Chronic Venous InsufficiencyNCT05993650
Inspiratory Muscle Training in Chronic Venous Diseases
A study testing Inspiratuar Muscle Training Group and Thoracic Expansion Exercise Group in people with Chronic Venous Insufficiency, run by Izmir Democracy University at 1 site in Turkey (Türkiye).
Trial summary
There is insufficient evidence of inspiratory muscle training on venous function, clinical severity, symptoms and functional capacity and quality of life in CVI patients. Therefore, in the study, the investigators aimed to determine the effectiveness of inspiratory muscle training in individuals with chronic venous… 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?
- Inspiratuar Muscle Training Group and Thoracic Expansion Exercise Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jul 2023to 24 Jul 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
- Being diagnosed with CVI
- Being between C1-C5 according to the 'Clinical, Etiologic, Anatomic, Pathophysiologic' (CEAP) scale,
- To accept to participate in the study,
Who cannot join
- Arterial diseases,
- Presence of advanced cardiorespiratory diseases,
- Having orthopedic and neurological disorders that may affect walking,
- Presence of acute ulcer (< 3 months) and diabetic ulcers,
- Being pregnant.
- Having a history of deep vein thrombosis,
- Having undergone venous system surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Democracy University
Izmir, Karabağlar/İZMİR, 35140
About this study
Official title: Inspiratory Muscle Training in Individuals With Chronic Venous Disease : A Randomized Controlled Study
There is insufficient evidence of inspiratory muscle training on venous function, clinical severity, symptoms and functional capacity and quality of life in CVI patients. Therefore, in the study, the investigators aimed to determine the effectiveness of inspiratory muscle training in individuals with chronic venous insufficiency.
Read the detailed description
Chronic venous insufficiency (CVI) is defined as a very common condition that affects the venous system in the lower extremities, including various pathologies and subjective symptoms such as pain, cramps, restlessness in the legs, edema, itching and skin changes. CVI is a disease that develops due to venous hypertension in the lower extremities, resulting in impaired turbulent flow fields, venous distention, free radical formation and inflammation. In addition to being a cosmetic problem, symptoms such as pain, itching, burning, tingling, night cramps, edema, skin changes and venous ulcers in chronic cases can be seen. It is seen between 5-30% in the adult population. CVI affects 40% of the general population. Because of its high prevalence, chronic venous diseases are a common condition that causes major socioeconomic impacts. According to the studies; it has been observed that 32% of women and 40% of men have varicose veins, and any type of venous disease affects 40-50% of men and 50-55% of.
The main clinical features of CVI are dilated veins, edema, leg pain, muscle cramps, and cutaneous changes in the leg. Edema begins in the perimalleolar region and ascendes up the leg. Leg restlessness is often described as heaviness or pain after prolonged standing and is relieved by leg elevation. This discomfort is caused by increased intracompartmental and subcutaneous volume and pressure. Venous valves and venous pump are the two major determinants of venous flow. Venous valves play a role in directing the flow from the superficial system to the deep system and in its progression from the proximal veins to the distal veins.
Venous function is reflected in venous return, venous resistance, and its effects on cardiac output. Venous filling time is a parameter of venous function and is shortened as a result of valve insufficiency, vessel wall enlargement and inability of muscle pumps to work actively. The calf muscles compress the deep intramuscular veins, diverting blood flow from the veins to the heart. This mechanism depends on talocrural mobility and the force of contraction of the calf muscles. However, muscle pump dysfunction is not limited to the calf, but also includes inspiratory muscle dysfunction, such as when the diaphragm allows greater blood flow to the heart from the lower extremities, creating a suction effect on the inferior vena cava during inspiration and expiration. It has been shown that the respiratory cycle affects the increase of deep inspiration and the flow rate of the femoral vein and venous return in healthy individuals. When inspiratory muscle strength is insufficient, blood flow in the leg veins will decrease, increasing vascular resistance and thus systemic refill can be reduced. Increasing the muscle strength of inspiration with inspiratory muscle training is considered to increase venous return and improve symptoms of CVI, including pain and edema. However, there is insufficient evidence of inspiratory muscle training on venous function, clinical severity, symptoms and functional capacity and quality of life in CVI patients. Therefore, in the study, the investigators aimed to determine the effectiveness of inspiratory muscle training in individuals with chronic venous insufficiency.
