Blood Flow Restriction Training for Age-Related Sarcopenia

Официальное название

The Efficacy of Blood Flow Restriction Training in Elderly Patients With Sarcopenia.

Обзор

Brief Title: Safe Exercise for Age-Related Muscle Loss in Hospitalized Seniors Summary: This study compares two exercise methods to help older hospital patients (age 65+) rebuild muscle strength after being diagnosed with sarcopenia (age-related muscle loss). We want to know if using special pressure cuffs during light exercise works better than traditional strength training alone. Who Can Join: Hospitalized seniors with stable health conditions Excludes those with severe disabilities, dementia, or certain blood circulation problems What We'll Do: 40 participants will be randomly assigned to either: Traditional Training Group: Uses weights/bands at 65-75% max capacity Arm/leg exercises 3x/week for 4 weeks Pressure Cuff Training Group: Uses special cuffs on arms/thighs during lighter exercises (20% max capacity) Same exercise frequency with controlled pressure for safety What We'll Measure: Handgrip strength (main test at 0/4/12 weeks) Walking speed, balance tests, quality of life surveys Any side effects like dizziness/nausea Safety First: Doctors will check your health before starting. Nurses will monitor every session. We use medical-grade cuffs with safe pressure limits (arm: 80-100mmHg, thigh: 150-200mmHg). You can stop anytime if uncomfortable. Why This Matters: This could help hospitalized seniors regain strength faster using gentler exercises. All activities are supervised by rehabilitation specialists at West China Hospital, with ethics committee approval (IRB number required).

Вмешательства

• Устройство Blood Flow Restriction Training (BFRT)
  Standard progressive resistance exercise at 65-75% 1RM intensity using weights/elastic bands
• Другое Conventional Resistance Training (CRT)
  Standard progressive resistance exercise at 65-75% 1RM intensity using weights/elastic bands

Первичные конечные точки

• Change in Handgrip Strength [Срок оценки: Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 12)]

Вторичные конечные точки (4)

• 6-Meter Walking Speed [Срок оценки: Baseline (Week 0), Follow-up (Week 12)]
• Short Physical Performance Battery (SPPB) [Срок оценки: Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 12)]
• Timed Up and Go Test (TUG) [Срок оценки: Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 12)]
• MBI [Срок оценки: Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 12)]

Критерии участия

Критерии включения

• Hospitalized patients aged ≥65 years
• Diagnosed with sarcopenia per EWGSOP2019 criteria
• Acute medical conditions stabilized for ≥4 weeks (e.g., resolved infections, controlled heart failure)

Критерии исключения

• Severe disability (Barthel Index ≤40)
• Significant cognitive impairment (MMSE ≤18) or major psychiatric disorders (DSM-5 criteria)
• Contraindications to blood flow restriction training:

• History/predisposition to deep vein thrombosis
• Coagulopathy (INR >1.5, platelets <100×10⁹/L)
• Symptomatic varicose veins (CEAP class C4-C6)
• Uncontrolled hypertension (BP >160/100 mmHg)
• Chronic lymphedema (ISL stage II-III)
• Peripheral artery disease (ABI ≤0.7)
• Active systemic infection (CRP >10 mg/L)
• Malignancy (except non-melanoma skin cancer)
• Severe renal impairment (eGFR <30 mL/min/1.73m²)
• Acute coronary syndrome within 3 months

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.

Идентификаторы

NCT: NCT06986395 · 20241201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