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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| The distance of six-minute walk test |
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Inclusion criteria for individuals with chronic venous insufficiency:
Exclusion criteria for individuals with chronic venous insufficiency:
Inclusion criteria for asymptomatic healthy individuals:
Exclusion criteria for asymptomatic healthy individuals:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Izmir Democracy University | Izmir | 35140 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11235498 | Background | 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. | |
| 22682424 | 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. |
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| ID | Term |
|---|---|
| D004487 | Edema |
| D010146 | Pain |
| D014689 | Venous Insufficiency |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D014652 | Vascular Diseases |
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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 |
| 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 |
| 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 |
| Forced vital capacity (FVC) | Pulmonary function (Forced vital capacity (FVC) will be evaluated with a spirometer. | through study completion, an average of 1 year |
| 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 |
| FEV1 / FVC | Pulmonary function (FEV1 / FVC) will be evaluated with a spirometer. | through study completion, an average of 1 year |
| 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 |
| Peak flow rate (PEF) | Pulmonary function (Peak flow rate (PEF) will be evaluated with a spirometer. | through study completion, an average of 1 year |
| 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 |
| 35710091 | 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. |
| D002318 | Cardiovascular Diseases |