Exercise Training in Venous Insufficiency

December 29, 2020 updated by: Saliha Gürdal Karakelle, Istanbul University - Cerrahpasa (IUC)

The Effectiveness of 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Fatih
      • Istanbul, Fatih, Turkey, 34093
        • Istanbul Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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 lower extremity
  • Presence of a psychiatric illness requiring the use of prescribed medicines

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group 1
Exercise Group
Other: Exercise Training
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.
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.
ACTIVE_COMPARATOR: Group 2
Compression Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from Baseline Quality of Life at 6 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Duplex Ultrasonography results is evaluated at baseline and six weeks rehabilitation program.
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.
Assessment is performed at baseline and six weeks rehabilitation program.
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.
Assessment is performed at baseline and six weeks rehabilitation program.
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.
Assessment is performed at baseline and six weeks rehabilitation program.
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.
Assessment is performed at baseline and six weeks rehabilitation program.
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.
Assessment is performed at baseline and six weeks rehabilitation program.
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.
Assessment is performed before treatment and after six weeks rehabilitation program.
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.
Assessment is performed at baseline and six weeks rehabilitation program.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Principal Investigator: Saliha Gürdal, Istanbul University Health Sciences Institute
  • Study Director: İpek Yeldan, Istanbul University Faculty of Health Science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 28, 2018

Primary Completion (ACTUAL)

June 17, 2019

Study Completion (ACTUAL)

June 17, 2019

Study Registration Dates

First Submitted

November 23, 2018

First Submitted That Met QC Criteria

November 26, 2018

First Posted (ACTUAL)

November 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

December 30, 2020

Last Update Submitted That Met QC Criteria

December 29, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 99984023-302.14.04-

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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