Respiratory and Physical Functions in Individuals With Chronic Venous Insufficiency

May 16, 2025 updated by: Gulsah Bargi, Izmir Democracy University

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

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.

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İ̇zmi̇r, Turkey, 35140
        • Izmir Democracy University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Volunteer adult individuals diagnosed with chronic venous insufficiency by a Cardiovascular Specialist and healthy volunteer adult individuals without a diagnosis of chronic venous insufficiency will be included in this study.

Description

Inclusion criteria 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

Exclusion criteria 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
through study completion, an average of 1 year
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.
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity measured with the Numerical Rating Scale.
Time Frame: 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).
through study completion, an average of 1 year
The distance of six-minute walk test
Time Frame: 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.
through study completion, an average of 1 year
Lower extremity strength
Time Frame: 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.
through study completion, an average of 1 year
Total quality of life score evaluated by Chronic Venous Disease Quality of Life Questionnaire
Time Frame: 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.
through study completion, an average of 1 year
Forced vital capacity (FVC)
Time Frame: through study completion, an average of 1 year
Pulmonary function (Forced vital capacity (FVC) will be evaluated with a spirometer.
through study completion, an average of 1 year
Forced expiratory volume in the first second (FEV1)
Time Frame: through study completion, an average of 1 year
Pulmonary function (Forced expiratory volume in the first second (FEV1) will be evaluated with a spirometer.
through study completion, an average of 1 year
FEV1 / FVC
Time Frame: through study completion, an average of 1 year
Pulmonary function (FEV1 / FVC) will be evaluated with a spirometer.
through study completion, an average of 1 year
Flow rate 25-75% of forced expiratory volume (FEF 25-75%)
Time Frame: 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.
through study completion, an average of 1 year
Peak flow rate (PEF)
Time Frame: through study completion, an average of 1 year
Pulmonary function (Peak flow rate (PEF) will be evaluated with a spirometer.
through study completion, an average of 1 year
edema
Time Frame: through study completion, an average of 1 year
Edema in the lower extremity will be evaluated by measuring the circumference using a tape measure.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Democracy University

Investigators

  • Study Director: GÜLŞAH BARĞI, Assoc. Dr., Izmir Democracy University
  • Principal Investigator: CEMRE GÖRÜNMEZOĞLU, MSc, Izmir Democracy University
  • Principal Investigator: ÖZLEM ÖZLEM ÇİNAR ÖZDEMİR, Assoc. Dr., Izmir Democracy University
  • Principal Investigator: SADIK KIVANÇ METİN, Prof. Dr., Dokuz Eylül University
  • Principal Investigator: ECEM ÖZDEMİR, Dokuz Eylül University
  • Principal Investigator: EMEK NAZIM EKER, Dokuz Eylül University
  • Principal Investigator: ANIL GİRGİN, Dokuz Eylül University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 27, 2023

Primary Completion (Estimated)

December 27, 2025

Study Completion (Estimated)

December 27, 2026

Study Registration Dates

First Submitted

December 24, 2023

First Submitted That Met QC Criteria

December 24, 2023

First Posted (Actual)

January 9, 2024

Study Record Updates

Last Update Posted (Actual)

May 18, 2025

Last Update Submitted That Met QC Criteria

May 16, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Chronic venous insufficiency

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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