Venous InsufficiencyNCT03755180
Exercise Training in Venous Insufficiency
A study testing Exercise Training and Compression Therapy in people with Venous Insufficiency, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Venous Insufficiency
- What is being tested?
- Exercise Training and Compression Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Nov 2018to 17 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Faculty of Medicine
Istanbul, Fatih, 34093
About this study
Official title: 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.
Read the 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.
- Conditions
- Venous Insufficiency
- Being tested
- Exercise Training, Compression Therapy
- Keywords
- Venous Insufficiency, Exercise, Compression Bandages, Duplex Doppler Ultrasonography
- Medical subject headings
- Venous Insufficiency, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TrainingOther
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 TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Exercise Group Receives: Other: Exercise Training; Other: Compression Therapy |
| Group 2 | Active comparator | Compression Group Receives: Other: Compression Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from Baseline Quality of Life at 6 weeks.
Secondary outcomes (8)
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.
Measured: Duplex Ultrasonography results is evaluated at baseline and six weeks rehabilitation program.
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.
Measured: Assessment is performed at baseline and six weeks rehabilitation program.
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.
Measured: Assessment is performed at baseline and six weeks rehabilitation program.
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.
Measured: Assessment is performed at baseline and six weeks rehabilitation program.
10-Meter Walk Test
The 10mWT is used to assess walking speed in meters/second (m/s) over a short distance.
Measured: Assessment is performed at baseline and six weeks rehabilitation program.
Assessment of Muscle Strength with Handheld Dynamometer
The muscle strength of the gastrocnemius and tibialis anterior muscles will be evaluated using the handheld dynamometer.
Measured: Assessment is performed at baseline and six weeks rehabilitation program.
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.
Measured: Assessment is performed before treatment and after six weeks rehabilitation program.
Measurement of Calf Girth
Circumference measurements will be recorded at 10 cm intervals of both lower legs.
Measured: Assessment is performed at baseline and six weeks rehabilitation program.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start28 Nov 2018
- Primary completion17 Jun 2019
- Study completion17 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saliha Gürdal Karakelle, Istanbul University - Cerrahpasa
- Investigators
- Saliha Gürdal, Principal investigator, Istanbul University Health Sciences Instituteİpek Yeldan, Study director, Istanbul University Faculty of Health Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755180
- Sponsor's protocol ID
- 99984023-302.14.04-
- Status last verified
- Dec 2020
- First submitted
- 23 Nov 2018
- Last updated
- 30 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Exercise Training in Venous Insufficiency
- ClinicalTrials.gov ID
- NCT03755180
- Acronym / sponsor ID
- 99984023-302.14.04-
- Conditions
- Venous Insufficiency
- Keywords
- Venous Insufficiency, Exercise, Compression Bandages, Duplex Doppler Ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 17 Jun 2019 (actual)
- Study completion
- 17 Jun 2019 (actual)
- First posted
- 27 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Exercise Training, Other: Compression TherapyExercise Group |
| Group 2 | Active comparator | Other: Compression TherapyCompression Group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise TrainingIn 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 | Group 1 |
| Compression TherapyCompression 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. | Other | Group 1, Group 2 |
Primary outcome
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.
8 secondary outcomes
Duplex Ultrasonography
Time frame: 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.
Visual Analogue Scale (VAS)
Time frame: 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.
10-Meter Walk Test
Time frame: 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.
Short Form 36 (SF-36)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
- Individual participant dataSharing planned: No
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The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry
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Product Surveillance Registry
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saliha Gürdal principal investigator
Istanbul University Health Sciences Institute
İpek Yeldan study director
Istanbul University Faculty of Health Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Training and Compression Therapy in people with Venous Insufficiency, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic Venous Disease Quality of Life Questionnaire (CIVIQ) 20 (time frame: Change from Baseline Quality of Life at 6 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2020.