Efficacy of Active Versus Passive Methods in Chronic Venous Insufficiency

Chronic Venous Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05383469
• Other study ID #: 99984023-302.14.68-
• Status: Completed
• Phase: N/A
• Start date: September 13, 2022
• Est. completion date: September 2, 2023

Study information

• Verified date: November 2023
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• 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

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Venous Insufficiency

Intervention

Other:
• Exercise Training
Endurance training with a resistance-free bicycle ergometer Strength training with bodyweight Non-resistance ankle pumping exercises
• Massage
Classical massage including superficial and deep stroking and friction methods for the lower extremity.
• Neuromuscular Electrical Stimulation
Symmetrical biphasic current at a frequency of 30-85 Hz
• Compression Therapy
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.

Locations

Country	Name	City	State
Turkey	Istanbul University-Cerrahpasa	Istanbul	Büyükçekmece

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

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.