Venous Insufficiency Clinical Trial
Official title:
The Effectiveness of Exercise Training in Venous Insufficiency
Verified date | December 2020 |
Source | Istanbul University-Cerrahpasa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to evaluate the effects of exercise training in addition to compression therapy on clinical severity, vein diameter, reflux and quality of life in venous insufficiency patients.
Status | Completed |
Enrollment | 24 |
Est. completion date | June 17, 2019 |
Est. primary completion date | June 17, 2019 |
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 lower extremity - Presence of a psychiatric illness requiring the use of prescribed medicines |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul Faculty of Medicine | Istanbul | Fatih |
Lead Sponsor | Collaborator |
---|---|
Istanbul University-Cerrahpasa |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Change from Baseline Quality of Life at 6 weeks. | |
Secondary | Duplex Ultrasonography | Duplex Ultrasonography is a form of ultrasound that produces images that differentiate between the body's soft tissues and its fluid-filled structures. Duplex Ultrasonography provides information on vascular diameter and reflux in chronic venous insufficiency patients. | Duplex Ultrasonography results is evaluated at baseline and six weeks rehabilitation program. | |
Secondary | 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 is performed at baseline and six weeks rehabilitation program. | |
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 is performed at baseline and six weeks rehabilitation program. | |
Secondary | The 6 Minute Walk Test | The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. | Assessment is performed at baseline and six weeks rehabilitation program. | |
Secondary | 10-Meter Walk Test | The 10mWT is used to assess walking speed in meters/second (m/s) over a short distance. | Assessment is performed at baseline and six weeks rehabilitation program. | |
Secondary | Assessment of Muscle Strength with Handheld Dynamometer | The muscle strength of the gastrocnemius and tibialis anterior muscles will be evaluated using the handheld dynamometer. | Assessment is performed at baseline and six weeks rehabilitation program. | |
Secondary | Short Form 36 (SF-36) | SF-36 is used to assess physical and mental health-related quality of life. The total score is at least 0 and at most 100, and the high scores are positively correlated with the high quality of life. | Assessment is performed before treatment and after six weeks rehabilitation program. | |
Secondary | Measurement of Calf Girth | Circumference measurements will be recorded at 10 cm intervals of both lower legs. | Assessment is performed at baseline and six weeks rehabilitation program. |
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