Back to resultsEfficacy of Active Versus Passive Methods in Chronic Venous Insufficiency
Primary Purpose
Chronic Venous Insufficiency
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise Training
Massage
Neuromuscular Electrical Stimulation
Compression Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Venous Insufficiency focused on measuring exercise, compression, neuromuscular electrical stimulation, massage
Eligibility Criteria
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
Sites / Locations
- Istanbul University-Cerrahpasa
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Compression Group
Active Group
Passive Group
Arm Description
Routine compression therapy will be administered.
Exercise training will be administered.
Massageand neuromuscular electrical stimulation will be administered.
Outcomes
Primary Outcome Measures
Circumference measurements
Circumference measurements will be recorded at 4 cm intervals to evaluated to edema.
Secondary Outcome Measures
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.
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.
Handheld Dynamometer
The muscle strength of the gastrocnemius and tibialis anterior muscles will be evaluated using the handheld dynamometer.
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.
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.
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.
Full Information
NCT ID
NCT05383469
First Posted
February 9, 2022
Last Updated
September 22, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
1. Study Identification
Unique Protocol Identification Number
NCT05383469
Brief Title
Efficacy of Active Versus Passive Methods in Chronic Venous Insufficiency
Official Title
Comparison of the Efficacy of Active Versus Passive Methods in Patients With Chronic Venous Insufficiency
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 13, 2022 (Actual)
Primary Completion Date
December 25, 2022 (Actual)
Study Completion Date
June 2, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Venous Insufficiency
Keywords
exercise, compression, neuromuscular electrical stimulation, massage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Compression Group
Arm Type
Active Comparator
Arm Description
Routine compression therapy will be administered.
Arm Title
Active Group
Arm Type
Experimental
Arm Description
Exercise training will be administered.
Arm Title
Passive Group
Arm Type
Experimental
Arm Description
Massageand neuromuscular electrical stimulation will be administered.
Intervention Type
Other
Intervention Name(s)
Exercise Training
Intervention Description
Endurance training with a resistance-free bicycle ergometer Strength training with bodyweight Non-resistance ankle pumping exercises
Intervention Type
Other
Intervention Name(s)
Massage
Intervention Description
Classical massage including superficial and deep stroking and friction methods for the lower extremity.
Intervention Type
Other
Intervention Name(s)
Neuromuscular Electrical Stimulation
Intervention Description
Symmetrical biphasic current at a frequency of 30-85 Hz
Intervention Type
Other
Intervention Name(s)
Compression Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Circumference measurements
Description
Circumference measurements will be recorded at 4 cm intervals to evaluated to edema.
Time Frame
Change from Baseline circumferences at 8 weeks.
Secondary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
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.
Time Frame
Assessment will be performed at baseline and at 8 weeks.
Title
Venous Clinical Severity Score (VCSS)
Description
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.
Time Frame
Assessment will be performed tat baseline and at 8 weeks.
Title
Handheld Dynamometer
Description
The muscle strength of the gastrocnemius and tibialis anterior muscles will be evaluated using the handheld dynamometer.
Time Frame
Assessment will be performed at baseline and at 8 weeks.
Title
6-Minute Walking Test
Description
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.
Time Frame
Assessment will be performed at baseline and at 8 weeks.
Title
10-Meter Walking Test
Description
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.
Time Frame
Assessment will be performed at baseline and at 8 weeks.
Title
Chronic Venous Disease Quality of Life Questionnaire (CIVIQ) 20
Description
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.
Time Frame
Assessment will be performed at baseline and at 8 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
State/Province
Büyükçekmece
ZIP/Postal Code
34500
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Active Versus Passive Methods in Chronic Venous Insufficiency
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