SarcopeniaNCT05694117
A Study of the Intervention Effect of a Hybrid Exercise Program on Elderly With Sarcopenia
A study testing self-determine sequence exercise program, resistance training and Taichi exercise and resistance training in people with Sarcopenia, run by Northeast Normal University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- self-determine sequence exercise program, resistance training and Taichi exercise and resistance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2019to 10 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Sarcopenia
- Being tested
- self-determine sequence exercise program, resistance training, Taichi exercise and resistance training, Randomly selected exercise program
- Keywords
- sarcopenia, elderly, exercise program, explainable artificial intelligence
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-determine sequence exercise programBehavioural
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).
resistance trainingBehavioural
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.
Taichi exercise and resistance trainingBehavioural
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).
Randomly selected exercise programBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| self-determine sequence exercise program | Experimental | 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 Receives: Behavioral: self-determine sequence exercise program |
| resistance training | Experimental | 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. Receives: Behavioral: resistance training |
| control group | No intervention | 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. |
| Taichi exercise and resistance training | Experimental | 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. Receives: Behavioral: Taichi exercise and resistance training |
| Randomly selected exercise program | Experimental | 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 Receives: Behavioral: Randomly selected exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Using quantitative CT to investigate the change of skeletal muscle area in sarcopenic elderly.
Participants will receive quantitative CT scans before and after the intervention to assess the change from baseline skeletal muscle area at 6 months.
Measured: Month 6
Using a Jamar hydraulic hand dynamometer to investigate change of handgrip in sarcopenic elderly.
Participants will receive a handgrip strength test before and after the intervention to assess the change from baseline handgrip strength at 6 months.
Measured: Month 6
Using a bioelectrical impedance body composition analyzer with a multifrequency device to investigate the change of relative skeletal muscle mass index in sarcopenic elderly.
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.
Measured: Month 6
Secondary outcomes (2)
Collect participants' self-evaluation of their life state and physical state.
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.
Measured: Month 6
Collect video of participants throughout the intervention.
The entire intervention process was videotaped and video of the entire intervention process was collected from the participants.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start20 Mar 2019
- Primary completion31 Dec 2019
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northeast Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guang Yang, Prof. Dr., Northeast Normal University
- Investigators
- Guang Yang, Study chair, Chinese Center of Exercise Epidemiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694117
- Sponsor's protocol ID
- CCEE2019
- Status last verified
- Feb 2023
- First submitted
- 11 Jan 2023
- Last updated
- 9 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wei M, He S, Meng D, Lv Z, Guo H, Yang G, Wang Z. White Box Modeling of Self-Determined Sequence Exercise Program Among Sarcopenic Older Adults: Uncovering a Novel Strategy Overcoming Decline of Skeletal Muscle Area. J Aging Phys Act. 2025 Jun 27;34(2):196-208. doi: 10.1123/japa.2024-0123. Print 2026 Apr 1.
PubMed 40581354Guo H, Cao J, He S, Wei M, Meng D, Yu I, Wang Z, Chang X, Yang G, Wang Z. Quantifying the Enhancement of Sarcopenic Skeletal Muscle Preservation Through a Hybrid Exercise Program: Randomized Controlled Trial. JMIR Aging. 2024 Nov 15;7:e58175. doi: 10.2196/58175.
PubMed 39621937He S, Wei M, Meng D, Wang Z, Yang G, Wang Z. Self-determined sequence exercise program for elderly with sarcopenia: A Randomized controlled trial with clinical assistance from explainable artificial intelligence. Arch Gerontol Geriatr. 2024 Apr;119:105317. doi: 10.1016/j.archger.2023.105317. Epub 2023 Dec 21.
PubMed 38176122
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- White Box Modeling of Self-Determine Sequence Exercise Program Among Sarcopenic Elderly: Uncovers a Novel Strategy Overcoming Decline of Skeletal Muscle Area
- ClinicalTrials.gov ID
- NCT05694117
- Acronym / sponsor ID
- CCEE2019
- Conditions
- Sarcopenia
- Keywords
- sarcopenia, elderly, exercise program, explainable artificial intelligence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Northeast Normal UniversityUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 23 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| self-determine sequence exercise program | Experimental | Behavioral: self-determine sequence exercise programThe 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 |
| resistance training | Experimental | Behavioral: resistance trainingResistance 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. |
| control group | No intervention | –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. |
| Taichi exercise and resistance training | Experimental | Behavioral: Taichi exercise and resistance trainingThe 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. |
| Randomly selected exercise program | Experimental | Behavioral: Randomly selected exercise programThe 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 |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| self-determine sequence exercise programThe 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). | Behavioural | self-determine sequence exercise program |
| resistance trainingThe 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. | Behavioural | resistance training |
| Taichi exercise and resistance trainingThe 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). | Behavioural | Taichi exercise and resistance training |
| Randomly selected exercise programParticipants 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). | Behavioural | Randomly selected exercise program |
Primary outcome
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.
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.
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.
2 secondary outcomes
Collect participants' self-evaluation of their life state and physical state.
Time frame: Month 6
Collect video of participants throughout the intervention.
Time frame: Month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Derived from this study: PubMed 40581354Wei M, He S, Meng D, Lv Z, Guo H, Yang G, Wang Z. White Box Modeling of Self-Determined Sequence Exercise Program Among Sarcopenic Older Adults: Uncovering a Novel Strategy Overcoming Decline of Skeletal Muscle Area. J Aging Phys Act. 2025 Jun 27;34(2):196-208. doi: 10.1123/japa.2024-0123. Print 2026 Apr 1.
- Derived from this study: PubMed 39621937Guo H, Cao J, He S, Wei M, Meng D, Yu I, Wang Z, Chang X, Yang G, Wang Z. Quantifying the Enhancement of Sarcopenic Skeletal Muscle Preservation Through a Hybrid Exercise Program: Randomized Controlled Trial. JMIR Aging. 2024 Nov 15;7:e58175. doi: 10.2196/58175.
- Derived from this study: PubMed 38176122He S, Wei M, Meng D, Wang Z, Yang G, Wang Z. Self-determined sequence exercise program for elderly with sarcopenia: A Randomized controlled trial with clinical assistance from explainable artificial intelligence. Arch Gerontol Geriatr. 2024 Apr;119:105317. doi: 10.1016/j.archger.2023.105317. Epub 2023 Dec 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guang Yang study chair
Chinese Center of Exercise Epidemiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-determine sequence exercise program, resistance training and Taichi exercise and resistance training in people with Sarcopenia, run by Northeast Normal University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Using quantitative CT to investigate the change of skeletal muscle area in sarcopenic elderly. (time frame: Month 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05694117, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.