Chronic Venous InsufficiencyNCT05982405
Long-term Effects of Inspiratory Muscle Training in Chronic Venous Insufficiency
A study testing Training group: Inspiratory muscle training in people with Chronic Venous Insufficiency, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
Trial summary
The long-term effectiveness of inspiratory muscle training, which is known in the literature to help venous return by increasing the pump effect of the diaphragm muscle, remains unclear in individuals with chronic venous insufficiency. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Venous Insufficiency
- What is being tested?
- Training group: Inspiratory muscle training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2023to 30 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Volunteering to participate in the study
- Diagnosed with chronic venous insufficiency using duplex ultrasound and being under standard medical treatment follow-up
- Being in one of the C1, C2, C3, C4 or C5 stages according to the Clinical, Etiology, Anatomy and Pathophysiology (CEAP) classification
Who cannot join
- Acute deep vein thrombosis, active ulcers, psychiatric disorder requiring prior vessel ablation and/or prescription drug therapy,
- Any history of chronic disease or deep vein thrombosis that may interfere with exercise capacity measurement,
- Having SARS-CoV-2 (COVID-19) or any acute infection,
- Being pregnant,
- History of arterial disease,
- Having advanced cardiorespiratory diseases, acute ulcer (< 3 months) and diabetic ulcers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Effects of Inspiratory Muscle Training in Individuals With Chronic Venous Insufficiency
The long-term effectiveness of inspiratory muscle training, which is known in the literature to help venous return by increasing the pump effect of the diaphragm muscle, remains unclear in individuals with chronic venous insufficiency. For this reason, in this study, it was aimed to investigate the long-term results of inspiratory muscle training in individuals with chronic venous insufficiency.
Read the detailed description
Initial treatment of chronic venous insufficiency (CVI) includes conservative methods such as reducing symptoms and helping to prevent secondary problems and disease progression. If conservative methods fail, further treatments based on anatomical and physiological pathophysiological features should be applied. Treatment of CVI ranges from simple compression stockings to very complicated venous reconstructions. Physiotherapy applications also have an important place in the treatment of CVI and contain patient education, complex decongestive physiotherapy, intermittent pneumatic compression, compression garment, venous exercise programs, biomechanical stimulation therapy, proprioceptive neuromuscular facilitation, relaxation techniques and hydrotherapy methods.
Researches investigating the effectiveness of new physiotherapy applications in CVI are very limited. In one of these publications, the effects of inspiratory muscle training (IMT) and calf muscle exercise training (CMET) applied in addition to compression therapy (CT) on quality of life (QoL), venous filling time, disease severity, pain, edema, range of motion, muscle strength and functionality were investigated newly. IMT and CT were applied in group 1, CMET and CT were applied in group 2, and only CT was applied in group 3. As a result, groups of 1 and 2 showed more improvement in these outcomes compared to other groups. Acute effects of inspiratory muscle training in CVI was only shown in this study. The long-term effectiveness of inspiratory muscle training is still unclear in individuals with CVI. Therefore, this study aimed to investigate the long-term results of inspiratory muscle training in individuals with CVI.
- Conditions
- Chronic Venous Insufficiency
- Being tested
- Training group: Inspiratory muscle training, Control group: Thoracic expansion exercise
- Keywords
- Venous Insufficiency, pain, edema, respiratory function tests, maximal respiratory pressures, exercise capacity, quality of life
- Medical subject headings
- Venous Insufficiency, Pain, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training group: Inspiratory muscle trainingOther
Also called Experimental: Training group
The individuals in the training group will be performed inspiratory muscle training at 30-50% of the maximal inspiratory pressure. Inspiratory muscle training will be done using an inspiratory muscle training device (PowerBreathe®) that works with the threshold loading principle. Inspiratory muscle training will be done for 15 minutes per a session, 2 times per a day or, if tolerated, 30 minutes per a day and 1 time per a day, 5-7 days/week (one session under the supervision and the others at home), for a total of 6 weeks. Applications made at home will be followed with a diary.
