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Respiratory and Physical Functions in Individuals With Chronic Venous Insufficiency

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06196541
Enrollment
60
Registered
2024-01-09
Start date
2023-12-27
Completion date
2026-07-27
Last updated
2026-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Venous Insufficiency

Keywords

edema, pain, venous insufficiency, quality of life, respiratory function tests, maximal respiratory pressures, exercise capacity

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. 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.

Interventions

None listed

Sponsors

Izmir Democracy University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Maximal inspiratory pressure (MIP)through study completion, an average of 1 yearThe 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)through study completion, an average of 1 yearThe 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

MeasureTime frameDescription
Total quality of life score evaluated by Chronic Venous Disease Quality of Life Questionnairethrough study completion, an average of 1 yearThe 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.
Forced vital capacity (FVC)through study completion, an average of 1 yearPulmonary function (Forced vital capacity (FVC) will be evaluated with a spirometer.
Forced expiratory volume in the first second (FEV1)through study completion, an average of 1 yearPulmonary function (Forced expiratory volume in the first second (FEV1) will be evaluated with a spirometer.
FEV1 / FVCthrough study completion, an average of 1 yearPulmonary function (FEV1 / FVC) will be evaluated with a spirometer.
The distance of six-minute walk testthrough study completion, an average of 1 yearThe six-minute walk test (6-MWT) will be performed according to the criteria of the American Thoracic Society for the evaluation of aerobic capacity.
Peak flow rate (PEF)through study completion, an average of 1 yearPulmonary function (Peak flow rate (PEF) will be evaluated with a spirometer.
edemathrough study completion, an average of 1 yearEdema in the lower extremity will be evaluated by measuring the circumference using a tape measure.
Pain Intensity measured with the Numerical Rating Scale.through study completion, an average of 1 yearPain 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).
Flow rate 25-75% of forced expiratory volume (FEF 25-75%)through study completion, an average of 1 yearPulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be evaluated with a spirometer.
Lower extremity strengththrough study completion, an average of 1 yearTo determine lower extremity strength and functional mobility, the 30-second Sit-Up Test will be used in the chair.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORECEM ÖZDEMİR

Dokuz Eylul University

PRINCIPAL_INVESTIGATOREMEK NAZIM EKER

Dokuz Eylul University

PRINCIPAL_INVESTIGATORANIL GİRGİN

Dokuz Eylul University

STUDY_DIRECTORGÜLŞAH BARĞI, Assoc. Dr.

Izmir Democracy University

PRINCIPAL_INVESTIGATORÖZLEM ÖZLEM ÇİNAR ÖZDEMİR, Assoc. Dr.

Izmir Democracy University

PRINCIPAL_INVESTIGATORCEMRE GÖRÜNMEZOĞLU, MSc

Izmir Democracy University

PRINCIPAL_INVESTIGATORSADIK KIVANÇ METİN, Prof. Dr.

Dokuz Eylul University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 21, 2026