Clinical trial NCT06196541: Respiratory and Physical Functions in Individuals With Chronic Venous Insufficiency
Official title: Edema, Pain, Respiratory Functions, Physical Functions and Quality of Life in Individuals With Chronic Venous Insufficiency
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Venous Insufficiency
Keywords: edema
pain
venous insufficiency
quality of life
respiratory function tests
maximal respiratory pressures
exercise capacity
Lead sponsor: Izmir Democracy University
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximal inspiratory pressure (MIP)
timeFrame: through study completion, an average of 1 year
measure: Maximal expiratory pressure (MEP)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Pain Intensity measured with the Numerical Rating Scale.
timeFrame: through study completion, an average of 1 year
measure: The distance of six-minute walk test
timeFrame: through study completion, an average of 1 year
measure: Lower extremity strength
timeFrame: through study completion, an average of 1 year
measure: Total quality of life score evaluated by Chronic Venous Disease Quality of Life Questionnaire
timeFrame: through study completion, an average of 1 year
measure: Forced vital capacity (FVC)
timeFrame: through study completion, an average of 1 year
measure: Forced expiratory volume in the first second (FEV1)
timeFrame: through study completion, an average of 1 year
measure: FEV1 / FVC
timeFrame: through study completion, an average of 1 year
measure: Flow rate 25-75% of forced expiratory volume (FEF 25-75%)
timeFrame: through study completion, an average of 1 year
measure: Peak flow rate (PEF)
timeFrame: through study completion, an average of 1 year
measure: edema
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: İ̇zmi̇r
country: Turkey
facility: Izmir Democracy University
Study officials:
affiliation: Izmir Democracy University
name: GÜLŞAH BARĞI, Assoc. Dr.
role: STUDY_DIRECTOR
affiliation: Izmir Democracy University
name: ÖZLEM ÖZLEM ÇİNAR ÖZDEMİR, Assoc. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Izmir Democracy University
name: CEMRE GÖRÜNMEZOĞLU, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Dokuz Eylul University
name: SADIK KIVANÇ METİN, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dokuz Eylul University
name: ECEM ÖZDEMİR
role: PRINCIPAL_INVESTIGATOR
affiliation: Dokuz Eylul University
name: EMEK NAZIM EKER
role: PRINCIPAL_INVESTIGATOR
affiliation: Dokuz Eylul University
name: ANIL GİRGİN
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.