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Completed

NCT Number: NCT03755180

Exercise Training in Venous Insufficiency

The aim of this study is to evaluate the effects of exercise training in addition to compression therapy on clinical severity, vein diameter, reflux and quality of life in venous insufficiency patients.

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Key information

Conditions

Venous Insufficiency Behavior Cardiovascular Diseases Motor Activity Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Faculty of Medicine

Istanbul, Fatih, 34093, Turkey (Türkiye)

About this study

Volunteers who have been diagnosed with venous insufficiency according to the criteria of inclusion, who applied to Istanbul University Istanbul Medical Faculty Cardiovascular Surgery Department will be included this study.

Participants will be randomly allocated 2 groups using the 'Research Randomizer' website. In both groups, a common evaluation protocol will be applied to the patients.

Exercise training in addition to compression bandages will be applied to first group, compression bandages will be applied to second 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 lower extremity
  • Presence of a psychiatric illness requiring the use of prescribed medicines

Treatment and study plan

Exercise training

Other

In exercise training, aerobic exercise and strengthening exercises, especially for gastrocnemius and tibialis anterior muscles, will be applied to the patients. In addition the exercise training, Compression Therapy is applied to patients.

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

    Time frame: Change from Baseline Quality of Life at 6 weeks.

    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.

Secondary outcomes

  1. Duplex Ultrasonography

    Time frame: Duplex Ultrasonography results is evaluated at baseline and six weeks rehabilitation program.

    Duplex Ultrasonography is a form of ultrasound that produces images that differentiate between the body's soft tissues and its fluid-filled structures. Duplex Ultrasonography provides information on vascular diameter and reflux in chronic venous insufficiency patients.

  2. Venous Clinical Severity Score (VCSS)

    Time frame: Assessment is performed at baseline and six weeks rehabilitation program.

    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. Visual Analogue Scale (VAS)

    Time frame: Assessment is performed at baseline and six weeks rehabilitation program.

    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.

  4. The 6 Minute Walk Test

    Time frame: Assessment is performed at baseline and six weeks rehabilitation program.

    The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.

  5. 10-Meter Walk Test

    Time frame: Assessment is performed at baseline and six weeks rehabilitation program.

    The 10mWT is used to assess walking speed in meters/second (m/s) over a short distance.

  6. Assessment of Muscle Strength with Handheld Dynamometer

    Time frame: Assessment is performed at baseline and six weeks rehabilitation program.

    The muscle strength of the gastrocnemius and tibialis anterior muscles will be evaluated using the handheld dynamometer.

  7. Short Form 36 (SF-36)

    Time frame: Assessment is performed before treatment and after six weeks rehabilitation program.

    SF-36 is used to assess physical and mental health-related quality of life. The total score is at least 0 and at most 100, and the high scores are positively correlated with the high quality of life.

  8. Measurement of Calf Girth

    Time frame: Assessment is performed at baseline and six weeks rehabilitation program.

    Circumference measurements will be recorded at 10 cm intervals of both lower legs.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

The Effectiveness of Exercise Training in Venous Insufficiency

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 27, 2018
Registry last updated
Dec 30, 2020

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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