SarcopeniaNCT06937073
Multi-component Real-time Remote Rehabilitation in Sarcopenia
A study testing dietary intake guidance and exercise guidance in people with Sarcopenia, run by West China Hospital.
Trial summary
This study is designed as a single center, non blinded, randomized controlled, dual arm trial. We designed to allocate participants in a 1:1 ratio to compare the effects of real-time remote rehabilitation and self rehabilitation with multiple components on muscle strength, muscle mass, balance, and walking ability in… Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Sarcopenia
- What is being tested?
- dietary intake guidance and exercise guidance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- According to the diagnostic criteria for sarcopenia established by the Asian Working Group for Sarcopenia (AWGS):
- Low muscle strength:
- Handgrip strength < 28 kg for men, < 18 kg for women; and/or
- Low physical performance:
- Usual gait speed (6-Meter Gait Speed, 6MGS) ≤ 1.0 m/s; and/or
- Low muscle mass:
- Skeletal Muscle Mass Index (SMI) < 7.0 kg/m² for men, < 5.7 kg/m² for women.
Who cannot join
- Unable or unwilling to undergo body composition measurement.
- Regular exercise habits within the past 6 months (resistance training ≥ 2 times/week, moderate-intensity aerobic exercise ≥ 3 times/week).
- History of unstable cardiovascular disease, stroke, diabetes, psychiatric disorders, or other contraindications to exercise in the past 6 months.
- Previously diagnosed with rheumatoid arthritis.
- History of conditions affecting motor coordination, such as poliomyelitis sequelae, epilepsy, or stroke sequelae.
- Presence of implanted medical devices due to previous fractures, heart disease, or other conditions.
- Diagnosis of malignant tumors.
- Unable to independently use the WeChat mini program used in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Study of Multi-component Real-time Remote Rehabilitation and Self Rehabilitation in the Treatment of Sarcopenia
This study is designed as a single center, non blinded, randomized controlled, dual arm trial. We designed to allocate participants in a 1:1 ratio to compare the effects of real-time remote rehabilitation and self rehabilitation with multiple components on muscle strength, muscle mass, balance, and walking ability in patients with sarcopenia. Each participant signs an informed consent form before registering for the study. This protocol follows the 2013 Standard Protocol Project: Intervention Trial Recommendation Guidelines.
Read the detailed description
This study is designed as a single center, non blinded, randomized controlled, dual arm trial. We designed to allocate participants in a 1:1 ratio to compare the effects of real-time remote rehabilitation and self rehabilitation with multiple components on muscle strength, muscle mass, balance, and walking ability in patients with sarcopenia. Each participant signs an informed consent form before registering for the study. This protocol follows the 2013 Standard Protocol Project: Intervention Trial Recommendation Guidelines.
- Conditions
- Sarcopenia
- Being tested
- dietary intake guidance and exercise guidance, Control
- Keywords
- Sarcopenia, remote rehabilitation, muscle strength, real-time remote rehabilitation
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary intake guidance and exercise guidanceBehavioural
In the "Fugu Medical" WeChat mini program, the intervention plan for the intervention group included: (1) dietary intake guidance and (2) exercise guidance.
- Dietary intake guidance: The dietary guidance was mainly based on the general dietary guidelines for the elderly issued by the Chinese Nutrition Society.
- Exercise guidance Exercise guidance included resistance training and balance training.
ControlBehavioural
Participants in the control group only received rehabilitation program articles in the form of images and text through the mobile application. These materials also included dietary intake guidance and exercise instructions. The frequency and intensity of the exercise instructions were sent to the patients at the same time. However, their daily adherence, including whether the training was completed or whether the dietary intake was appropriate, was not checked, verified, or followed up.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | In the "Fugu Medical" WeChat mini program, the intervention plan for the intervention group included: (1) dietary intake guidance and (2) exercise guidance. (1) Dietary intake guidance: The dietary guidance was mainly based on the general dietary guidelines for the elderly issued by the Chinese Nutrition Society. (2) Exercise guidance Exercise guidance included resistance training and balance training. Receives: Behavioral: dietary intake guidance and exercise guidance |
| Arm 2 | Active comparator | Participants in the control group only received rehabilitation program articles in the form of images and text through the mobile application. These materials also included dietary intake guidance and exercise instructions. The frequency and intensity of the exercise instructions were sent to the patients at the same time. However, their daily adherence, including whether the training was completed or whether the dietary intake was appropriate, was not checked, verified, or followed up. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Extensor Strength
Measurement of the maximal isometric strength of the knee extensor muscles using a dynamometer. Assessed at week 12.
