Efficacy of Active Versus Passive Methods in Chronic Venous Insufficiency
- Conditions
- Chronic Venous Insufficiency
- Interventions
- Other: Compression TherapyOther: Exercise TrainingOther: MassageOther: Neuromuscular Electrical Stimulation
- Registration Number
- NCT05383469
- Lead Sponsor
- Istanbul University - Cerrahpasa (IUC)
- Brief Summary
The aim of our study was to compare the effectiveness of active and passive practices in patients with CVI.
- Detailed Description
Volunteers who have been diagnosed with venous insufficiency according to the criteria of inclusion, who applied to Cardiovascular Surgery Department will be included this study.
Participants will be randomly allocated 3 groups using the 'Research Randomizer' website. In all groups, a common evaluation protocol will be applied to the patients.
Compression therapy will be applied to the first group. Active treatment in addition to compression therapy will be applied to the second group. Passive treatment in addition to compression therapy will be applied to the third group.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Compression Group Compression Therapy Routine compression therapy will be administered. Active Group Exercise Training Exercise training will be administered. Passive Group Massage Massageand neuromuscular electrical stimulation will be administered. Passive Group Neuromuscular Electrical Stimulation Massageand neuromuscular electrical stimulation will be administered. Passive Group Compression Therapy Massageand neuromuscular electrical stimulation will be administered. Active Group Compression Therapy Exercise training will be administered.
- Primary Outcome Measures
Name Time Method Circumference measurements Change from Baseline circumferences at 8 weeks. Circumference measurements will be recorded at 4 cm intervals to evaluated to edema.
- Secondary Outcome Measures
Name Time Method 6-Minute Walking Test Assessment will be performed at baseline and at 8 weeks. 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.
Visual Analogue Scale (VAS) Assessment will be performed at baseline and at 8 weeks. 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.
Handheld Dynamometer Assessment will be performed at baseline and at 8 weeks. The muscle strength of the gastrocnemius and tibialis anterior muscles will be evaluated using the handheld dynamometer.
Chronic Venous Disease Quality of Life Questionnaire (CIVIQ) 20 Assessment will be performed at baseline and at 8 weeks. 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.
Venous Clinical Severity Score (VCSS) Assessment will be performed tat baseline and at 8 weeks. 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.
10-Meter Walking Test Assessment will be performed at baseline and at 8 weeks. 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.
Trial Locations
- Locations (1)
Istanbul University-Cerrahpasa
🇹🇷Istanbul, Büyükçekmece, Turkey