Clinical trial NCT03755180: Exercise Training in Venous Insufficiency
Official title: The Effectiveness of Exercise Training in Venous Insufficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Insufficiency
Keywords: Venous Insufficiency
Exercise
Compression Bandages
Duplex Doppler Ultrasonography
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Chronic Venous Disease Quality of Life Questionnaire (CIVIQ) 20
timeFrame: Change from Baseline Quality of Life at 6 weeks.
Secondary outcomes:
measure: Duplex Ultrasonography
timeFrame: Duplex Ultrasonography results is evaluated at baseline and six weeks rehabilitation program.
measure: Venous Clinical Severity Score (VCSS)
timeFrame: Assessment is performed at baseline and six weeks rehabilitation program.
measure: Visual Analogue Scale (VAS)
timeFrame: Assessment is performed at baseline and six weeks rehabilitation program.
measure: The 6 Minute Walk Test
timeFrame: Assessment is performed at baseline and six weeks rehabilitation program.
measure: 10-Meter Walk Test
timeFrame: Assessment is performed at baseline and six weeks rehabilitation program.
measure: Assessment of Muscle Strength with Handheld Dynamometer
timeFrame: Assessment is performed at baseline and six weeks rehabilitation program.
measure: Short Form 36 (SF-36)
timeFrame: Assessment is performed before treatment and after six weeks rehabilitation program.
measure: Measurement of Calf Girth
timeFrame: Assessment is performed at baseline and six weeks rehabilitation program.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Faculty of Medicine
state: Fatih
Study officials:
affiliation: Istanbul University Health Sciences Institute
name: Saliha Gürdal
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University Faculty of Health Science
name: İpek Yeldan
role: STUDY_DIRECTOR
References: