Clinical trial NCT06937073: Multi-component Real-time Remote Rehabilitation in Sarcopenia
Official title: Comparative Study of Multi-component Real-time Remote Rehabilitation and Self Rehabilitation in the Treatment of Sarcopenia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sarcopenia
Keywords: Sarcopenia
remote rehabilitation
muscle strength
real-time remote rehabilitation
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 104
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center, non blinded, randomized controlled, dual arm trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Knee Extensor Strength
timeFrame: Week 12
Secondary outcomes:
measure: Knee Extensor Strength
timeFrame: Week 6
measure: Knee Flexor Strength
timeFrame: Weeks 6 and 12
measure: Grip Strength (Upper Limb Muscle Strength)
timeFrame: Weeks 6 and 12
measure: Timed Up and Go Test (TUGT)
timeFrame: Weeks 6 and 12
measure: 6-Meter Gait Speed Test
timeFrame: Weeks 6 and 12
measure: 6-Minute Walk Test (6MWT)
timeFrame: Weeks 6 and 12
measure: Appendicular Skeletal Muscle Mass Index (ASMI)
timeFrame: Weeks 6 and 12
Other outcomes:
Locations:
Study officials:
affiliation: Sports Medicine Center, West China Hospital, Sichuan University
name: Jian Li, MM
role: STUDY_DIRECTOR
References: