Venous InsufficiencyNCT04215133
Inspiratory Muscle Training Versus Calf Muscle on Venous Function
A study testing exercise therapy in people with Venous Insufficiency, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the effect of exercise training in addition to compression therapy on quality of life, venous return time, muscle strength, clinical severity, functional capacity in venous insufficiency compared to compression treatment alone. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Venous Insufficiency
- What is being tested?
- exercise therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jul 2019to 20 May 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of venous insufficiency between 18-75 years with duplex ultrasound imaging
- CEAP classification used in venous insufficiency is C2-C3-C4-C5
- Having written and verbal communication in Turkish
Who cannot join
- Acute deep vein thrombosis
- The presence of ulceration
- Being in class III and IV according to the New York Heart Association classification
- Presence of respiratory failure
- Undergoing chemotherapy due to the presence of any cancer
- Being in the process of treatment for neurological, orthopedic or rheumatologic diseases including lower extremity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University Cerrahpasa
Istanbul, 34959
GAMZE AYDIN, 05377600256, gmzetsn@gmail.com
About this study
Official title: Inspiratory Muscle Training Versus Calf Muscle on Venous Function in Patients With Chronic Venous Insufficiency
The aim of this study was to evaluate the effect of exercise training in addition to compression therapy on quality of life, venous return time, muscle strength, clinical severity, functional capacity in venous insufficiency compared to compression treatment alone. Fourty-two volunteer patients with venous insufficiency will include in the study were randomly divided into three groups as inspiratory exercise, calf muscle exercise and control. While the control group will receive only compression therapy, the inspiratory exercise group will apply inspiratory muscle training consisted of strengthening exercise in addition to compression therapy; kalf muscle exercise group will apply strengthening exercise for calf muscle in addition to compression therapy for 2 days/week with physiotherapist and 3 days/week by themselves, 8 weeks. All the patients will assess with Chronic Venous Disease Quality of life Questionnaire-20 (CIVIQ-20), Nottingham Health Profile, Photopletismograph, Venous Clinical Severity Score (VCSS), hand-held dynamometer, Visual Analogue Scale (VAS), circumference measurements, 6-minute walk test (6MWT), before and after the treatment.
- Conditions
- Venous Insufficiency
- Being tested
- exercise therapy
- Keywords
- venous insufficiency, exercise therapy, inspiratory muscle, kalf muscle, venous return
- Medical subject headings
- Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise therapyOther
inspiratory muscle training consists of strengthening exercise with threshold Inspiratory muscle training device and calf muscle training consist of isotonic and isometric strengthening exercise for calf muscle. All groups will receive compression therapy at the same time.
| Study group | Role | What they receive |
|---|---|---|
| İnspiratory muscle training group | Experimental | Not described Receives: Other: exercise therapy |
| Calf muscle training group | Experimental | Not described Receives: Other: exercise therapy |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Chronic Venous Insufficiency Questionnaire-20 (CIVIQ-20)
Quality of life
Measured: 12 months
Photoplethysmograph (PPG)
venous return time
Measured: 12 months
Secondary outcomes (5)
Hand held dynamometer
muscle strength
Measured: 12 months
Venous Clinical Severity Score (VCSS)
clinical severity
Measured: 12 months
6 minutes walk test
functional capacity
Measured: 12 months
digital goniometer
range of motion of ankle
Measured: 12 months
visual analog scale
pain
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start3 Jul 2019
- Primary completion14 May 2021
- Study completion20 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Aydin, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215133
- Sponsor's protocol ID
- IstanbulUCe
- Status last verified
- May 2021
- First submitted
- 25 Dec 2019
- Last updated
- 18 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aydin G, Yeldan I, Akgul A, Ipek G. Effects of inspiratory muscle training versus calf muscle training on quality of life, pain, venous function and activity in patients with chronic venous insufficiency. J Vasc Surg Venous Lymphat Disord. 2022 Sep;10(5):1137-1146. doi: 10.1016/j.jvsv.2022.04.012. Epub 2022 Jun 14.
