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

Overview

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

• Behavioral dietary 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.
• Behavioral Control
  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.

Primary outcome measures

• Knee Extensor Strength [Time frame: Week 12]

Secondary outcome measures (8)

• 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]

Eligibility criteria

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

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 40713590

Identifiers

NCT: NCT06937073 · WCHSCU-2024-2455

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