Multi-component Real-time Remote Rehabilitation in Sarcopenia

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Knee Extensor Strength [Срок оценки: Week 12]

Вторичные конечные точки (8)

• Knee Extensor Strength [Срок оценки: Week 6]
• Knee Flexor Strength [Срок оценки: Weeks 6 and 12]
• Grip Strength (Upper Limb Muscle Strength) [Срок оценки: Weeks 6 and 12]
• Timed Up and Go Test (TUGT) [Срок оценки: Weeks 6 and 12]
• 6-Meter Gait Speed Test [Срок оценки: Weeks 6 and 12]
• 6-Minute Walk Test (6MWT) [Срок оценки: Weeks 6 and 12]
• Appendicular Skeletal Muscle Mass Index (ASMI) [Срок оценки: Weeks 6 and 12]
• Reversal of Sarcopenia [Срок оценки: weeks 6 and 12]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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

Идентификаторы

NCT: NCT06937073 · WCHSCU-2024-2455

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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