Inspiratory Muscle Training Versus Calf Muscle on Venous Function in Patients With Chronic Venous Insufficiency
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- The Chronic Venous Insufficiency Questionnaire-20 (CIVIQ-20)
研究概览
简要总结
The aim of this study was to evaluate the effect of exercise training in addition to compression therapy on quality of life, venous return time, muscle strength, clinical severity, functional capacity in venous insufficiency compared to compression treatment alone. Fourty-two volunteer patients with venous insufficiency will include in the study were randomly divided into three groups as inspiratory exercise, calf muscle exercise and control. While the control group will receive only compression therapy, the inspiratory exercise group will apply inspiratory muscle training consisted of strengthening exercise in addition to compression therapy; kalf muscle exercise group will apply strengthening exercise for calf muscle in addition to compression therapy for 2 days/week with physiotherapist and 3 days/week by themselves, 8 weeks. All the patients will assess with Chronic Venous Disease Quality of life Questionnaire-20 (CIVIQ-20), Nottingham Health Profile, Photopletismograph, Venous Clinical Severity Score (VCSS), hand-held dynamometer, Visual Analogue Scale (VAS), circumference measurements, 6-minute walk test (6MWT), before and after the treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of venous insufficiency between 18-75 years with duplex ultrasound imaging
- •CEAP classification used in venous insufficiency is C2-C3-C4-C5
- •Having written and verbal communication in Turkish
排除标准
- •Acute deep vein thrombosis
- •The presence of ulceration
- •Being in class III and IV according to the New York Heart Association classification
- •Presence of respiratory failure
- •Undergoing chemotherapy due to the presence of any cancer
- •Being in the process of treatment for neurological, orthopedic or rheumatologic diseases including lower extremity
研究组 & 干预措施
Calf muscle training group
干预措施: exercise therapy (Other)
Control
İnspiratory muscle training group
干预措施: exercise therapy (Other)
结局指标
主要结局
The Chronic Venous Insufficiency Questionnaire-20 (CIVIQ-20)
时间窗: 12 months
Quality of life
Photoplethysmograph (PPG)
时间窗: 12 months
venous return time
次要结局
- digital goniometer(12 months)
- Hand held dynamometer(12 months)
- visual analog scale(12 months)
- Venous Clinical Severity Score (VCSS)(12 months)
- 6 minutes walk test(12 months)
研究者
Gamze Aydin
Principal İnvestigator
Istanbul University - Cerrahpasa (IUC)