Comparison of the Efficacy of Active Versus Passive Methods in Patients With Chronic Venous Insufficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Circumference measurements
研究概览
简要总结
The aim of our study was to compare the effectiveness of active and passive practices in patients with CVI.
详细描述
Volunteers who have been diagnosed with venous insufficiency according to the criteria of inclusion, who applied to Cardiovascular Surgery Department will be included this study.
Participants will be randomly allocated 3 groups using the 'Research Randomizer' website. In all groups, a common evaluation protocol will be applied to the patients.
Compression therapy will be applied to the first group. Active treatment in addition to compression therapy will be applied to the second group. Passive treatment in addition to compression therapy will be applied to the third group.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of venous insufficiency with duplex ultrasonography
- •Classification of CEAP (Clinical-Etiological-Anatomical-Pathological) used in venous insufficiency is C3-C4-C5-C6
- •Ankle-brachial index (ABI) is less than 0.7
- •Possibility to communicate in written and verbal in Turkish
- •Have a level of cognitive ability to understand the instructions given
排除标准
- •Presence of deep vein thrombosis
- •Ulceration or open burn wound in lower extremity greater than 4 cm
- •Presence of infected ulceration
- •Cardiorespiratory insufficiency
- •Orthopedic, rheumatologic or neurological comorbidities restrain the exercise in the lower extremity
- •Presence of a psychiatric illness requiring the use of prescribed medicines
结局指标
主要结局
Circumference measurements
时间窗: Change from Baseline circumferences at 8 weeks.
Circumference measurements will be recorded at 4 cm intervals to evaluated to edema.
次要结局
- 6-Minute Walking Test(Assessment will be performed at baseline and at 8 weeks.)
- Visual Analogue Scale (VAS)(Assessment will be performed at baseline and at 8 weeks.)
- Handheld Dynamometer(Assessment will be performed at baseline and at 8 weeks.)
- Chronic Venous Disease Quality of Life Questionnaire (CIVIQ) 20(Assessment will be performed at baseline and at 8 weeks.)
- Venous Clinical Severity Score (VCSS)(Assessment will be performed tat baseline and at 8 weeks.)
- 10-Meter Walking Test(Assessment will be performed at baseline and at 8 weeks.)
研究者
Saliha Gürdal Karakelle
Research .Assistant
Istanbul University - Cerrahpasa (IUC)