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NCT Number: NCT06937073

Multi-component Real-time Remote Rehabilitation in 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.

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Key information

Conditions

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

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

  • 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.

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.

Primary outcomes

  1. Knee Extensor Strength

    Time frame: Week 12

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

Secondary outcomes

  1. Knee Extensor Strength

    Time frame: Week 6

    Same assessment as primary outcome but conducted at week 6.

  2. Knee Flexor Strength

    Time frame: Weeks 6 and 12

    Measurement of the maximal isometric strength of the knee flexor muscles using a dynamometer. Assessed at weeks 6 and 12.

  3. Grip Strength (Upper Limb Muscle Strength)

    Time frame: Weeks 6 and 12

    Assessment of upper limb strength via handgrip dynamometry, using the dominant hand. Recorded at weeks 6 and 12.

  4. Timed Up and Go Test (TUGT)

    Time frame: Weeks 6 and 12

    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.

  5. 6-Meter Gait Speed Test

    Time frame: Weeks 6 and 12

    Assessment of walking speed over a 6-meter distance, used to evaluate lower limb mobility. Performed at weeks 6 and 12.

  6. 6-Minute Walk Test (6MWT)

    Time frame: Weeks 6 and 12

    Measures the total distance (in meters) a participant can walk in 6 minutes to assess endurance. Conducted at weeks 6 and 12.

  7. Appendicular Skeletal Muscle Mass Index (ASMI)

    Time frame: Weeks 6 and 12

    Index of appendicular skeletal muscle mass (kg/m²), measured by bioelectrical impedance analysis or DXA. Evaluated at weeks 6 and 12.

  8. Reversal of Sarcopenia

    Time frame: weeks 6 and 12

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Kexin Wang, MM

CONTACT

[email protected]

+86 15881189695

Linbo Peng, MD

CONTACT

[email protected]

+86 18615719526

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2025
Registry last updated
Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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