Measured: Week 12
Secondary outcomes (8)
Knee Extensor Strength
Same assessment as primary outcome but conducted at week 6.
Measured: Week 6
Knee Flexor Strength
Measurement of the maximal isometric strength of the knee flexor muscles using a dynamometer. Assessed at weeks 6 and 12.
Measured: Weeks 6 and 12
Grip Strength (Upper Limb Muscle Strength)
Assessment of upper limb strength via handgrip dynamometry, using the dominant hand. Recorded at weeks 6 and 12.
Measured: Weeks 6 and 12
Timed Up and Go Test (TUGT)
A functional mobility test measuring the time (in seconds) it takes to stand up from a chair, walk 3 meters, turn around, walk back, and sit down. Evaluated at weeks 6 and 12.
Measured: Weeks 6 and 12
6-Meter Gait Speed Test
Assessment of walking speed over a 6-meter distance, used to evaluate lower limb mobility. Performed at weeks 6 and 12.
Measured: Weeks 6 and 12
6-Minute Walk Test (6MWT)
Measures the total distance (in meters) a participant can walk in 6 minutes to assess endurance. Conducted at weeks 6 and 12.
Measured: Weeks 6 and 12
Appendicular Skeletal Muscle Mass Index (ASMI)
Index of appendicular skeletal muscle mass (kg/m²), measured by bioelectrical impedance analysis or DXA. Evaluated at weeks 6 and 12.
Measured: Weeks 6 and 12
Reversal of Sarcopenia
The reversal of sarcopenia will be assessed based on the AWGS criteria. Participants who no longer meet the diagnostic thresholds for low muscle mass and either low muscle strength or physical performance at week 12 will be classified as having experienced sarcopenia reversal
Measured: weeks 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start31 Jul 2025 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single center, non blinded, randomized controlled, dual arm trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linbo Peng, West China Hospital
- Investigators
- Jian Li, MM, Study director, Sports Medicine Center, West China Hospital, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937073
- Sponsor's protocol ID
- WCHSCU-2024-2455
- Status last verified
- Jul 2025
- First submitted
- 17 Apr 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (such as outcome measures and adherence scores) will be made available upon reasonable request within 12 months after study completion. Data access will be granted for academic research purposes only, subject to review and approval by the principal investigator.
Publications
Wang K, Peng L, You M, Shen B, Li J. Real-time multicomponent remote rehabilitation versus self-rehabilitation for sarcopenia: a randomized controlled trial protocol. J Orthop Surg Res. 2025 Jul 25;20(1):701. doi: 10.1186/s13018-025-06124-0.
PubMed 40713590
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Multi-component Real-time Remote Rehabilitation and Self Rehabilitation in the Treatment of Sarcopenia
- ClinicalTrials.gov ID
- NCT06937073
- Acronym / sponsor ID
- WCHSCU-2024-2455
- Conditions
- Sarcopenia
- Keywords
- Sarcopenia, remote rehabilitation, muscle strength, real-time remote rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 31 Jul 2025 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Apr 2025 (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.
This study is designed as a single center, non blinded, randomized controlled, dual arm trial. We designed to allocate participants in a 1:1 ratio to compare the effects of real-time remote rehabilitation and self rehabilitation with multiple components on muscle strength, muscle mass, balance, and walking ability in patients with sarcopenia. Each participant signs an informed consent form before registering for the study. This protocol follows the 2013 Standard Protocol Project: Intervention Trial Recommendation Guidelines.
