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Clinical Trials/NCT06196541
NCT06196541
Active, not recruiting
Not Applicable

Edema, Pain, Respiratory Functions, Physical Functions and Quality of Life in Individuals With Chronic Venous Insufficiency

Izmir Democracy University1 site in 1 country60 target enrollmentDecember 27, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Venous Insufficiency
Sponsor
Izmir Democracy University
Enrollment
60
Locations
1
Primary Endpoint
Maximal inspiratory pressure (MIP)
Status
Active, not recruiting
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 27, 2023
End Date
December 27, 2026
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Izmir Democracy University
Responsible Party
Principal Investigator
Principal Investigator

Gulsah Bargi

Assoc.Prof.

Izmir Democracy University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Maximal inspiratory pressure (MIP)

Time Frame: 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)

Time Frame: 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 Outcomes

  • 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)

Study Sites (1)

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