Multi-component Real-time Remote Rehabilitation in Sarcopenia

NCT06937073 | Not Yet Recruiting DMC

• 1 other identifier: WCHSCU-2024-2455
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sarcopenia

Keywords

Sarcopenia; remote rehabilitation; muscle strength; real-time remote rehabilitation

Outcome Measures

Primary Outcomes (1)

• Knee Extensor Strength

  Measurement of the maximal isometric strength of the knee extensor muscles using a dynamometer. Assessed at week 12.

  Week 12

Secondary Outcomes (8)

• Knee Extensor Strength

  Week 6

• Knee Flexor Strength

  Weeks 6 and 12

• Grip Strength (Upper Limb Muscle Strength)

  Weeks 6 and 12

• Timed Up and Go Test (TUGT)

  Weeks 6 and 12

• 6-Meter Gait Speed Test

  Weeks 6 and 12

Study Arms (2)

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.

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.

Behavioral: Control

Interventions

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. 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 1

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.

Arm 2

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Jian Li, MM

  Sports Medicine Center, West China Hospital, Sichuan University

  STUDY DIRECTOR

Central Study Contacts

Linbo Peng, MD

CONTACT

+86 18615719526; penglinbo92@163.com

Kexin Wang, MM

CONTACT

+86 15881189695; wangkexin3@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Single center, non blinded, randomized controlled, dual arm trial

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 20, 2025
• Study Start: July 31, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 12 months after study completion
• Access Criteria: Request required, reviewed by PI