Efficacy of Active Versus Passive Methods in Chronic Venous Insufficiency

Study Overview
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Brief Summary
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The aim of our study was to compare the effectiveness of active and passive practices in patients with CVI.

Detailed Description
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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.

Official Title
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Comparison of the Efficacy of Active Versus Passive Methods in Patients With Chronic Venous Insufficiency

Conditions
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Chronic Venous Insufficiency

Intervention / Treatment
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* Other: Exercise Training
* Other: Massage
* Other: Neuromuscular Electrical Stimulation
* Other: Compression Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Compression Group<br>Routine compression therapy will be administered. | Other: Compression Therapy<br>* Compression therapy is a treatment applied to patients in the form of Four Layer Compression Bandage and Compression Stocking. Four Layer Compression Bandage is a treatment that requires four different types of bandages. The compression stocking is an elastic stock with various tension and length.<br>|
| Experimental: Active Group<br>Exercise training will be administered. | Other: Exercise Training<br>* Endurance training with a resistance-free bicycle ergometer Strength training with bodyweight Non-resistance ankle pumping exercises<br>Other: Compression Therapy<br>* Compression therapy is a treatment applied to patients in the form of Four Layer Compression Bandage and Compression Stocking. Four Layer Compression Bandage is a treatment that requires four different types of bandages. The compression stocking is an elastic stock with various tension and length.<br>|
| Experimental: Passive Group<br>Massageand neuromuscular electrical stimulation will be administered. | Other: Massage<br>* Classical massage including superficial and deep stroking and friction methods for the lower extremity.<br>Other: Neuromuscular Electrical Stimulation<br>* Symmetrical biphasic current at a frequency of 30-85 Hz<br>Other: Compression Therapy<br>* Compression therapy is a treatment applied to patients in the form of Four Layer Compression Bandage and Compression Stocking. Four Layer Compression Bandage is a treatment that requires four different types of bandages. The compression stocking is an elastic stock with various tension and length.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circumference measurements | Circumference measurements will be recorded at 4 cm intervals to evaluated to edema. | Change from Baseline circumferences at 8 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, compression, neuromuscular electrical stimulation, massage