- Conditions
- Chronic Venous Insufficiency
- Being tested
- Inspiratuar Muscle Training Group, Thoracic Expansion Exercise Group
- Keywords
- chronic venous insufficiency, maximal respiratory pressures, respiratory function tests, exercise capacity, edema, pain, quality of life
- Medical subject headings
- Edema, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratuar Muscle Training GroupOther
Also called Inspiratuar Muscle Training
Inspiratory muscle training will be done for 15 minutes/session, 2 times/day, or 30 minutes/day if tolerated, 5-7 days/week (one under supervision and others at home), for a total of 6 weeks. Applications made at home will be followed with a diary. Inspiratory muscle training will be performed using an inspiratory muscle training device (PowerBreathe®) working with the threshold loading principle.In the first week of the training, 30-50% of the maximal inspiratory pressure (MIP) measured in the initial evaluation of the individual will be adjusted according to the patient's tolerance, and inspiratory muscle training will be performed. Respiratory muscle strength measurement will be repeated every week in the individuals in the training group. 30-50% of the new MIP value obtained will be calculated and adjusted by calculating the new training workload for the application of inspiratory muscle training in the following weeks
Thoracic Expansion Exercise GroupOther
Individuals in this group will be given thoracic expansion exercises and patient education. 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 "inhale a deep breathing + holding the deep breath for 3 seconds + slowly exhale 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: Inspiratuar Muscle Training Group |
| Control Group | Sham comparator | Individuals in this group will be given thoracic expansion exercises and patient education. Receives: Other: Thoracic Expansion Exercise Group |
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
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
Forced vital capacity (FVC)
Pulmonary function (Forced vital capacity (FVC)) will be evaluated with a spirometer. In the study, measurements will be made using the Cosmed Omnia microQuark 1.5 (Cosmed, Rome, Italy) device. Considering that dizziness may occur during forced expiration, measurements will be made while individuals are in a sitting position. While participants are sitting in a comfortable position in a chair with a backrest, nose clip will be attached and they will be asked to bite the mouthpieces with their teeth and close their lips in a way that does not allow air to escape. The tests will be performed at least 3 times by the participants and care will be taken to ensure that the expiration time is at least 6 seconds and the plateau time is 1 second. Due to the device software that records all three data, it saves the average of the two best data and processes it as a value.
Measured: After 6-week training.
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.
FEV1 / FVC
Pulmonary function (FEV1 / FVC) will be evaluated with a spirometer.
Measured: After 6-week training.
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.
Peak flow rate (PEF)
Pulmonary function (Peak flow rate (PEF)) will be evaluated with a spirometer.
Measured: After 6-week training.
Aerobic capacity assessment
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.
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.
Edema assessment
It is planned to evaluate the edema in the lower extremity by measuring the circumference with a tape measure. Both legs will be recorded separately and the difference will be calculated. A bendable, non-elastic, 7 mm wide standard tape measure with an accuracy of 0.1 cm will be used for circumference measurements. The "0" (zero) end of the tape measure will be wrapped around the area to be measured, with the "0" (zero) end in the left hand and the other end in the right hand, and the number above the "0" (zero) point will be noted
Measured: After 6-week training.
Quality of life assessment
Quality of life will be evaluated using Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20).CIVIQ-20 is a quality of life survey that contains 20 questions and is specific for Chronic Venous Insufficiency, encompassing four quality of life domains: physical, psychological and social impairment and the severity of pain. There is a 5-point answer rating in each question, according to which higher scores indicate more severe impairment. There is a score varying from 0 to 100 in the CIVIQ-20 where the higher scores indicate better quality of life.
