Chronic Venous InsufficiencyNCT05383469
Efficacy of Active Versus Passive Methods in Chronic Venous Insufficiency
A study testing Exercise Training, Massage and Neuromuscular Electrical Stimulation in people with Chronic Venous Insufficiency, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study was to compare the effectiveness of active and passive practices in patients with CVI. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Venous Insufficiency
- What is being tested?
- Exercise Training, Massage and Neuromuscular Electrical Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Sep 2022to 2 Sep 2023
- 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 the 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 University-Cerrahpasa
Istanbul, Büyükçekmece, 34500
About this study
Official title: Comparison of the Efficacy of Active Versus Passive Methods in Patients With Chronic Venous Insufficiency
The aim of our study was to compare the effectiveness of active and passive practices in patients with CVI.
Read the detailed description
Volunteers who have been diagnosed with venous insufficiency according to the criteria of inclusion, who applied to Cardiovascular Surgery Department will be included this study.
Participants will be randomly allocated 3 groups using the 'Research Randomizer' website. In all groups, a common evaluation protocol will be applied to the patients.
Compression therapy will be applied to the first group. Active treatment in addition to compression therapy will be applied to the second group. Passive treatment in addition to compression therapy will be applied to the third group.
- Conditions
- Chronic Venous Insufficiency
- Being tested
- Exercise Training, Massage, Neuromuscular Electrical Stimulation, Compression Therapy
- Keywords
- exercise, compression, neuromuscular electrical stimulation, massage
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TrainingOther
Endurance training with a resistance-free bicycle ergometer Strength training with bodyweight Non-resistance ankle pumping exercises
MassageOther
Classical massage including superficial and deep stroking and friction methods for the lower extremity.
Neuromuscular Electrical StimulationOther
Symmetrical biphasic current at a frequency of 30-85 Hz
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 |
|---|---|---|
| Compression Group | Active comparator | Routine compression therapy will be administered. Receives: Other: Compression Therapy |
| Active Group | Experimental | Exercise training will be administered. Receives: Other: Exercise Training; Other: Compression Therapy |
| Passive Group | Experimental | Massageand neuromuscular electrical stimulation will be administered. Receives: Other: Massage; Other: Neuromuscular Electrical Stimulation; Other: Compression Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circumference measurements
Circumference measurements will be recorded at 4 cm intervals to evaluated to edema.
Measured: Change from Baseline circumferences at 8 weeks.
Secondary outcomes (6)
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 will be performed at baseline and at 8 weeks.
Venous Clinical Severity Score (VCSS)
Clinical severity will be measured by 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 will be performed tat baseline and at 8 weeks.
Handheld Dynamometer
The muscle strength of the gastrocnemius and tibialis anterior muscles will be evaluated using the handheld dynamometer.
Measured: Assessment will be performed at baseline and at 8 weeks.
6-Minute Walking Test
Functional capacity will be evaluated with the 6-minute walking test. The 6-minute walking test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes.
Measured: Assessment will be performed at baseline and at 8 weeks.
10-Meter Walking Test
Walking speed will be evaluated with the 10-meter walking test. 10-meter walking test is used to assess walking speed in meters/second (m/s) over a short distance.
Measured: Assessment will be performed at baseline and at 8 weeks.
Chronic Venous Disease Quality of Life Questionnaire (CIVIQ) 20
Quality of Life will be evaluated with the 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: Assessment will be performed at baseline and at 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start13 Sep 2022
- Primary completion25 Dec 2022
- Study completion2 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Venous InsufficiencyStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- 66 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383469
- Sponsor's protocol ID
- 99984023-302.14.68-
- Status last verified
- Nov 2023
- First submitted
- 9 Feb 2022
- Last updated
- 14 Nov 2023
- 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 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Active Versus Passive Methods in Patients With Chronic Venous Insufficiency
- ClinicalTrials.gov ID
- NCT05383469
- Acronym / sponsor ID
- 99984023-302.14.68-
- Conditions
- Chronic Venous Insufficiency
- Keywords
- exercise, compression, neuromuscular electrical stimulation, massage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 25 Dec 2022 (actual)
- Study completion
- 2 Sep 2023 (actual)
- First posted
- 20 May 2022 (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 our study was to compare the effectiveness of active and passive practices in patients with CVI.
Detailed description
Volunteers who have been diagnosed with venous insufficiency according to the criteria of inclusion, who applied to Cardiovascular Surgery Department will be included this study.
Participants will be randomly allocated 3 groups using the 'Research Randomizer' website. In all groups, a common evaluation protocol will be applied to the patients.
Compression therapy will be applied to the first group. Active treatment in addition to compression therapy will be applied to the second group. Passive treatment in addition to compression therapy will be applied to the third group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Compression Group | Active comparator | Other: Compression TherapyRoutine compression therapy will be administered. |
| Active Group | Experimental | Other: Exercise Training, Other: Compression TherapyExercise training will be administered. |
| Passive Group | Experimental | Other: Massage, Other: Neuromuscular Electrical Stimulation, Other: Compression TherapyMassageand neuromuscular electrical stimulation will be administered. |
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 the 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 TrainingEndurance training with a resistance-free bicycle ergometer Strength training with bodyweight Non-resistance ankle pumping exercises | Other | Active Group |
| MassageClassical massage including superficial and deep stroking and friction methods for the lower extremity. | Other | Passive Group |
| Neuromuscular Electrical StimulationSymmetrical biphasic current at a frequency of 30-85 Hz | Other | Passive Group |
| 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 | Active Group, Compression Group, Passive Group |
Primary outcome
Circumference measurements
Time frame: Change from Baseline circumferences at 8 weeks.
Circumference measurements will be recorded at 4 cm intervals to evaluated to edema.
6 secondary outcomes
Visual Analogue Scale (VAS)
Time frame: Assessment will be performed at baseline and at 8 weeks.
Venous Clinical Severity Score (VCSS)
Time frame: Assessment will be performed tat baseline and at 8 weeks.
Handheld Dynamometer
Time frame: Assessment will be performed at baseline and at 8 weeks.
6-Minute Walking Test
Time frame: Assessment will be performed at baseline and at 8 weeks.
10-Meter Walking Test
Time frame: Assessment will be performed at baseline and at 8 weeks.
Chronic Venous Disease Quality of Life Questionnaire (CIVIQ) 20
Time frame: Assessment will be performed at baseline and at 8 weeks.
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 14 Nov 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, Massage and Neuromuscular Electrical Stimulation in people with Chronic 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 14 Nov 2023. 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?
Circumference measurements (time frame: Change from Baseline circumferences at 8 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 14 Nov 2023.