Chronic Venous InsufficiencyNCT06196541
Respiratory and Physical Functions in Individuals With Chronic Venous Insufficiency
An observational study of Chronic Venous Insufficiency, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Venous Insufficiency
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Dec 2023to 27 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 18 years of age and older
- Volunteering to participate in the study
- Individuals who can understand and answer questionnaires and measurements
Who cannot join
- Individuals with any physical or mental disability
- Individuals with any acute or chronic infection and/or health problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Venous Insufficiency
- Keywords
- edema, pain, venous insufficiency, quality of life, respiratory function tests, maximal respiratory pressures, exercise capacity
- Medical subject headings
- Edema, Pain, Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Maximal inspiratory pressure (MIP)
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.
Measured: through study completion, an average of 1 year
Maximal expiratory pressure (MEP)
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (10)
Pain Intensity measured with the Numerical Rating Scale.
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).
Measured: through study completion, an average of 1 year
The distance of six-minute walk test
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.
Measured: through study completion, an average of 1 year
Lower extremity strength
To determine lower extremity strength and functional mobility, the 30-second Sit-Up Test will be used in the chair.
Measured: through study completion, an average of 1 year
Total quality of life score evaluated by Chronic Venous Disease Quality of Life Questionnaire
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.
Measured: through study completion, an average of 1 year
Forced vital capacity (FVC)
Pulmonary function (Forced vital capacity (FVC) will be evaluated with a spirometer.
Measured: through study completion, an average of 1 year
Forced expiratory volume in the first second (FEV1)
Pulmonary function (Forced expiratory volume in the first second (FEV1) will be evaluated with a spirometer.
Measured: through study completion, an average of 1 year
FEV1 / FVC
Pulmonary function (FEV1 / FVC) will be evaluated with a spirometer.
Measured: through study completion, an average of 1 year
Flow rate 25-75% of forced expiratory volume (FEF 25-75%)
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be evaluated with a spirometer.
Measured: through study completion, an average of 1 year
Peak flow rate (PEF)
Pulmonary function (Peak flow rate (PEF) will be evaluated with a spirometer.
Measured: through study completion, an average of 1 year
edema
Edema in the lower extremity will be evaluated by measuring the circumference using a tape measure.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start27 Dec 2023
- Primary completion27 Dec 2025
- Study completion27 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Venous InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulsah Bargi, Izmir Democracy University
- Investigators
- GÜLŞAH BARĞI, Assoc. Dr., Study director, Izmir Democracy UniversityÖZLEM ÖZLEM ÇİNAR ÖZDEMİR, Assoc. Dr., Principal investigator, Izmir Democracy UniversityCEMRE GÖRÜNMEZOĞLU, MSc, Principal investigator, Izmir Democracy UniversitySADIK KIVANÇ METİN, Prof. Dr., Principal investigator, Dokuz Eylul UniversityECEM ÖZDEMİR, Principal investigator, Dokuz Eylul UniversityEMEK NAZIM EKER, Principal investigator, Dokuz Eylul UniversityANIL GİRGİN, Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06196541
- Sponsor's protocol ID
- Chronic venous insufficiency
- Status last verified
- Aug 2026
- First submitted
- 24 Dec 2023
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kunimoto B, Cooling M, Gulliver W, Houghton P, Orsted H, Sibbald RG. Best practices for the prevention and treatment of venous leg ulcers. Ostomy Wound Manage. 2001 Feb;47(2):34-46, 48-50.
PubMed 11235498de Moura RM, Gomes Hde A, da Silva SL, Britto RR, Dias RC. Analysis of the physical and functional parameters of older adults with chronic venous disease. Arch Gerontol Geriatr. 2012 Nov-Dec;55(3):696-701. doi: 10.1016/j.archger.2012.05.005. Epub 2012 Jun 7.
PubMed 22682424Aydin G, Yeldan I, Akgul A, Ipek G. Effects of inspiratory muscle training versus calf muscle training on quality of life, pain, venous function and activity in patients with chronic venous insufficiency. J Vasc Surg Venous Lymphat Disord. 2022 Sep;10(5):1137-1146. doi: 10.1016/j.jvsv.2022.04.012. Epub 2022 Jun 14.
PubMed 35710091
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Edema, Pain, Respiratory Functions, Physical Functions and Quality of Life in Individuals With Chronic Venous Insufficiency
- ClinicalTrials.gov ID
- NCT06196541
- Acronym / sponsor ID
- Chronic venous insufficiency
- Conditions
- Chronic Venous Insufficiency
- Keywords
- edema, pain, venous insufficiency, quality of life, respiratory function tests, maximal respiratory pressures, exercise capacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- 27 Dec 2025 (actual)
- Study completion
- 27 Jul 2026 (actual)
- First posted
- 9 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 18 years of age and older
- Volunteering to participate in the study
- Individuals who can understand and answer questionnaires and measurements
Key exclusion criteria (2 listed)
- Individuals with any physical or mental disability
- Individuals with any acute or chronic infection and/or health problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
10 secondary outcomes
Pain Intensity measured with the Numerical Rating Scale.
Time frame: 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
Lower extremity strength
Time frame: 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
Forced vital capacity (FVC)
Time frame: 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
FEV1 / FVC
Time frame: 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
Peak flow rate (PEF)
Time frame: through study completion, an average of 1 year
edema
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Background: PubMed 11235498Kunimoto B, Cooling M, Gulliver W, Houghton P, Orsted H, Sibbald RG. Best practices for the prevention and treatment of venous leg ulcers. Ostomy Wound Manage. 2001 Feb;47(2):34-46, 48-50.
- Background: PubMed 22682424de Moura RM, Gomes Hde A, da Silva SL, Britto RR, Dias RC. Analysis of the physical and functional parameters of older adults with chronic venous disease. Arch Gerontol Geriatr. 2012 Nov-Dec;55(3):696-701. doi: 10.1016/j.archger.2012.05.005. Epub 2012 Jun 7.
- Background: PubMed 35710091Aydin G, Yeldan I, Akgul A, Ipek G. Effects of inspiratory muscle training versus calf muscle training on quality of life, pain, venous function and activity in patients with chronic venous insufficiency. J Vasc Surg Venous Lymphat Disord. 2022 Sep;10(5):1137-1146. doi: 10.1016/j.jvsv.2022.04.012. Epub 2022 Jun 14.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GÜLŞAH BARĞI, Assoc. Dr. study director
Izmir Democracy University
ÖZLEM ÖZLEM ÇİNAR ÖZDEMİR, Assoc. Dr. principal investigator
Izmir Democracy University
CEMRE GÖRÜNMEZOĞLU, MSc principal investigator
Izmir Democracy University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Venous Insufficiency, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal inspiratory pressure (MIP) (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06196541, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.