Measured: After 6-week training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start20 Jul 2023
- Primary completion10 Jul 2024
- Study completion24 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Model description
- Assessment
- 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, Özlem Çınar Özdemir, Izmir Democracy University
- Investigators
- Özlem Çinar Özdemir, Study director, Izmir Democracy UniversityGülşah BARĞI, Principal investigator, Izmir Democracy UniversityCemre GÖRÜNMEZOĞLU, MSc, Principal investigator, Izmir Democracy UniversityDündar Özalp KARABAY, Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993650
- Sponsor's protocol ID
- IMT in Venous Diseases
- Status last verified
- Jan 2025
- First submitted
- 31 Jul 2023
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
OZDEMIR, Özlem Çınar; BAKAR, Yeşim; SÜRMELI, Mahmut. Kronik Venöz Yetmezlikte Ağrı, Yaşam Kalitesi Ve Depresyon Arasındaki İlişkinin İncelenmesi. Konuralp Medical Journal/Konuralp Tip Dergisi, 2017, 9.2.
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 35710091Kwon OY, Jung DY, Kim Y, Cho SH, Yi CH. Effects of ankle exercise combined with deep breathing on blood flow velocity in the femoral vein. Aust J Physiother. 2003;49(4):253-8. doi: 10.1016/s0004-9514(14)60141-0.
PubMed 14632624Ozdemir OC, Tonga E, Tekindal A, Bakar Y. Cross-cultural adaptation, reliability and validity of the Turkish version of the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20). Springerplus. 2016 Mar 31;5:381. doi: 10.1186/s40064-016-2039-2. eCollection 2016.
PubMed 27066388
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Muscle Training in Individuals With Chronic Venous Disease : A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05993650
- Acronym / sponsor ID
- IMT in Venous Diseases
- Conditions
- Chronic Venous Insufficiency
- Keywords
- chronic venous insufficiency, maximal respiratory pressures, respiratory function tests, exercise capacity, edema, pain, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Izmir Democracy UniversityUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 24 Jul 2024 (actual)
- First posted
- 15 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.
There is insufficient evidence of inspiratory muscle training on venous function, clinical severity, symptoms and functional capacity and quality of life in CVI patients. Therefore, in the study, the investigators aimed to determine the effectiveness of inspiratory muscle training in individuals with chronic venous insufficiency.
Detailed description
Chronic venous insufficiency (CVI) is defined as a very common condition that affects the venous system in the lower extremities, including various pathologies and subjective symptoms such as pain, cramps, restlessness in the legs, edema, itching and skin changes. CVI is a disease that develops due to venous hypertension in the lower extremities, resulting in impaired turbulent flow fields, venous distention, free radical formation and inflammation. In addition to being a cosmetic problem, symptoms such as pain, itching, burning, tingling, night cramps, edema, skin changes and venous ulcers in chronic cases can be seen. It is seen between 5-30% in the adult population. CVI affects 40% of the general population. Because of its high prevalence, chronic venous diseases are a common condition that causes major socioeconomic impacts. According to the studies; it has been observed that 32% of women and 40% of men have varicose veins, and any type of venous disease affects 40-50% of men and 50-55% of.
The main clinical features of CVI are dilated veins, edema, leg pain, muscle cramps, and cutaneous changes in the leg. Edema begins in the perimalleolar region and ascendes up the leg. Leg restlessness is often described as heaviness or pain after prolonged standing and is relieved by leg elevation. This discomfort is caused by increased intracompartmental and subcutaneous volume and pressure. Venous valves and venous pump are the two major determinants of venous flow. Venous valves play a role in directing the flow from the superficial system to the deep system and in its progression from the proximal veins to the distal veins.
