Respiratory and Physical Functions in Individuals With Chronic Venous Insufficiency

August 18, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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. 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: ÖZLEM ÖZLEM ÇİNAR ÖZDEMİR, Assoc. Dr.
  • Phone Number: +90 232 299 0733
  • Email: ozlem.cinar@idu.edu.tr

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Izmir Democracy University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 Eylul University
  • Principal Investigator: ECEM ÖZDEMİR, Dokuz Eylul University
  • Principal Investigator: EMEK NAZIM EKER, Dokuz Eylul University
  • Principal Investigator: ANIL GİRGİN, Dokuz Eylul 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 27, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 27, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 27, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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