Blood Flow Restrictive Exercise Application in the Treatment of Subacromial Impingement Syndrome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Shoulder ROM
研究概览
简要总结
Individuals diagnosed with Subacromial Impingement Syndrome by a physical therapist based on MRI results and examination findings will be included in the study. 40 people will be randomly divided into blood flow restrictive exercise (BFRT) and structured exercise program (SEP) groups, 20 people in each group. Participants will receive two evaluations: before starting treatment and immediately after 4 weeks of treatment. Pain, shoulder ROM, shoulder functional level, quality of life, shoulder muscle strength, grip strength, and sleep quality evaluation will be performed. The treatment program will be 5 days a week for a total of 4 weeks. The treatment will be individualized by calculating the appropriate resistance loads for the exercise program. All participants will undergo progressive exercises in sessions conducted by a physiotherapist.
详细描述
The study is planned to be carried out between September 2023 and June 2024. Individuals diagnosed with Subacromial Impingement Syndrome by a physical therapist based on MRI results and examination findings will be included in the study. The sample size of this study was calculated using G-Power 3.1.9.7. Assuming that effect sizes (ES) are 0.99, significance level (a) is 0.05, and statistical power (1-b) is 0.8, a minimum of 36 participants in total are required for this study. Considering the 10% dropout rate, it is planned to include 40 people in our study. The 40 people included will be randomly divided into blood flow restrictive exercise (BFRT) and structured exercise program (SEP) groups, with 20 people in each group. Randomization will be generated using the random number sequence www.random.org.
Criteria for Inclusion in the Study
- Being Volunteer
- Being between the ages of 25-65
- Being diagnosed with Stage 2 or 3 Subacromial Impingement Syndrome
- Not having had a steroid injection in the last 6 months
Exclusion Criteria from the Study
- Having neuromuscular disease
- History of upper extremity fracture
- Cardiovascular diseases
- Rheumatic diseases
- Having had shoulder, neck, elbow or hand surgery
- Presence of acute inflammation
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
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Individuals between the ages of 25-65
- •Being diagnosed with Stage 2 or 3 Subacromial Impingement Syndrome
- •Not having had a steroid injection in the last 6 months
排除标准
- •Having neuromuscular disease
- •History of upper extremity fracture
- •Cardiovascular diseases
- •Rheumatic diseases
- •Having had shoulder, neck, elbow or hand surgery
- •Presence of acute inflammation
研究组 & 干预措施
SEP Group
The treatment will be individualized by calculating the appropriate resistance loads for the exercise program. All participants will undergo progressive exercises in sessions conducted by a physiotherapist.
干预措施: Progressive Exercises (Other)
BFRT Group
People in the BFRT categories will perform the exercise program at approximately 20-30% resistance of 1-RM, and an upper arm reinforcement occlusion cuff will be used during strengthening exercises with dumbbells for the rotator cuff and scapula girdles
干预措施: Progressive Exercises (Other)
BFRT Group
People in the BFRT categories will perform the exercise program at approximately 20-30% resistance of 1-RM, and an upper arm reinforcement occlusion cuff will be used during strengthening exercises with dumbbells for the rotator cuff and scapula girdles
干预措施: Blood Flow Restriction Therapy (Other)
结局指标
主要结局
Shoulder ROM
时间窗: 4 weeks
Shoulder ROM was questioned with the Universal Goniometer. Shoulder flexion, abduction, internal and external range of motion of the individuals in the supine position will be evaluated as active and passive.
Pain İntensity
时间窗: 4 weeks
The severity shoulder pain was questioned with the Visual Anolog Scale (VAS). The assessment was based on a horizontal 10 cm scale from 1 (least pain) to 10 (the worst pain ever)
次要结局
- Shoulder Functional Level Assessment(4 weeks)
- Grip Strength Assessment(4 weeks)
- Quality of Life Assessment(4 weeks)
- Sleep Quality Assessment(4 weeks)
- Shoulder Muscle Strength Assessment(4 weeks)
研究者
Nursena Cansabuncu
MSc candidate
Medipol University