The Effectiveness of Exercise Training in Venous Insufficiency
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Chronic Venous Disease Quality of Life Questionnaire (CIVIQ) 20
研究概览
简要总结
The aim of this study is to evaluate the effects of exercise training in addition to compression therapy on clinical severity, vein diameter, reflux and quality of life in venous insufficiency patients.
详细描述
Volunteers who have been diagnosed with venous insufficiency according to the criteria of inclusion, who applied to Istanbul University Istanbul Medical Faculty Cardiovascular Surgery Department will be included this study.
Participants will be randomly allocated 2 groups using the 'Research Randomizer' website. In both groups, a common evaluation protocol will be applied to the patients.
Exercise training in addition to compression bandages will be applied to first group, compression bandages will be applied to second 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 lower extremity
- •Presence of a psychiatric illness requiring the use of prescribed medicines
结局指标
主要结局
Chronic Venous Disease Quality of Life Questionnaire (CIVIQ) 20
时间窗: Change from Baseline Quality of Life at 6 weeks.
CIVIQ 20 is a disease-related quality of life assessment form especially for chronic venous insufficiency patients. The total score is at least 0 and at most 100, and the higher scores indicate better quality of life.
次要结局
- Venous Clinical Severity Score (VCSS)(Assessment is performed at baseline and six weeks rehabilitation program.)
- The 6 Minute Walk Test(Assessment is performed at baseline and six weeks rehabilitation program.)
- Duplex Ultrasonography(Duplex Ultrasonography results is evaluated at baseline and six weeks rehabilitation program.)
- Measurement of Calf Girth(Assessment is performed at baseline and six weeks rehabilitation program.)
- 10-Meter Walk Test(Assessment is performed at baseline and six weeks rehabilitation program.)
- Assessment of Muscle Strength with Handheld Dynamometer(Assessment is performed at baseline and six weeks rehabilitation program.)
- Visual Analogue Scale (VAS)(Assessment is performed at baseline and six weeks rehabilitation program.)
- Short Form 36 (SF-36)(Assessment is performed before treatment and after six weeks rehabilitation program.)
研究者
Saliha Gürdal Karakelle
Research Assisstant
Istanbul University - Cerrahpasa