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Completed

NCT Number: NCT05383469

Efficacy of Active Versus Passive Methods in Chronic Venous Insufficiency

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

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Key information

Conditions

Chronic Venous Insufficiency Behavior Motor Activity

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University-Cerrahpasa

Istanbul, Büyükçekmece, 34500, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise training

Other

Endurance training with a resistance-free bicycle ergometer Strength training with bodyweight Non-resistance ankle pumping exercises

Massage

Other

Classical massage including superficial and deep stroking and friction methods for the lower extremity.

Neuromuscular electrical stimulation

Other

Symmetrical biphasic current at a frequency of 30-85 Hz

Compression Therapy

Other

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 outcomes

  1. Circumference measurements

    Time frame: Change from Baseline circumferences at 8 weeks.

    Circumference measurements will be recorded at 4 cm intervals to evaluated to edema.

Secondary outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: 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.

  2. Venous Clinical Severity Score (VCSS)

    Time frame: 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.

  3. Handheld Dynamometer

    Time frame: 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.

  4. 6-Minute Walking Test

    Time frame: 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.

  5. 10-Meter Walking Test

    Time frame: 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.

  6. Chronic Venous Disease Quality of Life Questionnaire (CIVIQ) 20

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
May 20, 2022
Registry last updated
Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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