Detailed description
This study is designed as a single center, non blinded, randomized controlled, dual arm trial. We designed to allocate participants in a 1:1 ratio to compare the effects of real-time remote rehabilitation and self rehabilitation with multiple components on muscle strength, muscle mass, balance, and walking ability in patients with sarcopenia. Each participant signs an informed consent form before registering for the study. This protocol follows the 2013 Standard Protocol Project: Intervention Trial Recommendation Guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single center, non blinded, randomized controlled, dual arm trial
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: dietary intake guidance and exercise guidanceIn the "Fugu Medical" WeChat mini program, the intervention plan for the intervention group included: (1) dietary intake guidance and (2) exercise guidance. (1) Dietary intake guidance: The dietary guidance was mainly based on the general dietary guidelines for the elderly issued by the Chinese Nutrition Society. (2) Exercise guidance Exercise guidance included resistance training and balance training. |
| Arm 2 | Active comparator | Behavioral: ControlParticipants in the control group only received rehabilitation program articles in the form of images and text through the mobile application. These materials also included dietary intake guidance and exercise instructions. The frequency and intensity of the exercise instructions were sent to the patients at the same time. However, their daily adherence, including whether the training was completed or whether the dietary intake was appropriate, was not checked, verified, or followed up. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- According to the diagnostic criteria for sarcopenia established by the Asian Working Group for Sarcopenia (AWGS):
- Low muscle strength:
- Handgrip strength < 28 kg for men, < 18 kg for women; and/or
- Low physical performance:
- Usual gait speed (6-Meter Gait Speed, 6MGS) ≤ 1.0 m/s; and/or
Key exclusion criteria (8 listed)
- Unable or unwilling to undergo body composition measurement.
- Regular exercise habits within the past 6 months (resistance training ≥ 2 times/week, moderate-intensity aerobic exercise ≥ 3 times/week).
- History of unstable cardiovascular disease, stroke, diabetes, psychiatric disorders, or other contraindications to exercise in the past 6 months.
- Previously diagnosed with rheumatoid arthritis.
- History of conditions affecting motor coordination, such as poliomyelitis sequelae, epilepsy, or stroke sequelae.
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 |
|---|---|---|
| dietary intake guidance and exercise guidanceIn the "Fugu Medical" WeChat mini program, the intervention plan for the intervention group included: (1) dietary intake guidance and (2) exercise guidance. 1. Dietary intake guidance: The dietary guidance was mainly based on the general dietary guidelines for the elderly issued by the Chinese Nutrition Society. 2. Exercise guidance Exercise guidance included resistance training and balance training. | Behavioural | Arm 1 |
| ControlParticipants in the control group only received rehabilitation program articles in the form of images and text through the mobile application. These materials also included dietary intake guidance and exercise instructions. The frequency and intensity of the exercise instructions were sent to the patients at the same time. However, their daily adherence, including whether the training was completed or whether the dietary intake was appropriate, was not checked, verified, or followed up. | Behavioural | Arm 2 |
Primary outcome
Knee Extensor Strength
Time frame: Week 12
Measurement of the maximal isometric strength of the knee extensor muscles using a dynamometer. Assessed at week 12.
8 secondary outcomes
Knee Extensor Strength
Time frame: Week 6
Knee Flexor Strength
Time frame: Weeks 6 and 12
Grip Strength (Upper Limb Muscle Strength)
Time frame: Weeks 6 and 12
Timed Up and Go Test (TUGT)
Time frame: Weeks 6 and 12
6-Meter Gait Speed Test
Time frame: Weeks 6 and 12
6-Minute Walk Test (6MWT)
Time frame: Weeks 6 and 12
Appendicular Skeletal Muscle Mass Index (ASMI)
Time frame: Weeks 6 and 12
Reversal of Sarcopenia
Time frame: weeks 6 and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Derived from this study: PubMed 40713590Wang K, Peng L, You M, Shen B, Li J. Real-time multicomponent remote rehabilitation versus self-rehabilitation for sarcopenia: a randomized controlled trial protocol. J Orthop Surg Res. 2025 Jul 25;20(1):701. doi: 10.1186/s13018-025-06124-0.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (such as outcome measures and adherence scores) will be made available upon reasonable request within 12 months after study completion. Data access will be granted for academic research purposes only, subject to review and approval by the principal investigator.
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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.
Jian Li, MM study director
Sports Medicine Center, West China Hospital, Sichuan University
Questions about this trial
What is this clinical trial studying?
A study testing dietary intake guidance and exercise guidance in people with Sarcopenia, run by West China Hospital.
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 7 inclusion and 8 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: opening soon, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linbo Peng, MD (+86 18615719526, penglinbo92@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Extensor Strength (time frame: Week 12). 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 NCT06937073, which also lists 1 linked publication.
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 11 Jul 2025.