Control group: Thoracic expansion exerciseOther
Also called Sham Comparator: Control group
Individuals in the control group will be performed thoracic expansion exercises. Thoracic expansion exercises will be applied to individuals in an upright sitting position. In this position, individuals will place their hands on their lower ribs and then perform the cycle of "deep breathing + holding the deep breath for 3 seconds + slowly emptying all the breath" 3 times in a row. After this cycle, individuals will be asked to rest by taking 3-4 calm breaths. Immediately after, the individual will be asked to repeat the same cycle and repeat the cycle with calm breaths and rest until it reaches 10 repetitions. The individual will do this session 4 times a day. Individuals will do the first session of breathing exercises under supervision. In this way, incorrect exercise will be prevented. Other breathing exercise sessions will be done by individuals as a home program every day and 4 sessions a day during 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Training group | Experimental | The individuals in the training group will be performed inspiratory muscle training using an inspiratory muscle training device (PowerBreathe®) at 30-50% of the maximal inspiratory pressure. Receives: Other: Training group: Inspiratory muscle training |
| Control group | Sham comparator | Individuals in the control group will be performed thoracic expansion exercises. Receives: Other: Control group: Thoracic expansion exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal inspiratory pressure (MIP)
The MIP which shows respiratory muscle strength will be evaluated using a portable mouth pressure measuring device based on American Thoracic Society and European Respiratory Society criteria.
Measured: After 6-week training and 3 months after 6-week training ends.
Secondary outcomes (10)
Maximal expiratory pressure (MEP)
The MEP which shows respiratory muscle strength will be evaluated using a portable mouth pressure measuring device based on American Thoracic Society and European Respiratory Society criteria.
Measured: After 6-week training and 3 months after 6-week training ends.
Forced vital capacity (FVC)
Pulmonary function (Forced vital capacity (FVC)) will be evaluated with a spirometer.
Measured: After 6-week training and 3 months after 6-week training ends.
Forced expiratory volume in the first second (FEV1)
Pulmonary function (Forced expiratory volume in the first second (FEV1)) will be evaluated with a spirometer.
Measured: After 6-week training and 3 months after 6-week training ends.
FEV1 / FVC
Pulmonary function (FEV1 / FVC) will be evaluated with a spirometer.
Measured: After 6-week training and 3 months after 6-week training ends.
Flow rate 25-75% of forced expiratory volume (FEF 25-75%)
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%)) will be evaluated with a spirometer.
Measured: After 6-week training and 3 months after 6-week training ends.
Peak flow rate (PEF)
Pulmonary function (Peak flow rate (PEF)) will be evaluated with a spirometer.
Measured: After 6-week training and 3 months after 6-week training ends.
Pain Intensity measured with the Numerical Rating Scale.
Pain intensity will be measured with the Numerical Rating Scale. This scale expresses the severity of pain with integers from 0 (no pain) to 10 (the worst possible pain).
Measured: After 6-week training and 3 months after 6-week training ends.
Aerobic capacity
The six-minute walk test (6-MWT) will be performed according to the criteria of the American Thoracic Society for the evaluation of aerobic capacity.
Measured: After 6-week training and 3 months after 6-week training ends.
Lower extremity strength
To determine lower extremity strength and functional mobility, the 30-second Sit-Up Test will be used in the chair.
Measured: After 6-week training and 3 months after 6-week training ends.
Total quality of life score evaluated by Chronic Venous Disease Quality of Life Questionnaire
The score will be evaluated using Chronic Venous Disease Quality of Life Questionnaire. Each question is scored on a 5-item Likert scale. Higher scores indicate better quality of life.
Measured: After 6-week training and 3 months after 6-week training ends.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start15 Sep 2023
- Primary completion30 Jun 2024
- Study completion30 Dec 2024
Why it stopped: Patients could not be reached for long-term follow-up.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Democracy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulsah Bargi, Izmir Democracy University
- Investigators
- GÜLŞAH BARĞI, Assoc. Dr., Study director, Izmir Democracy UniversityÖZLEM ÇİNAR ÖZDEMİR, Assoc. Dr., Principal investigator, Izmir Democracy UniversityCEMRE GÖRÜNMEZOĞLU, MSc, Principal investigator, Izmir Democracy UniversityDÜNDAR ÖZALP KARABAY, Prof. Dr., Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982405
- Sponsor's protocol ID
- Long effects of IMT
- Status last verified
- May 2025
- First submitted
- 28 Jul 2023
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- 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 35710091Weiss RA, Munavalli G. Endovenous ablation of truncal veins. Semin Cutan Med Surg. 2005 Dec;24(4):193-9. doi: 10.1016/j.sder.2005.10.006.
