Efficacy of Active Versus Passive Methods in Chronic Venous Insufficiency

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Venous Insufficiency
• Intervention / Treatment: Other: Compression Therapy; Other: Exercise Training; Other: Massage; Other: Neuromuscular Electrical Stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Saliha Gürdal Karakelle, MSc; Phone Number: 00905555925304; Email: salihagurdal@hotmail.com
• Study Contact Backup: Name: İpek Yeldan Karagöz, PhD; Phone Number: 00905426513818; Email: ipekyeldan@gmail.com

Study Locations

• Turkey
  • Büyükçekmece
    • Istanbul, Büyükçekmece, Turkey, 34500
      • Istanbul University-Cerrahpasa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Compression Group; Routine compression therapy will be administered.	Other: 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.
Experimental: Active Group; Exercise training will be administered.	Other: 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.; Other: Exercise Training; Endurance training with a resistance-free bicycle ergometer Strength training with bodyweight Non-resistance ankle pumping exercises
Experimental: Passive Group; Massageand neuromuscular electrical stimulation will be administered.	Other: 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.; Other: Massage; Classical massage including superficial and deep stroking and friction methods for the lower extremity.; Other: Neuromuscular Electrical Stimulation; Symmetrical biphasic current at a frequency of 30-85 Hz

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa (IUC)

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2022
• Primary Completion (Actual): December 25, 2022
• Study Completion (Actual): September 2, 2023

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (Actual): May 20, 2022

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: exercise; neuromuscular electrical stimulation; massage; compression
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency
• Other Study ID Numbers: 99984023-302.14.68-

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No