PubMed 35710091
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Muscle Training Versus Calf Muscle on Venous Function in Patients With Chronic Venous Insufficiency
- ClinicalTrials.gov ID
- NCT04215133
- Acronym / sponsor ID
- IstanbulUCe
- Conditions
- Venous Insufficiency
- Keywords
- venous insufficiency, exercise therapy, inspiratory muscle, kalf muscle, venous return
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 14 May 2021 (actual)
- Study completion
- 20 May 2021 (estimated)
- First posted
- 2 Jan 2020 (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 was to evaluate the effect of exercise training in addition to compression therapy on quality of life, venous return time, muscle strength, clinical severity, functional capacity in venous insufficiency compared to compression treatment alone. Fourty-two volunteer patients with venous insufficiency will include in the study were randomly divided into three groups as inspiratory exercise, calf muscle exercise and control. While the control group will receive only compression therapy, the inspiratory exercise group will apply inspiratory muscle training consisted of strengthening exercise in addition to compression therapy; kalf muscle exercise group will apply strengthening exercise for calf muscle in addition to compression therapy for 2 days/week with physiotherapist and 3 days/week by themselves, 8 weeks. All the patients will assess with Chronic Venous Disease Quality of life Questionnaire-20 (CIVIQ-20), Nottingham Health Profile, Photopletismograph, Venous Clinical Severity Score (VCSS), hand-held dynamometer, Visual Analogue Scale (VAS), circumference measurements, 6-minute walk test (6MWT), before and after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| İnspiratory muscle training group | Experimental | Other: exercise therapy |
| Calf muscle training group | Experimental | Other: exercise therapy |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of venous insufficiency between 18-75 years with duplex ultrasound imaging
- CEAP classification used in venous insufficiency is C2-C3-C4-C5
- Having written and verbal communication in Turkish
Key exclusion criteria (6 listed)
- Acute deep vein thrombosis
- The presence of ulceration
- Being in class III and IV according to the New York Heart Association classification
- Presence of respiratory failure
- Undergoing chemotherapy due to the presence of any cancer
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 therapyinspiratory muscle training consists of strengthening exercise with threshold Inspiratory muscle training device and calf muscle training consist of isotonic and isometric strengthening exercise for calf muscle. All groups will receive compression therapy at the same time. | Other | Calf muscle training group, İnspiratory muscle training group |
Primary outcome
The Chronic Venous Insufficiency Questionnaire-20 (CIVIQ-20)
Time frame: 12 months
Quality of life
Photoplethysmograph (PPG)
Time frame: 12 months
venous return time
5 secondary outcomes
Hand held dynamometer
Time frame: 12 months
Venous Clinical Severity Score (VCSS)
Time frame: 12 months
6 minutes walk test
Time frame: 12 months
digital goniometer
Time frame: 12 months
visual analog scale
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Derived from this study: PubMed 35710091Aydin G, Yeldan I, Akgul A, Ipek G. Effects of inspiratory muscle training versus calf muscle training on quality of life, pain, venous function and activity in patients with chronic venous insufficiency. J Vasc Surg Venous Lymphat Disord. 2022 Sep;10(5):1137-1146. doi: 10.1016/j.jvsv.2022.04.012. Epub 2022 Jun 14.
- Individual participant dataSharing planned: No
Related trials for Venous Insufficiency
Not yet recruiting
Phenotyping Rehabilitation for Improving Frailty, Functional Capacity
Varicose Veins
Active, not recruiting
Comparison of the Effects of Kinesio Taping and Interval Exercise in Patients Diagnosed With Venous Insufficiency: A Randomised Controlled Trial
Chronic Venous Insufficiency C2 and Below
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease
Not yet recruitingObservational study
The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry
Chronic Venous Disease, Chronic Venous Insufficiency, CVI
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.
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 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 3 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: status not confirmed, as of the sponsor's last update on 18 May 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GAMZE AYDIN, MSc (+905377600256, gmzetsn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Chronic Venous Insufficiency Questionnaire-20 (CIVIQ-20) (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04215133, which also lists 1 linked publication.
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 18 May 2021.