Edema, Pain, Respiratory Functions, Physical Functions and Quality of Life in Individuals 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
- 60
- 试验地点
- 2
- 主要终点
- Maximal inspiratory pressure (MIP)
研究概览
简要总结
In the literature, it is still unclear whether individuals with chronic venous insufficiency are affected by edema, pain, respiratory muscle strength, respiratory functions, functional capacity, lower extremity strength and quality of life compared to asymptomatic healthy individuals and if there is a deterioration in these parameters, its level is still unclear. For this reason, in this study it was aimed to investigate edema, pain, respiratory muscle strength, respiratory function, functional capacity, lower extremity strength and quality of life in individuals with chronic venous insufficiency and asymptomatic healthy individuals and to compare these parameters between the two groups.
详细描述
Chronic Venous Insufficiency affects approximately 30% of the global population and its main symptoms are pain, edema, throbbing, feeling of heaviness in the extremities, itching, varicose veins and tissue changes. Pain in CVI is a chronic condition that negatively affects the quality of life due to physical function and limitation of movement. Limitation of ankle movement in CVI is one of the factors that increase edema and venous severity. Researches investigating pulmonary function in chronic venous insufficiency are very limited. For this reason, in this study it was aimed to investigate edema, pain, respiratory muscle strength, respiratory function, functional capacity, lower extremity strength and quality of life in individuals with chronic venous insufficiency and asymptomatic healthy individuals and to compare these parameters between the two groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for individuals with chronic venous insufficiency:
- •Being diagnosed with chronic venous insufficiency
- •Being in one of the C1, C2, C3, C4, C5 stages according to the 'Clinical, Etiologic, Anatomic, Pathophysiologic' (CEAP) scale
- •Volunteering to participate in the study
- •18 years of age or older
排除标准
- •for individuals with chronic venous insufficiency:
- •Presence of arterial disease,
- •The presence of advanced cardiorespiratory diseases,
- •Orthopaedic and neurological disorders affecting walking,
- •Presence of acute ulcers (< 3 months) and diabetic ulcers,
- •Being pregnant.
- •History of deep vein thrombosis,
- •Presence of active infection
- •Inclusion criteria for asymptomatic healthy individuals:
- •18 years of age and older
- •Volunteering to participate in the study
- •Individuals who can understand and answer questionnaires and measurements
- •Exclusion criteria for asymptomatic healthy individuals:
- •Individuals with any physical or mental disability
- •Individuals with any acute or chronic infection and/or health problems
研究组 & 干预措施
Individuals with Chronic Venous Insufficiency
Edema, pain, respiratory functions, physical functions and quality of life will be evaluated in individuals with chronic venous insufficiency.
Asymptomatic Healthy Individuals
Edema, pain, respiratory functions, physical functions and quality of life will be evaluated in asymptomatic healthy individuals.
结局指标
主要结局
Maximal inspiratory pressure (MIP)
时间窗: through study completion, an average of 1 year
The MIP which shows respiratory muscle strength will be evaluated using a portable mouth pressure measuring device based on American Thoracic Society and European Respiratory Society criteria.
Maximal expiratory pressure (MEP)
时间窗: through study completion, an average of 1 year
The MEP which shows respiratory muscle strength will be evaluated using a portable mouth pressure measuring device based on American Thoracic Society and European Respiratory Society criteria.
次要结局
- Pain Intensity measured with the Numerical Rating Scale.(through study completion, an average of 1 year)
- The distance of six-minute walk test(through study completion, an average of 1 year)
- Lower extremity strength(through study completion, an average of 1 year)
- Total quality of life score evaluated by Chronic Venous Disease Quality of Life Questionnaire(through study completion, an average of 1 year)
- Peak flow rate (PEF)(through study completion, an average of 1 year)
- Forced vital capacity (FVC)(through study completion, an average of 1 year)
- Forced expiratory volume in the first second (FEV1)(through study completion, an average of 1 year)
- FEV1 / FVC(through study completion, an average of 1 year)
- Flow rate 25-75% of forced expiratory volume (FEF 25-75%)(through study completion, an average of 1 year)
- edema(through study completion, an average of 1 year)
研究者
Gulsah Bargi
Assoc.Prof.
Izmir Democracy University