Sarcopenia
Conditions
Keywords
Sarcopenia, remote rehabilitation, muscle strength, real-time remote rehabilitation
Brief 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 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.
Interventions
BEHAVIORALdietary intake guidance and exercise guidance
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.
BEHAVIORALControl
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.
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Single center, non blinded, randomized controlled, dual arm trial
Eligibility
Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
According to the diagnostic criteria for sarcopenia established by the Asian Working Group for Sarcopenia (AWGS): 1. Low muscle strength: Handgrip strength \< 28 kg for men, \< 18 kg for women; and/or 2. Low physical performance: Usual gait speed (6-Meter Gait Speed, 6MGS) ≤ 1.0 m/s; and/or 3. Low muscle mass: Skeletal Muscle Mass Index (SMI) \< 7.0 kg/m² for men, \< 5.7 kg/m² for women.
Exclusion criteria
1. Unable or unwilling to undergo body composition measurement. 2. Regular exercise habits within the past 6 months (resistance training ≥ 2 times/week, moderate-intensity aerobic exercise ≥ 3 times/week). 3. History of unstable cardiovascular disease, stroke, diabetes, psychiatric disorders, or other contraindications to exercise in the past 6 months. 4. Previously diagnosed with rheumatoid arthritis. 5. History of conditions affecting motor coordination, such as poliomyelitis sequelae, epilepsy, or stroke sequelae. 6. Presence of implanted medical devices due to previous fractures, heart disease, or other conditions. 7. Diagnosis of malignant tumors. 8. Unable to independently use the WeChat mini program used in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Extensor Strength | Week 12 | Measurement of the maximal isometric strength of the knee extensor muscles using a dynamometer. Assessed at week 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Flexor Strength | Weeks 6 and 12 | Measurement of the maximal isometric strength of the knee flexor muscles using a dynamometer. Assessed at weeks 6 and 12. |
| Grip Strength (Upper Limb Muscle Strength) | Weeks 6 and 12 | Assessment of upper limb strength via handgrip dynamometry, using the dominant hand. Recorded at weeks 6 and 12. |
| Timed Up and Go Test (TUGT) | Weeks 6 and 12 | 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. |
| Knee Extensor Strength | Week 6 | Same assessment as primary outcome but conducted at week 6. |
| 6-Minute Walk Test (6MWT) | Weeks 6 and 12 | Measures the total distance (in meters) a participant can walk in 6 minutes to assess endurance. Conducted at weeks 6 and 12. |
| Appendicular Skeletal Muscle Mass Index (ASMI) | Weeks 6 and 12 | Index of appendicular skeletal muscle mass (kg/m²), measured by bioelectrical impedance analysis or DXA. Evaluated at weeks 6 and 12. |
| Reversal of Sarcopenia | weeks 6 and 12 | 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 |
| 6-Meter Gait Speed Test | Weeks 6 and 12 | Assessment of walking speed over a 6-meter distance, used to evaluate lower limb mobility. Performed at weeks 6 and 12. |
Contacts
Primary ContactLinbo Peng, MD
Backup ContactKexin Wang, MM
Outcome results
None listed