A Short-Bout Combined Aerobic and Resistance Exercise Program in Older Adults With Diabetes and Probable Sarcopenia

Официальное название

The Effect of a Short-Bout Combined Aerobic and Resistance Exercise Program on Physical Activity and Muscle Strength in Older Adults With Diabetes and Probable Sarcopenia: A Randomized Controlled Trial

Обзор

Older adults with diabetes are at high risk of developing sarcopenia. A preclinical stage, known as "probable sarcopenia" (defined by low muscle strength), represents a critical window for early intervention. Physical activity is an effective strategy, but many patients struggle to maintain regular exercise. This parallel-group randomized controlled trial aims to evaluate the effectiveness of a 12-week home-based, short-bout combined aerobic and resistance exercise program on physical activity level and muscle strength among older adults with diabetes and probable sarcopenia.

Подробное описание

The control group will receive usual community-based diabetes care. In addition to usual care, the intervention group will receive an individualized exercise program delivered in a short-bout, high-frequency format (resistance training: 3 days per week, three bouts per day at moderate intensity; aerobic training: 5 days per week, three bouts per day at moderate intensity). Primary outcomes are physical activity level and muscle strength. Assessments will be conducted at baseline, 12 weeks (post-intervention), and 24 weeks (follow-up).

Вмешательства

• Поведенческое Short-Bout Combined Exercise Program
  A 12-week home-based short-bout combined aerobic and resistance exercise program.

Первичные конечные точки

• Change in Physical Activity Level [Срок оценки: Baseline, 12 weeks, and 24 weeks]
• Change in Muscle Strength [Срок оценки: Baseline, 12 weeks, and 24 weeks]

Вторичные конечные точки (12)

• Change in Appendicular Skeletal Muscle Mass Index [Срок оценки: Baseline, 12 weeks, and 24 weeks]
• Change in Skeletal Muscle Mass [Срок оценки: Baseline, 12 weeks, and 24 weeks]
• Change in Physical Performance [Срок оценки: Baseline, 12 weeks, and 24 weeks]
• Reversal rate of probable sarcopenia [Срок оценки: Baseline, 12 weeks, and 24 weeks]
• Change in Glycated Hemoglobin [Срок оценки: Baseline, 12 weeks, and 24 weeks]
• Change in Fasting Plasma Glucose [Срок оценки: Baseline, 12 weeks, and 24 weeks]
• Change in Sarcopenia Awareness [Срок оценки: Baseline, 12 weeks, and 24 weeks]
• Change in Sarcopenia risk [Срок оценки: Baseline, 12 weeks, and 24 weeks]
• Change in Nutritional Status [Срок оценки: Baseline, 12 weeks, and 24 weeks]
• Change in Frailty Level [Срок оценки: Baseline, 12 weeks, and 24 weeks]
• Change in Fall risk [Срок оценки: Baseline, at 12 weeks post-intervention, and at 24 weeks post-intervention]
• Change in Depressive Symptoms [Срок оценки: Baseline, 12 weeks, and 24 weeks]

Критерии участия

Критерии включения

• Age ≥60 years, diagnosed with type 2 diabetes mellitus (T2DM) for ≥1 year.
• Meet the Asian Working Group for Sarcopenia (AWGS) 2025 criteria for probable sarcopenia.
• Physical activity <150 minutes per week of moderate-intensity aerobic activity.
• Conscious, able to communicate effectively in written or spoken language.
• Able to use a smartphone independently (or with minimal assistance).
• Voluntarily participate and provide written informed consent.

Критерии исключения

• Confirmed sarcopenia based on AWGS 2025.
• History or current diagnosis of psychiatric disorders, or severe cognitive impairment.
• Severe acute or chronic diabetic complications (e.g., diabetic ketoacidosis, proliferative diabetic retinopathy, stage IV-V diabetic nephropathy).
• Severe congestive heart failure (NYHA class III-IV), or acute cardiac event, syncope, or loss of consciousness within the past year.
• Severe pulmonary, hepatic, or renal insufficiency, or active malignancy.
• Concurrent participation in another exercise intervention study.
• Severe joint or muscle disease that strictly limits exercise (e.g., severe osteoarthritis, fracture, or other significant functional impairment), or other absolute contraindications to exercise.
• Unintentional weight change >5% or major changes in medication regimen within the 3 months prior to enrollment.
• Classified as poor health status (Group 3) according to the Chinese Guideline for the Prevention and Treatment of Type 2 Diabetes in the Elderly (2024 Edition).
• Implanted electronic medical device (e.g., cardiac pacemaker).

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

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07522359 · L2024SYSU-HL-057 · 2025A1515011403

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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