Multi-component Real-time Remote Rehabilitation in Sarcopenia

NCT ID: NCT06937073

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2026-12-31

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.

Conditions

Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

dietary intake guidance and exercise guidance

Intervention Type: 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 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.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Linbo Peng

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jian Li, MM

Role: STUDY_DIRECTOR

Sports Medicine Center, West China Hospital, Sichuan University

Central Contacts

Linbo Peng, MD

Role: CONTACT

penglinbo92@163.com

+86 18615719526

Kexin Wang, MM

Role: CONTACT

wangkexin3@qq.com

+86 15881189695

References

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.

Reference Type: DERIVED

PMID: 40713590 (View on PubMed)

Other Identifiers

WCHSCU-2024-2455

Identifier Type: -

Identifier Source: org_study_id