The Effect of Blood Flow Restriction Training on Muscle Thickness and Symptoms in Patients With Rotator Cuff Tendinopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Changes in shoulder muscle thickness and acromio-humeral distance
研究概览
简要总结
This study was planned to investigate the effect of blood flow restriction exercise training on shoulder muscle strength and muscle thickness, and to determine the change in pain and symptoms in patients with rotator cuff tendinopathy. Patients in the study group will perform the rehabilitation exercises with a pneumatic cuff and blood flow restricted. The patients in the control group will perform the same exercise program without restricting blood flow.
详细描述
In recent years, one of the popular applications used for muscle hypertrophy and strength training is low-intensity exercise training called Blood Flow Restriction Training. This exercise training has been shown to allow the benefits of high-intensity training at a much lower intensity. Given the light-load nature and strengthening capacity of this training, it can provide an effective clinical rehabilitation stimulus without the high levels of joint stress. It is suggested that it will be a useful exercise alternative especially in individuals who cannot tolerate high-intensity exercise. Especially patients with shoulder pain cannot tolerate high-intensity exercises in early rehabilitation.
This study was planned to investigate the effect of blood flow restriction exercise training on shoulder muscle strength and muscle thickness, and to determine the change in pain and symptoms in patients with rotator cuff tendinopathy.
Hypothesis 1: There is a difference between exercise training with blood flow restriction and exercise training without blood flow restriction in terms of muscle strength and muscle thickness.
Hypothesis 2: There is a difference between exercise training with blood flow restriction and exercise training without blood flow restriction in terms of shoulder pain and shoulder function.
The study was designed as a randomized-controlled. In order to provide an evenly equal number of individuals and homogeneous gender distribution in the groups blocking and stratification will be used as a randomization method. The sample size was calculated to be an 8% difference in muscle thickness at the end of treatment with 80% power and 5% type 1 error. A total of 26 patients were planned to be included in the study, including 13 volunteers in each group. Patients in the study group will perform the determined exercises with a pneumatic cuff and blood flow restricted. The patients in the control group will perform the same exercise program without restricting blood flow. Informed consent will be obtained from all individuals.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteer to participate in the study
- •Being 18-45 years
- •Unilateral rotator cuff related shoulder pain
- •No symptoms in the contralateral shoulder
排除标准
- •Diagnosis of hypertension, cardiovascular diseases, peripheral vascular diseases, deep vein thrombosis history, neurological diseases, systemic inflammation, obesity, diabetes
- •Subject has cancer
- •Pregnancy status
- •Cervical symptoms
- •Shoulder range of motion limitation
- •Injection to the shoulder joint in the last 6 months
- •Individuals who do not agree to participate in the study
结局指标
主要结局
Changes in shoulder muscle thickness and acromio-humeral distance
时间窗: baseline and 8 weeks
Ultrasonography measurement: supraspinatus, infraspinatus, deltoid, biceps, middle trapezius muscle thickness and acromio-humeral distance.
Changes in shoulder muscle strength
时间窗: baseline and 8 weeks
Isokinetic assesment: shoulder rotator muscle concentric strength at 60 º/sec and 180 º/sec speeds.
次要结局
- Changes in shoulder function(baseline and 8 weeks)
- Changes in shoulder pain: visual analogue scale(baseline and 8 weeks)
研究者
Dilara Kara
PhD candidate, Research assistant
Hacettepe University