Investigation of the Effect of Exercise Training on Psychosocial Outcomes in Rotator Cuff
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Constant-Murley Score
研究概览
简要总结
This study aimed to determine the psychosocial effects of exercise training in patients with rotator cuff tears.
详细描述
This study aimed to determine the psychosocial effects of exercise training in patients with rotator cuff tears. Fifty voluntary patients with partial rotator cuff tear will be randomized into two groups: Supervised exercise group (SE) and home exercise (HE) group, for a standardized 8 weeks exercise program. The primary outcome is the Constant-Murley Score (CMS). The secondary outcomes are the Visual Analogue Scale (VAS), active range of motion (AROM), Pain Catastrophizing Scale (PCS), Hospital Anxiety and Depression Scale (HADS), Pittsburgh Sleep Quality Index (PSI), Short Form-12 (SF-12), and Global Rating of Change (GRC). Outcome measures will be performed at baseline and at the end of 8-week intervention.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Forty years of age or older patients that have been diagnosed for a partial rotator cuff tear that is unrelated to trauma by a specialist orthopedist with MRI and physical examination and no other shoulder problems on the diagnosed shoulder will be included into this study.
排除标准
- •Patients diagnosed with full-thickness or massive rotator cuff tear, patients who undergone previous surgery, patients diagnosed with frozen shoulder or glenohumeral instability, and athletic patients younger than 40 years of age with symptoms of acute RC tear will not be included into this study.
研究组 & 干预措施
Supervised exercise group
The group received the supervised exercise program
干预措施: Supervised exercise program (Other)
Home exercise group
The group received the home exercise program
干预措施: Home exercise program (Diagnostic Test)
结局指标
主要结局
Constant-Murley Score
时间窗: Baseline
The functional level will be assessed by the Constant Murley Score, which is a 100-point scale consisting of 15 points for pain, 20 points for daily activities, 40 points for pain-free range of motion, and 25 points for strength. High scores are positively correlated with the increased functional level. While pain and activities of daily living are evaluated by the patient, range of motion and strength are evaluated by the clinician.
次要结局
- Visual Analogue Scale (VAS)(At the end of 8-week intervention)
- Pain Catastrophizing Scale (PCS)(At the end of the 8-week intervention)
- Short Form-12 (SF-12)(At the end of the 8-week intervention)
- Global Rating of Change (GRC)(At the end of the 8-week intervention)
- Exercise Dairy(At the end of the 8-week intervention)
- Active Range of Motion (AROM) Assessment(At the end of 8-week intervention)
- Constant-Murley Score(At the end of 8-week intervention)
- The Hospital Anxiety and Depression Scale (HADS)(At the end of the 8-week intervention)
- Pittsburgh Sleep Quality Index (PSQI)(At the end of the 8-week intervention)
研究者
Tansu Birinci
Principal Investigator
Istanbul University - Cerrahpasa