Chronic Venous Insufficiency Clinical Trial
Official title:
Edema, Pain, Respiratory Functions, Physical Functions and Quality of Life in Individuals With Chronic Venous Insufficiency
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Izmir Democracy University | I?zmi?r |
Lead Sponsor | Collaborator |
---|---|
Izmir Democracy University |
Turkey,
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
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 |
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