Chronic Venous Insufficiency Clinical Trial
Official title:
Comparison of the Efficacy of Active Versus Passive Methods in Patients With Chronic Venous Insufficiency
Verified date | November 2023 |
Source | Istanbul University - Cerrahpasa (IUC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of our study was to compare the effectiveness of active and passive practices in patients with CVI.
Status | Completed |
Enrollment | 66 |
Est. completion date | September 2, 2023 |
Est. primary completion date | December 25, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Diagnosis of venous insufficiency with duplex ultrasonography - Classification of CEAP (Clinical-Etiological-Anatomical-Pathological) used in venous insufficiency is C3-C4-C5-C6 - Ankle-brachial index (ABI) is less than 0.7 - Possibility to communicate in written and verbal in Turkish - Have a level of cognitive ability to understand the instructions given Exclusion Criteria: - Presence of deep vein thrombosis - Ulceration or open burn wound in lower extremity greater than 4 cm - Presence of infected ulceration - Cardiorespiratory insufficiency - Orthopedic, rheumatologic or neurological comorbidities restrain the exercise in the lower extremity - Presence of a psychiatric illness requiring the use of prescribed medicines |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul University-Cerrahpasa | Istanbul | Büyükçekmece |
Lead Sponsor | Collaborator |
---|---|
Istanbul University - Cerrahpasa (IUC) |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Circumference measurements | Circumference measurements will be recorded at 4 cm intervals to evaluated to edema. | Change from Baseline circumferences at 8 weeks. | |
Secondary | Visual Analogue Scale (VAS) | The levels of pain felt rest/activity/night will be measured using visual analogue scale (VAS). Patients will be asked to evaluate their pain status with a 10-point scale and high scores are positively correlated with pain. | Assessment will be performed at baseline and at 8 weeks. | |
Secondary | Venous Clinical Severity Score (VCSS) | Clinical severity will be measured by Venous Clinical Severity Score (VCSS).The VCSS was subsequently developed as an evaluative instrument that would be responsive to changes in disease severity over time and in response to treatment.The total score is at least 0 and at most 30, and the low scores are positively correlated with the severe clinical condition. | Assessment will be performed tat baseline and at 8 weeks. | |
Secondary | Handheld Dynamometer | The muscle strength of the gastrocnemius and tibialis anterior muscles will be evaluated using the handheld dynamometer. | Assessment will be performed at baseline and at 8 weeks. | |
Secondary | 6-Minute Walking Test | Functional capacity will be evaluated with the 6-minute walking test. The 6-minute walking test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. | Assessment will be performed at baseline and at 8 weeks. | |
Secondary | 10-Meter Walking Test | Walking speed will be evaluated with the 10-meter walking test. 10-meter walking test is used to assess walking speed in meters/second (m/s) over a short distance. | Assessment will be performed at baseline and at 8 weeks. | |
Secondary | Chronic Venous Disease Quality of Life Questionnaire (CIVIQ) 20 | Quality of Life will be evaluated with the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ) 20. CIVIQ 20 is a disease-related quality of life assessment form especially for chronic venous insufficiency patients. The total score is at least 0 and at most 100, and the higher scores indicate better quality of life. | Assessment will be performed at baseline and at 8 weeks. |
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