Venous function is reflected in venous return, venous resistance, and its effects on cardiac output. Venous filling time is a parameter of venous function and is shortened as a result of valve insufficiency, vessel wall enlargement and inability of muscle pumps to work actively. The calf muscles compress the deep intramuscular veins, diverting blood flow from the veins to the heart. This mechanism depends on talocrural mobility and the force of contraction of the calf muscles. However, muscle pump dysfunction is not limited to the calf, but also includes inspiratory muscle dysfunction, such as when the diaphragm allows greater blood flow to the heart from the lower extremities, creating a suction effect on the inferior vena cava during inspiration and expiration. It has been shown that the respiratory cycle affects the increase of deep inspiration and the flow rate of the femoral vein and venous return in healthy individuals. When inspiratory muscle strength is insufficient, blood flow in the leg veins will decrease, increasing vascular resistance and thus systemic refill can be reduced. Increasing the muscle strength of inspiration with inspiratory muscle training is considered to increase venous return and improve symptoms of CVI, including pain and edema. However, there is insufficient evidence of inspiratory muscle training on venous function, clinical severity, symptoms and functional capacity and quality of life in CVI patients. Therefore, in the study, the investigators aimed to determine the effectiveness of inspiratory muscle training in individuals with chronic venous insufficiency.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Assessment
| Arm | Type | Receives |
|---|---|---|
| Training Group | Experimental | Other: Inspiratuar Muscle Training GroupThe 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: Thoracic Expansion Exercise GroupIndividuals in this group will be given thoracic expansion exercises and patient education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being diagnosed with CVI
- Being between C1-C5 according to the 'Clinical, Etiologic, Anatomic, Pathophysiologic' (CEAP) scale,
- To accept to participate in the study,
Key exclusion criteria (7 listed)
- Arterial diseases,
- Presence of advanced cardiorespiratory diseases,
- Having orthopedic and neurological disorders that may affect walking,
- Presence of acute ulcer (< 3 months) and diabetic ulcers,
- Being pregnant.
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 |
|---|---|---|
| Inspiratuar Muscle Training GroupAlso: Inspiratuar Muscle TrainingInspiratory muscle training will be done for 15 minutes/session, 2 times/day, or 30 minutes/day if tolerated, 5-7 days/week (one under supervision and others at home), for a total of 6 weeks. Applications made at home will be followed with a diary. Inspiratory muscle training will be performed using an inspiratory muscle training device (PowerBreathe®) working with the threshold loading principle.In the first week of the training, 30-50% of the maximal inspiratory pressure (MIP) measured in the initial evaluation of the individual will be adjusted according to the patient's tolerance, and inspiratory muscle training will be performed. Respiratory muscle strength measurement will be repeated every week in the individuals in the training group. 30-50% of the new MIP value obtained will be calculated and adjusted by calculating the new training workload for the application of inspiratory muscle training in the following weeks | Other | Training Group |
| Thoracic Expansion Exercise GroupIndividuals in this group will be given thoracic expansion exercises and patient education. 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 "inhale a deep breathing + holding the deep breath for 3 seconds + slowly exhale 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
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
Forced vital capacity (FVC)
Time frame: After 6-week training.
Forced expiratory volume in the first second (FEV1)
Time frame: After 6-week training.
FEV1 / FVC
Time frame: After 6-week training.
Flow rate 25-75% of forced expiratory volume (FEF 25-75%)
Time frame: After 6-week training.
Peak flow rate (PEF)
Time frame: After 6-week training.
Aerobic capacity assessment
Time frame: After 6-week training.
Lower extremity strength
Time frame: After 6-week training.
Edema assessment
Time frame: After 6-week training.
Quality of life assessment
Time frame: After 6-week training.
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 17 Jan 2025.
- BackgroundOZDEMIR, Özlem Çınar; BAKAR, Yeşim; SÜRMELI, Mahmut. Kronik Venöz Yetmezlikte Ağrı, Yaşam Kalitesi Ve Depresyon Arasındaki İlişkinin İncelenmesi. Konuralp Medical Journal/Konuralp Tip Dergisi, 2017, 9.2.
- 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 14632624Kwon OY, Jung DY, Kim Y, Cho SH, Yi CH. Effects of ankle exercise combined with deep breathing on blood flow velocity in the femoral vein. Aust J Physiother. 2003;49(4):253-8. doi: 10.1016/s0004-9514(14)60141-0.
- Background: PubMed 27066388Ozdemir OC, Tonga E, Tekindal A, Bakar Y. Cross-cultural adaptation, reliability and validity of the Turkish version of the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20). Springerplus. 2016 Mar 31;5:381. doi: 10.1186/s40064-016-2039-2. eCollection 2016.
- 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.
Özlem Çinar Özdemir study director
Izmir Democracy University
Gülşah BARĞI 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 Inspiratuar Muscle Training Group and Thoracic Expansion Exercise Group 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 3 inclusion and 7 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 17 Jan 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 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?
Maximal inspiratory pressure (MIP) (time frame: After 6-week training). 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 NCT05993650, which also lists 4 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 17 Jan 2025.