PubMed 16387263Eberhardt RT, Raffetto JD. Chronic venous insufficiency. Circulation. 2005 May 10;111(18):2398-409. doi: 10.1161/01.CIR.0000164199.72440.08. No abstract available.
PubMed 15883226
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects of Inspiratory Muscle Training in Individuals With Chronic Venous Insufficiency
- ClinicalTrials.gov ID
- NCT05982405
- Acronym / sponsor ID
- Long effects of IMT
- Conditions
- Chronic Venous Insufficiency
- Keywords
- Venous Insufficiency, pain, edema, respiratory function tests, maximal respiratory pressures, exercise capacity, quality of life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patients could not be reached for long-term follow-up.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 8 Aug 2023 (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 long-term effectiveness of inspiratory muscle training, which is known in the literature to help venous return by increasing the pump effect of the diaphragm muscle, remains unclear in individuals with chronic venous insufficiency. For this reason, in this study, it was aimed to investigate the long-term results of inspiratory muscle training in individuals with chronic venous insufficiency.
Detailed description
Initial treatment of chronic venous insufficiency (CVI) includes conservative methods such as reducing symptoms and helping to prevent secondary problems and disease progression. If conservative methods fail, further treatments based on anatomical and physiological pathophysiological features should be applied. Treatment of CVI ranges from simple compression stockings to very complicated venous reconstructions. Physiotherapy applications also have an important place in the treatment of CVI and contain patient education, complex decongestive physiotherapy, intermittent pneumatic compression, compression garment, venous exercise programs, biomechanical stimulation therapy, proprioceptive neuromuscular facilitation, relaxation techniques and hydrotherapy methods.
Researches investigating the effectiveness of new physiotherapy applications in CVI are very limited. In one of these publications, the effects of inspiratory muscle training (IMT) and calf muscle exercise training (CMET) applied in addition to compression therapy (CT) on quality of life (QoL), venous filling time, disease severity, pain, edema, range of motion, muscle strength and functionality were investigated newly. IMT and CT were applied in group 1, CMET and CT were applied in group 2, and only CT was applied in group 3. As a result, groups of 1 and 2 showed more improvement in these outcomes compared to other groups. Acute effects of inspiratory muscle training in CVI was only shown in this study. The long-term effectiveness of inspiratory muscle training is still unclear in individuals with CVI. Therefore, this study aimed to investigate the long-term results of inspiratory muscle training in individuals with CVI.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training group | Experimental | Other: Training group: Inspiratory muscle trainingThe individuals in the training group will be performed inspiratory muscle training using an inspiratory muscle training device (PowerBreathe®) at 30-50% of the maximal inspiratory pressure. |
| Control group | Sham comparator | Other: Control group: Thoracic expansion exerciseIndividuals in the control group will be performed thoracic expansion exercises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Volunteering to participate in the study
- Diagnosed with chronic venous insufficiency using duplex ultrasound and being under standard medical treatment follow-up
- Being in one of the C1, C2, C3, C4 or C5 stages according to the Clinical, Etiology, Anatomy and Pathophysiology (CEAP) classification
Key exclusion criteria (6 listed)
- Acute deep vein thrombosis, active ulcers, psychiatric disorder requiring prior vessel ablation and/or prescription drug therapy,
- Any history of chronic disease or deep vein thrombosis that may interfere with exercise capacity measurement,
- Having SARS-CoV-2 (COVID-19) or any acute infection,
- Being pregnant,
- History of arterial disease,
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 |
|---|---|---|
