Respiratory and Physical Functions in Individuals With Chronic Venous Insufficiency

Chronic Venous Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06196541
• Other study ID #: Chronic venous insufficiency
• Status: Recruiting
• Start date: December 27, 2023
• Est. completion date: December 2026

Study information

• Verified date: February 2024
• Source: Izmir Democracy University
• Contact: GÜLSAH BARGI, Assoc. Dr.
• Phone: +90 232 299 0739
• Email: gulsahbargi35[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Venous Insufficiency

Locations

Country	Name	City	State
Turkey	Izmir Democracy University	I?zmi?r

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Democracy University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Pain Intensity measured with the Numerical Rating Scale.	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).	through study completion, an average of 1 year
Secondary	The distance of six-minute walk test	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.	through study completion, an average of 1 year
Secondary	Lower extremity strength	To determine lower extremity strength and functional mobility, the 30-second Sit-Up Test will be used in the chair.	through study completion, an average of 1 year
Secondary	Total quality of life score evaluated by Chronic Venous Disease Quality of Life Questionnaire	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.	through study completion, an average of 1 year
Secondary	Forced vital capacity (FVC)	Pulmonary function (Forced vital capacity (FVC) will be evaluated with a spirometer.	through study completion, an average of 1 year
Secondary	Forced expiratory volume in the first second (FEV1)	Pulmonary function (Forced expiratory volume in the first second (FEV1) will be evaluated with a spirometer.	through study completion, an average of 1 year
Secondary	FEV1 / FVC	Pulmonary function (FEV1 / FVC) will be evaluated with a spirometer.	through study completion, an average of 1 year
Secondary	Flow rate 25-75% of forced expiratory volume (FEF 25-75%)	Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be evaluated with a spirometer.	through study completion, an average of 1 year
Secondary	Peak flow rate (PEF)	Pulmonary function (Peak flow rate (PEF) will be evaluated with a spirometer.	through study completion, an average of 1 year
Secondary	edema	Edema in the lower extremity will be evaluated by measuring the circumference using a tape measure.	through study completion, an average of 1 year