Multi-component Real-time Remote Rehabilitation in Sarcopenia

Comparative Study of Multi-component Real-time Remote Rehabilitation and Self Rehabilitation in the Treatment of Sarcopenia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sarcopenia
• Intervention / Treatment: Behavioral: dietary intake guidance and exercise guidance; Behavioral: Control

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.

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kexin Wang, MM; Phone Number: +86 15881189695; Email: wangkexin3@qq.com
• Study Contact Backup: Name: Linbo Peng, MD; Phone Number: +86 18615719526; Email: penglinbo92@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; 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; In the "Fugu Medical" WeChat mini program, the intervention plan for the intervention group included: (1) dietary intake guidance and (2) exercise guidance.; Dietary intake guidance: The dietary guidance was mainly based on the general dietary guidelines for the elderly issued by the Chinese Nutrition Society.; Exercise guidance Exercise guidance included resistance training and balance training.
Active Comparator: Arm 2; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: West China Hospital
• Investigators: Study Director: Jian Li, MM, Sports Medicine Center, West China Hospital, Sichuan University

Study record dates

Study Major Dates

• Study Start (Estimated): July 31, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 17, 2025
• First Submitted That Met QC Criteria: April 17, 2025
• First Posted (Actual): April 20, 2025

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: July 7, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: muscle strength; Sarcopenia; remote rehabilitation; real-time remote rehabilitation
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: WCHSCU-2024-2455

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 12 months after study completion
• IPD Sharing Access Criteria: Request required, reviewed by PI
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No