Back to resultsExercise Training in Venous Insufficiency
Primary Purpose
Venous Insufficiency
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise Training
Compression Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Venous Insufficiency focused on measuring Venous Insufficiency, Exercise, Compression Bandages, Duplex Doppler Ultrasonography
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
Sites / Locations
- Istanbul Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group 1
Group 2
Arm Description
Exercise Group
Compression Group
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
10-Meter Walk Test
The 10mWT is used to assess walking speed in meters/second (m/s) over a short distance.
Assessment of Muscle Strength with Handheld Dynamometer
The muscle strength of the gastrocnemius and tibialis anterior muscles will be evaluated using the handheld dynamometer.
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.
Measurement of Calf Girth
Circumference measurements will be recorded at 10 cm intervals of both lower legs.
Full Information
NCT ID
NCT03755180
First Posted
November 23, 2018
Last Updated
December 29, 2020
Sponsor
Istanbul University - Cerrahpasa (IUC)
1. Study Identification
Unique Protocol Identification Number
NCT03755180
Brief Title
Exercise Training in Venous Insufficiency
Official Title
The Effectiveness of Exercise Training in Venous Insufficiency
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
November 28, 2018 (Actual)
Primary Completion Date
June 17, 2019 (Actual)
Study Completion Date
June 17, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Insufficiency
Keywords
Venous Insufficiency, Exercise, Compression Bandages, Duplex Doppler Ultrasonography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Exercise Group
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Compression Group
Intervention Type
Other
Intervention Name(s)
Exercise Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Compression Therapy
Intervention Description
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 Outcome Measure Information:
Title
Chronic Venous Disease Quality of Life Questionnaire (CIVIQ) 20
Description
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.
Time Frame
Change from Baseline Quality of Life at 6 weeks.
Secondary Outcome Measure Information:
Title
Duplex Ultrasonography
Description
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.
Time Frame
Duplex Ultrasonography results is evaluated at baseline and six weeks rehabilitation program.
Title
Venous Clinical Severity Score (VCSS)
Description
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.
Time Frame
Assessment is performed at baseline and six weeks rehabilitation program.
Title
Visual Analogue Scale (VAS)
Description
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.
Time Frame
Assessment is performed at baseline and six weeks rehabilitation program.
Title
The 6 Minute Walk Test
Description
The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.
Time Frame
Assessment is performed at baseline and six weeks rehabilitation program.
Title
10-Meter Walk Test
Description
The 10mWT is used to assess walking speed in meters/second (m/s) over a short distance.
Time Frame
Assessment is performed at baseline and six weeks rehabilitation program.
Title
Assessment of Muscle Strength with Handheld Dynamometer
Description
The muscle strength of the gastrocnemius and tibialis anterior muscles will be evaluated using the handheld dynamometer.
Time Frame
Assessment is performed at baseline and six weeks rehabilitation program.
Title
Short Form 36 (SF-36)
Description
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.
Time Frame
Assessment is performed before treatment and after six weeks rehabilitation program.
Title
Measurement of Calf Girth
Description
Circumference measurements will be recorded at 10 cm intervals of both lower legs.
Time Frame
Assessment is performed at baseline and six weeks rehabilitation program.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saliha Gürdal
Organizational Affiliation
Istanbul University Health Sciences Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
İpek Yeldan
Organizational Affiliation
Istanbul University Faculty of Health Science
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul Faculty of Medicine
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34093
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Exercise Training in Venous Insufficiency
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