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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dietary intake guidance and exercise guidance | Behavioral | In the "Fugu Medical" WeChat mini program, the intervention plan for the intervention group included: (1) dietary intake guidance and (2) exercise guidance.
|
| Measure | Description | Time Frame |
|---|---|---|
| Knee Extensor Strength | Measurement of the maximal isometric strength of the knee extensor muscles using a dynamometer. Assessed at week 12. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Knee Extensor Strength | Same assessment as primary outcome but conducted at week 6. | 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. |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linbo Peng, MD | Contact | +86 18615719526 | penglinbo92@163.com | |
| Kexin Wang, MM | Contact | +86 15881189695 | wangkexin3@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Jian Li, MM | Sports Medicine Center, West China Hospital, Sichuan University | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40713590 | Derived | 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. |
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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.
12 months after study completion
Request required, reviewed by PI
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Single center, non blinded, randomized controlled, dual arm trial
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| Control | Behavioral | 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. |
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| 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. | 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. | 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. | 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. | 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. | 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 | weeks 6 and 12 |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |