Respiratory and Physical Functions in Individuals With Chronic Venous Insufficiency

NCT ID: NCT06196541

Last Updated: 2025-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-27

Study Completion Date

2026-12-27

Brief Summary

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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

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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.

Conditions

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Chronic Venous Insufficiency

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Individuals with Chronic Venous Insufficiency

Edema, pain, respiratory functions, physical functions and quality of life will be evaluated in individuals with chronic venous insufficiency.

No interventions assigned to this group

Asymptomatic Healthy Individuals

Edema, pain, respiratory functions, physical functions and quality of life will be evaluated in asymptomatic healthy individuals.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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


* 18 years of age and older
* Volunteering to participate in the study
* Individuals who can understand and answer questionnaires and measurements

Exclusion Criteria

* 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


* Individuals with any physical or mental disability
* Individuals with any acute or chronic infection and/or health problems
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Izmir Democracy University

OTHER

Sponsor Role lead

Responsible Party

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Gulsah Bargi

Assoc.Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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GÜLŞAH BARĞI, Assoc. Dr.

Role: STUDY_DIRECTOR

Izmir Democracy University

ÖZLEM ÖZLEM ÇİNAR ÖZDEMİR, Assoc. Dr.

Role: PRINCIPAL_INVESTIGATOR

Izmir Democracy University

CEMRE GÖRÜNMEZOĞLU, MSc

Role: PRINCIPAL_INVESTIGATOR

Izmir Democracy University

SADIK KIVANÇ METİN, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Dokuz Eylul University

ECEM ÖZDEMİR

Role: PRINCIPAL_INVESTIGATOR

Dokuz Eylul University

EMEK NAZIM EKER

Role: PRINCIPAL_INVESTIGATOR

Dokuz Eylul University

ANIL GİRGİN

Role: PRINCIPAL_INVESTIGATOR

Dokuz Eylul University

Locations

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Izmir Democracy University

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 11235498 (View on PubMed)

de 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.

Reference Type BACKGROUND
PMID: 22682424 (View on PubMed)

Aydin 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.

Reference Type BACKGROUND
PMID: 35710091 (View on PubMed)

Other Identifiers

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Chronic venous insufficiency

Identifier Type: -

Identifier Source: org_study_id

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