Respiratory and Physical Functions in Individuals With Chronic Venous Insufficiency

NCT06196541 | Active Not Recruiting

• 1 other identifier: Chronic venous insufficiency
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Venous Insufficiency

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  through study completion, an average of 1 year

Secondary Outcomes (10)

• Pain Intensity measured with the Numerical Rating Scale.

  through study completion, an average of 1 year

• The distance of six-minute walk test

  through study completion, an average of 1 year

• Lower extremity strength

  through study completion, an average of 1 year

• Total quality of life score evaluated by Chronic Venous Disease Quality of Life Questionnaire

  through study completion, an average of 1 year

• Forced vital capacity (FVC)

  through study completion, an average of 1 year

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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
• years of age or older

You may not qualify if:

• 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
• years of age and older
• Volunteering to participate in the study
• Individuals who can understand and answer questionnaires and measurements
• Individuals with any physical or mental disability
• Individuals with any acute or chronic infection and/or health problems

Sponsors & Collaborators

• Izmir Democracy University: lead

Study Sites (1)

Izmir Democracy University

Izmir, 35140, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 11235498 BACKGROUND

• 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.

  PMID: 22682424 BACKGROUND

• 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.

  PMID: 35710091 BACKGROUND

MeSH Terms

Conditions

Edema; Pain; Venous Insufficiency

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Vascular Diseases; Cardiovascular Diseases

Study Officials

• GÜLŞAH BARĞI, Assoc. Dr.

  Izmir Democracy University

  STUDY DIRECTOR

• ÖZLEM ÖZLEM ÇİNAR ÖZDEMİR, Assoc. Dr.

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

• CEMRE GÖRÜNMEZOĞLU, MSc

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

• SADIK KIVANÇ METİN, Prof. Dr.

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

• ECEM ÖZDEMİR

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

• EMEK NAZIM EKER

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

• ANIL GİRGİN

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.

Study Record Dates

• First Submitted: December 24, 2023
• First Posted: January 9, 2024
• Study Start: December 27, 2023
• Primary Completion: December 27, 2025
• Study Completion (Estimated): December 27, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)