| Training group: Inspiratory muscle trainingAlso: Experimental: Training groupThe individuals in the training group will be performed inspiratory muscle training at 30-50% of the maximal inspiratory pressure. Inspiratory muscle training will be done using an inspiratory muscle training device (PowerBreathe®) that works with the threshold loading principle. Inspiratory muscle training will be done for 15 minutes per a session, 2 times per a day or, if tolerated, 30 minutes per a day and 1 time per a day, 5-7 days/week (one session under the supervision and the others at home), for a total of 6 weeks. Applications made at home will be followed with a diary. | Other | Training group |
| Control group: Thoracic expansion exerciseAlso: Sham Comparator: Control groupIndividuals in the control group will be performed thoracic expansion exercises. Thoracic expansion exercises will be applied to individuals in an upright sitting position. In this position, individuals will place their hands on their lower ribs and then perform the cycle of "deep breathing + holding the deep breath for 3 seconds + slowly emptying all the breath" 3 times in a row. After this cycle, individuals will be asked to rest by taking 3-4 calm breaths. Immediately after, the individual will be asked to repeat the same cycle and repeat the cycle with calm breaths and rest until it reaches 10 repetitions. The individual will do this session 4 times a day. Individuals will do the first session of breathing exercises under supervision. In this way, incorrect exercise will be prevented. Other breathing exercise sessions will be done by individuals as a home program every day and 4 sessions a day during 6 weeks. | Other | Control group |
Primary outcome
Maximal inspiratory pressure (MIP)
Time frame: After 6-week training and 3 months after 6-week training ends.
The MIP which shows respiratory muscle strength will be evaluated using a portable mouth pressure measuring device based on American Thoracic Society and European Respiratory Society criteria.
10 secondary outcomes
Maximal expiratory pressure (MEP)
Time frame: After 6-week training and 3 months after 6-week training ends.
Forced vital capacity (FVC)
Time frame: After 6-week training and 3 months after 6-week training ends.
Forced expiratory volume in the first second (FEV1)
Time frame: After 6-week training and 3 months after 6-week training ends.
FEV1 / FVC
Time frame: After 6-week training and 3 months after 6-week training ends.
Flow rate 25-75% of forced expiratory volume (FEF 25-75%)
Time frame: After 6-week training and 3 months after 6-week training ends.
Peak flow rate (PEF)
Time frame: After 6-week training and 3 months after 6-week training ends.
Pain Intensity measured with the Numerical Rating Scale.
Time frame: After 6-week training and 3 months after 6-week training ends.
Aerobic capacity
Time frame: After 6-week training and 3 months after 6-week training ends.
Lower extremity strength
Time frame: After 6-week training and 3 months after 6-week training ends.
Total quality of life score evaluated by Chronic Venous Disease Quality of Life Questionnaire
Time frame: After 6-week training and 3 months after 6-week training ends.
Results and safety
The study was stopped early (reason given: Patients could not be reached for long-term follow-up.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Background: 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.
- Background: PubMed 16387263Weiss RA, Munavalli G. Endovenous ablation of truncal veins. Semin Cutan Med Surg. 2005 Dec;24(4):193-9. doi: 10.1016/j.sder.2005.10.006.
- Background: PubMed 15883226Eberhardt RT, Raffetto JD. Chronic venous insufficiency. Circulation. 2005 May 10;111(18):2398-409. doi: 10.1161/01.CIR.0000164199.72440.08. No abstract available.
- 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.
GÜLŞAH BARĞI, Assoc. Dr. study director
Izmir Democracy University
ÖZLEM ÇİNAR ÖZDEMİR, Assoc. Dr. principal investigator
Izmir Democracy University
CEMRE GÖRÜNMEZOĞLU, MSc principal investigator
Izmir Democracy University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training group: Inspiratory muscle training in people with Chronic Venous Insufficiency, run by Izmir Democracy University 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 4 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: stopped early, as of the sponsor's last update on 18 May 2025. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Patients could not be reached for long-term follow-up.). Results are not available in the source record.
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?
Maximal inspiratory pressure (MIP) (time frame: After 6-week training and 3 months after 6-week training ends.). 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 NCT05982405, which also lists 3 linked publications.
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 2025.