Multi-component Real-time Remote Rehabilitation in Sarcopenia

Sichuan University

Status: Not yet enrolling

Conditions: Sarcopenia

Treatments: Behavioral: Control; Behavioral: dietary intake guidance and exercise guidance

Study type: Interventional

Funder types: Other

Identifiers

NCT06937073

WCHSCU-2024-2455

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 estimated patients

Sex: All

Ages: 60 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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104 participants in 2 patient groups

Arm 1

Experimental group

Description:

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.

Treatment:

Behavioral: dietary intake guidance and exercise guidance

Arm 2

Active Comparator group

Description:

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.

Treatment:

Behavioral: Control