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NCT Number: NCT06196541

Respiratory and Physical Functions 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Izmir Democracy University

Izmir, 35140, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. FEV1 / FVC

    Time frame: through study completion, an average of 1 year

    Pulmonary function (FEV1 / FVC) will be evaluated with a spirometer.

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

Izmir Democracy University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jan 9, 2024
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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