Respiratory and Physical Functions in Individuals With Chronic Venous Insufficiency (NCT06196541) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Respiratory and Physical Functions in Individuals With Chronic Venous Insufficiency
Turkey (Türkiye)60 participantsStarted 2023-12-27
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximal inspiratory pressure (MIP)
Timeframe: through study completion, an average of 1 year
2
Maximal expiratory pressure (MEP)
Timeframe: through study completion, an average of 1 year