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Clinical Trials/NCT03755180
NCT03755180
Completed
Not Applicable

The Effectiveness of Exercise Training in Venous Insufficiency

Istanbul University - Cerrahpasa (IUC)1 site in 1 country24 target enrollmentNovember 28, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Venous Insufficiency
Sponsor
Istanbul University - Cerrahpasa (IUC)
Enrollment
24
Locations
1
Primary Endpoint
Chronic Venous Disease Quality of Life Questionnaire (CIVIQ) 20
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
November 28, 2018
End Date
June 17, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Istanbul University - Cerrahpasa (IUC)
Responsible Party
Principal Investigator
Principal Investigator

Saliha Gürdal Karakelle

Research Assisstant

Istanbul University - Cerrahpasa (IUC)

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

Outcomes

Primary Outcomes

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

  • Venous Clinical Severity Score (VCSS)(Assessment is performed at baseline and six weeks rehabilitation program.)
  • The 6 Minute Walk Test(Assessment is performed at baseline and six weeks rehabilitation program.)
  • Duplex Ultrasonography(Duplex Ultrasonography results is evaluated at baseline and six weeks rehabilitation program.)
  • Measurement of Calf Girth(Assessment is performed at baseline and six weeks rehabilitation program.)
  • 10-Meter Walk Test(Assessment is performed at baseline and six weeks rehabilitation program.)
  • Assessment of Muscle Strength with Handheld Dynamometer(Assessment is performed at baseline and six weeks rehabilitation program.)
  • Visual Analogue Scale (VAS)(Assessment is performed at baseline and six weeks rehabilitation program.)
  • Short Form 36 (SF-36)(Assessment is performed before treatment and after six weeks rehabilitation program.)

Study Sites (1)

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