Safety, Utility and Effects After 8 Weeks of High-intensity Strength Training With Blood Flow Restriction in the Rotator Cuff
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Isometric rotator cuff strength
研究概览
简要总结
This study aims to analyze the effects of an 8-week strength training program combining different exercise intensities and blood flow restriction (BFR) conditions on safety, tolerability, muscle adaptations, and physical performance variables. Three training modalities will be compared: 1) high-intensity exercise with BFR therapy; 2) low-intensity exercise with BFR therapy; and 3) high-intensity exercise without BFR therapy. All groups will perform the same exercise modality, differing only in intensity and the application of BFR.
Participants will be randomly assigned to one of the three groups and will undergo a 8-week intervention. The variables of interest will be assessed in each group for subsequent analysis and comparison.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, untrained adults
- •Age between 18 and 65
排除标准
- •Current participation in an upper limb strength training program
- •Presence of comorbidities that increase cardiovascular risk (uncontrolled ischemic heart disease, uncontrolled hypertension, diabetes, etc.)
- •Patients with more than one thromboembolism risk factor (obesity, history of thrombosis, prolonged immobilization, recent surgery, use of contraceptives, etc.)
- •Current diagnosis of any pathology affecting the cervical spine, shoulder, and/or thoracic spine
- •History of surgery in the last year
- •Use of ergogenic aids or medications that affect muscle metabolism (anabolic steroids, testosterone, creatine, protein supplements, corticosteroids, chronic use of nonsteroidal anti-inflammatory drugs, etc.)
研究组 & 干预措施
High-intensity exercise with blood occlusion
Sixteen sessions of exercise during 8 weeks, 70% repetition maximum, and 50% blood occlusion
干预措施: High-intensity exercise with BFR (Device)
Low-intensity exercise with blood occlusion
Sixteen sessions of exercise during 8 weeks, 30% repetition maximum, and 50% blood occlusion
干预措施: Low-intensity exercise with BFR (Device)
High-intensity exercise without blood occlusion
Sixteen sessions of exercise during 8 weeks, 70% repetition maximum, without blood occlusion
干预措施: High-intensity exercise without BFR (Procedure)
结局指标
主要结局
Isometric rotator cuff strength
时间窗: Baseline, 4 weeks and 8 weeks
Isometric rotator cuff strength measured with a dynamometer
Rate of perceived exertion
时间窗: Periprocedural
Rate of perceived exertion (RPE) measured using the Borg scale (0-10)
Perceived tolerance
时间窗: 8 weeks
Participant tolerance to the training protocol will be assessed at the end of the intervention using a 5-point Likert scale, ranging from very well tolerated (5), well tolerated (4), neutral (3), poorly tolerated (2), to very poorly tolerated (1).
Occurrence of adverse effects
时间窗: Immediately after the intervention, 1 hour, 6 hours, 24 hours, 1 week
Occurrence of adverse effects (e.g., pain, delayed onset muscle soreness, sudden weakness of the trained limb, redness or swelling of the trained limb, etc.) by self-report
Surface electromyography
时间窗: Periprocedural
Surface electromyography for the study of muscle recruitment (middle deltoid, infraspinatus, teres minor and trapezius muscles)
Muscle Thickness
时间窗: Baseline, 4 weeks, 8 weeks
Muscle thickness of the deltoid, biceps brachii, infraspinatus, supraspinatus and subescapularis will be assessed using ultrasound imaging
次要结局
未报告次要终点
研究者
Adrián Escriche Escuder
Assistant professor
University of Valencia