- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05694117
A Study of the Intervention Effect of a Hybrid Exercise Program on Elderly With Sarcopenia
February 6, 2023 updated by: Guang Yang, Prof. Dr., Northeast Normal University
White Box Modeling of Self-Determine Sequence Exercise Program Among Sarcopenic Elderly: Uncovers a Novel Strategy Overcoming Decline of Skeletal Muscle Area
Sarcopenia is a geriatric condition characterized by a progressive decrease in skeletal muscle content and loss of muscle function.
Resistance exercise, Taichi exercise and the hybrid exercise program consisting of the two aforementioned methods have been demonstrated could increase the skeletal muscle mass of the elderly with sarcopenia.
However, note that the above contents may be performed in a different order in a treatment, equally important but less well understood is the sequence in which it should be performed.
Surprisingly, the exercise sequence has not been comprehensively investigated.
Therefore, investigators designed a self-ordered exercise program combining resistance exercise, tai chi and a hybrid exercise program to investigate whether the decline in skeletal muscle area could be better overcome and the reversal of sarcopenia in elderly with sarcopenia.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
392
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Jilin
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Changchun, Jilin, China, 130024
- Chinese Center of Exercise Epidemiology
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- satisfied the Asian screening criteria for sarcopenia by the Asian Working Group for Sarcopenia;
- age higher than 60 but less than 75 years of age.
Exclusion Criteria:
- with serious illness or breathing failure;
- with neuro-muscular diseases;
- taking medication that has an effect on the function of skeletal muscles;
- with conditions relating to the neurological system or the mental health;
- in another scheduled training plan.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: self-determine sequence exercise program
The trial was divided into three cycles, and participants were allowed to choose any one of the a Taichi exercise program, a hybrid program of Taichi exercise and resistance training programs, and resistance training as their intervention content before the start of each cycle.
Participants who chose Taichi exercise performed one hour of Taichi exercise for each session, while participants who chose a hybrid exercise program of Taichi exercise and resistance training completed Taichi exercise in the first half hour and resistance training for the second half hour.
Participants who chose resistance training performed one hour of resistance training.
One hour per training session, three times a week for 24 weeks
|
The Taichi exercise utilized the simplified eight styles of Taichi.
The resistance training program consisted of three cycles.
In the first cycle, investigators used a light load but high repetitions (ranging from 40% to 60% of one repetition maximum and 12-20 repetitions).
During the second phase of our training, investigators raised the training load by doing sets of moderate intensity and a medium number of repetitions (ranging from 60% to 80% of one repetition maximum and 5-12 repetitions).
In the third cycle, investigators aimed to improve the participants' maximal muscular resistance by using a greater training load and fewer repetitions (ranging from 70% to 85% of one repetition maximum and 5-8 repetitions).
|
|
EXPERIMENTAL: resistance training
Resistance strength training for resistance exercise and aimed at promoting the greatest hypertrophy response.
Training is divided into three cycles, with progressive training load.
Resistance exercise intervention three times a week for 24 weeks, one hour each time.
|
The resistance training program consisted of three cycles.
In the first cycle, investigators used a light load but high repetitions (ranging from 40% to 60% of one repetition maximum and 12-20 repetitions).
During the second phase of our training, investigators raised the training load by doing sets of moderate intensity and a medium number of repetitions (ranging from 60% to 80% of one repetition maximum and 5-12 repetitions).
In the third cycle, investigators aimed to improve the participants' maximal muscular resistance by using a greater training load and fewer repetitions (ranging from 70% to 85% of one repetition maximum and 5-8 repetitions).
Participants in the RTG completed four sets of each movement, with two to three minutes of rest between each set.
|
|
NO_INTERVENTION: control group
The participants in the control group were introduced by nurses to education about sarcopenia and various methods for preventing it, such as consuming more protein through their diet and participating in greater physical exercise.
|
|
|
EXPERIMENTAL: Taichi exercise and resistance training
The trial was divided into three cycles, each lasting eight weeks.
Participants performed a hybrid program of Taichi exercise and resistance training of varying duration and intensity in each cycle.
Each session lasted one hour, three times a week for 24 weeks.
|
The training of the Taichi exercise and resistance training group consisted of two cycles, the first cycle was aimed at learning and consolidating Taichi exercise, and the second cycle was aimed at improving and consolidating.
The Taichi exercise and resistance training group was scheduled for 30 min of Taichi exercise per training.
The resistance training program consisted of three cycles.
In the first cycle, investigators used a light load but high repetitions (ranging from 40% to 60% of one repetition maximum and 12-20 repetitions).
During the second phase of our training, investigators raised the training load by doing sets of moderate intensity and a medium number of repetitions (ranging from 60% to 80% of one repetition maximum and 5-12 repetitions).
In the third cycle, investigators aimed to improve the participants' maximal muscular resistance by using a greater training load and fewer repetitions (ranging from 70% to 85% of one repetition maximum and 5-8 repetitions).
|
|
EXPERIMENTAL: Randomly selected exercise program
The trial was divided into three cycles, and participants were allowed to choose any one of the a Yijinjing exercise program, a hybrid program of Yijinjing exercise and resistance training programs, and resistance training as their intervention content before the start of each cycle.
Participants who chose Yijinjing exercise performed one hour of Yijinjing exercise for each session, while participants who chose a hybrid exercise program of Yijinjing exercise and resistance training completed Yijinjing exercise in the first half hour and resistance training for the second half hour.
Participants who chose resistance training performed one hour of resistance training.
One hour per training session, three times a week for 24 weeks
|
Participants in the randomly selected exercise program group who chose Yijinjing exercise were required to complete one hour of Yijinjing exercise training, and those who chose Yijinjing exercise hybrid strength training had to complete half an hour of Yijinjing training.
The resistance training program consisted of three cycles.
In the first cycle, investigators used a light load but high repetitions (ranging from 40% to 60% of one repetition maximum and 12-20 repetitions).
During the second phase of our training, investigators raised the training load by doing sets of moderate intensity and a medium number of repetitions (ranging from 60% to 80% of one repetition maximum and 5-12 repetitions).
In the third cycle, investigators aimed to improve the participants' maximal muscular resistance by using a greater training load and fewer repetitions (ranging from 70% to 85% of one repetition maximum and 5-8 repetitions).
|
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 6
|
Participants will receive quantitative CT scans before and after the intervention to assess the change from baseline skeletal muscle area at 6 months.
|
Month 6
|
|
Using a Jamar hydraulic hand dynamometer to investigate change of handgrip in sarcopenic elderly.
Time Frame: Month 6
|
Participants will receive a handgrip strength test before and after the intervention to assess the change from baseline handgrip strength at 6 months.
|
Month 6
|
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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 6
|
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 6 months.
|
Month 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Collect participants' self-evaluation of their life state and physical state.
Time Frame: Month 6
|
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.
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Month 6
|
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Collect video of participants throughout the intervention.
Time Frame: Month 6
|
The entire intervention process was videotaped and video of the entire intervention process was collected from the participants.
|
Month 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 20, 2019
Primary Completion (ACTUAL)
December 31, 2019
Study Completion (ACTUAL)
January 10, 2020
Study Registration Dates
First Submitted
January 11, 2023
First Submitted That Met QC Criteria
January 19, 2023
First Posted (ACTUAL)
January 23, 2023
Study Record Updates
Last Update Posted (ESTIMATE)
February 9, 2023
Last Update Submitted That Met QC Criteria
February 6, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCEE2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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