Respiratory Functions, Aerobic Capacity and Quality of Life in Chronic Venous Insufficiency

NCT06785805 | Completed

• 1 other identifier: IzmirDemocracy University
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to retrospectively examine the dataset obtained from a previously conducted study titled 'Inspiratory muscle training in individuals with chronic venous insufficiency: randomized controlled trial'. The previously conducted study was a study investigating the effectiveness of the application, and the current study aims to clarify the gap in the literature with the relationship between the data obtained from the patients at the beginning of that study. This study will be conducted by re-examining the initial data of another study from which data was collected before and conducting new analyses. H0: There is no relationship between disease severity, edema, pain, respiratory muscle strength, respiratory functions, aerobic capacity, lower extremity strength or quality of life in individuals with chronic venous insufficiency. H1: There is a relationship between disease severity, edema, pain, respiratory muscle strength, respiratory functions, aerobic capacity, lower extremity strength or quality of life in individuals with chronic venous insufficiency.

Conditions

Chronic Venous Insufficiency, CVI

Keywords

disease severity; chronic venous insufficiency; respiratory functions

Outcome Measures

Primary Outcomes (1)

• Disease severity

  The disease severity (CEAP scores) of the individuals referred to the study were determined by the cardiovascular surgeon.

  From July 2023 to May 2024

Secondary Outcomes (7)

• Evaluation of Lower Extremity Strength

  From July 2023 to May 2024

• Assessment of aerobic capacity

  From July 2023 to May 2024

• Evaluation of respiratory functions

  From July 2023 to May 2024

• Respiratory muscle strength assessment

  From July 2023 to May 2024

• Quality of life assessment

  From July 2023 to May 2024

Study Arms (1)

Individuals with Chronic venous insufficiency

Our prospective randomized controlled planned study named 'Inspiratory Muscle Training in Individuals with Chronic Venous Insufficiency: Randomized Controlled Study', which was approved by Izmir Democracy University Non-Interventional Clinical Research Ethics Committee on 21/06/2023 with the decision number 2023/08-02, was conducted. Although 38 individuals diagnosed with CVI were included in the study, the study was completed with 30 individuals diagnosed with CVI who could complete the 6-week follow-up. In the current study, which is a continuation of the previsious research; It is aimed to analyze the initial measurement results of 38 individuals diagnosed with CVI who were initially included in the study and to contribute these data to the literature with a retrospective cross-sectional study design. Our new hypothesis is based on the examination of the correlation between these initial outcome measurements obtained from our previous study.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals diagnosed with chronic venous insufficiency volunteered to participate in the study

You may qualify if:

• Being diagnosed with chronic venous insufficiency
• Agreeing to participate in the study
• Being 18 years of age or older

You may not qualify if:

• Presence of arterial diseases
• Presence of advanced cardiorespiratory diseases
• Presence of acute ulcers (\< 3 months) and diabetic ulcers
• Being pregnant
• Presence of deep vein thrombosis
• Presence of active infection

Sponsors & Collaborators

• Izmir Democracy University: lead

Study Sites (1)

Izmir Democracy University

Izmir, Karabağlar/İzmir, 35140, Turkey (Türkiye)

Location

Related Publications (5)

• American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.

  PMID: 12186831 BACKGROUND

• Ozdemir OC, Tonga E, Tekindal A, Bakar Y. Cross-cultural adaptation, reliability and validity of the Turkish version of the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20). Springerplus. 2016 Mar 31;5:381. doi: 10.1186/s40064-016-2039-2. eCollection 2016.

  PMID: 27066388 BACKGROUND

• Kwon OY, Jung DY, Kim Y, Cho SH, Yi CH. Effects of ankle exercise combined with deep breathing on blood flow velocity in the femoral vein. Aust J Physiother. 2003;49(4):253-8. doi: 10.1016/s0004-9514(14)60141-0.

  PMID: 14632624 BACKGROUND

• Osada T, Katsumura T, Hamaoka T, Murase N, Naka M, Shimomitsu T. Quantitative effects of respiration on venous return during single knee extension-flexion. Int J Sports Med. 2002 Apr;23(3):183-90. doi: 10.1055/s-2002-23177.

  PMID: 11914981 BACKGROUND

• Tracz E, Zamojska E, Modrzejewski A, Zaborski D, Grzesiak W. Quality of life in patients with venous stasis ulcers and others with advanced venous insufficiency. Holist Nurs Pract. 2015 Mar-Apr;29(2):96-102. doi: 10.1097/HNP.0000000000000072.

  PMID: 25658932 BACKGROUND

MeSH Terms

Conditions

Blindness, Cortical

Condition Hierarchy (Ancestors)

Blindness; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Özlem Çinar Özdemir, Prof.Dr

  İzmir Democracy University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 21, 2025
• Study Start: July 5, 2023
• Primary Completion: May 10, 2024
• Study Completion: June 24, 2024
• Last Updated: January 21, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)