Meeting/Tencent).
|
All the participants received a three-month intervention which consisted two stage: the first month was the movement learning and consolidation phase, with 45 minutes of Ba Duan Jin practice per session and three times each week; the last two months were the formal practice phase with 45 minutes of Ba Duan Jin practice per session and three times each week.
In the first phase, participants learned four new movements in each session and consolidated these exercises in the next session.
After all the movements have been learned, use the remaining time in the first stage to consolidate the exercises.
In the second phase, participants performed a complete Ba Duan Jin exercise in each session.
|
|
Active Comparator: traditional rehabilitation - Ba Duan Jin
All sessions were conducted offline and implemented by professional Ba Duan Jin instructors.
The audio from the video used for the other two groups was utilized to assist the practice of participants in traditional rehabilitation - Ba Duan Jin group.
|
All the participants received a three-month intervention which consisted two stage: the first month was the movement learning and consolidation phase, with 45 minutes of Ba Duan Jin practice per session and three times each week; the last two months were the formal practice phase with 45 minutes of Ba Duan Jin practice per session and three times each week.
In the first phase, participants learned four new movements in each session and consolidated these exercises in the next session.
After all the movements have been learned, use the remaining time in the first stage to consolidate the exercises.
In the second phase, participants performed a complete Ba Duan Jin exercise in each session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Using quantitative CT to investigate the change of skeletal muscle area in sarcopenic elderly.
Time Frame: Month 3
|
articipants will receive quantitative CT scans before and after the intervention to assess the change from baseline skeletal muscle area at 3 months.
|
Month 3
|
|
Using a Jamar hydraulic hand dynamometer to investigate change of handgrip in sarcopenic elderly.
Time Frame: Month 3
|
Participants will receive a handgrip strength test before and after the intervention to assess the change from baseline handgrip strength at 3 months.
|
Month 3
|
|
Using a bioelectrical impedance body composition analyzer with a multifrequency device to investigate the change of relative skeletal muscle mass index in sarcopenic elderly.
Time Frame: Month 3
|
Participants will receive a relative skeletal muscle mass index test before and after the intervention to assess the change from baseline relative skeletal muscle index at 3 months.
|
Month 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Collect participants' self-evaluation of their life state and physical state.
Time Frame: Month 3
|
Participants were asked to write a self-assessment report of no more than 500 words before and after the intervention, including physical status and life status.
|
Month 3
|
|
Collect video of participants throughout the intervention.
Time Frame: Month 3
|
The entire intervention process was recorded and video of the entire intervention process was collected from the participants.
|
Month 3
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCEE2023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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