Exercise Training in Venous Insufficiency

Venous Insufficiency Clinical Trial

Official title:

The Effectiveness of Exercise Training in Venous Insufficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03755180
• Other study ID #: 99984023-302.14.04-
• Status: Completed
• Phase: N/A
• Start date: November 28, 2018
• Est. completion date: June 17, 2019

Study information

• Verified date: December 2020
• Source: Istanbul University-Cerrahpasa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 17, 2019
• Est. primary completion date: June 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Venous Insufficiency

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Istanbul Faculty of Medicine	Istanbul	Fatih

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University-Cerrahpasa

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline Quality of Life at 6 weeks.
Secondary	Duplex Ultrasonography	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.
Secondary	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.	Assessment is performed at baseline and six weeks rehabilitation program.
Secondary	Visual Analogue Scale (VAS)	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.
Secondary	The 6 Minute Walk Test	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.
Secondary	10-Meter Walk Test	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.
Secondary	Assessment of Muscle Strength with Handheld Dynamometer	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.
Secondary	Short Form 36 (SF-36)	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.
Secondary	Measurement of Calf Girth	Circumference measurements will be recorded at 10 cm intervals of both lower legs.	Assessment is performed at baseline and six weeks rehabilitation program.