Respiratory and Physical Functions in Individuals With Chronic Venous Insufficiency
- Conditions
- Chronic Venous Insufficiency
- Registration Number
- NCT06196541
- Lead Sponsor
- Izmir Democracy University
- Brief Summary
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.
- Detailed Description
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. Fibrotic tissue formations in the lower extremity cause limitation in ankle movements. In a study by De Moura et al. it was found that walking speed, muscle strength and functional capacity levels of patients with chronic venous insufficiency were limited compared to healthy individuals. Venous function is reflected from venous return, venous resistance and its effects on cardiac output. Venous filling time is a parameter of venous function and is shortened as a result of valve insufficiency, vessel wall dilatation and muscle pump dysfunction. The calf muscles compress the deep intramuscular veins, directing blood flow from the veins to the heart. However, muscle pump dysfunction is not limited to the calf muscle but also includes inspiratory muscle dysfunction. It is known that the diaphragm creates a suction effect in the inferior vena cava during inspiration and expiration, allowing more blood flow from the lower extremities to the heart. The respiratory cycle has been shown to affect venous return in healthy individuals by increasing deep inspiration and the flow rate of the femoral vein. 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximal inspiratory pressure (MIP) 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) 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.
- Secondary Outcome Measures
Name Time Method Pain Intensity measured with the Numerical Rating Scale. through study completion, an average of 1 year Pain intensity will be measured with the Numerical Rating Scale. This scale expresses the severity of pain with integers from 0 (no pain) to 10 (the worst possible pain).
The distance of six-minute walk test through study completion, an average of 1 year The six-minute walk test (6-MWT) will be performed according to the criteria of the American Thoracic Society for the evaluation of aerobic capacity.
Lower extremity strength through study completion, an average of 1 year To determine lower extremity strength and functional mobility, the 30-second Sit-Up Test will be used in the chair.
Total quality of life score evaluated by Chronic Venous Disease Quality of Life Questionnaire through study completion, an average of 1 year The score will be evaluated using Chronic Venous Disease Quality of Life Questionnaire. Each question is scored on a 5-item Likert scale. Higher scores indicate better quality of life.
Peak flow rate (PEF) through study completion, an average of 1 year Pulmonary function (Peak flow rate (PEF) will be evaluated with a spirometer.
Forced vital capacity (FVC) through study completion, an average of 1 year Pulmonary function (Forced vital capacity (FVC) will be evaluated with a spirometer.
Forced expiratory volume in the first second (FEV1) through study completion, an average of 1 year Pulmonary function (Forced expiratory volume in the first second (FEV1) will be evaluated with a spirometer.
FEV1 / FVC through study completion, an average of 1 year Pulmonary function (FEV1 / FVC) will be evaluated with a spirometer.
Flow rate 25-75% of forced expiratory volume (FEF 25-75%) through study completion, an average of 1 year Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be evaluated with a spirometer.
edema through study completion, an average of 1 year Edema in the lower extremity will be evaluated by measuring the circumference using a tape measure.
Trial Locations
- Locations (1)
Izmir Democracy University
🇹🇷İ̇zmi̇r, Turkey