The Efficacy of Blood Flow Restriction Training in Elderly Patients With Sarcopenia.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Change in Handgrip Strength
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
BFRT Group
"Blood flow restriction training with 20% 1RM loading, pneumatic cuff pressure 80-100mmHg (arms)
干预措施: Blood Flow Restriction Training (BFRT) (Device)
CRT Group
Conventional resistance training at 65-75% 1RM intensity using weights/elastic bands, matched frequency/duration
干预措施: Conventional Resistance Training (CRT) (Other)
结局指标
主要结局
Change in Handgrip Strength
时间窗: Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 12)
次要结局
- 6-Meter Walking Speed(Baseline (Week 0), Follow-up (Week 12))
- Short Physical Performance Battery (SPPB)(Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 12))
- Timed Up and Go Test (TUG)(Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 12))
- MBI(Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 12))
研究者
Yuxiang Liang
Physiotherapist-in-Charge
West China Hospital