Breathing Pattern DisorderNCT07104357
The Effect of Inspiratory Muscle Training on Breathing Pattern and Functionality in Patients With Chronic Heart Failure.
A study testing Inspiratory muscle training in people with Breathing Pattern Disorder, run by University of West Attica.
Trial summary
The effect of inspiratory muscle training on breathing pattern and functionality in patients with chronic heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breathing Pattern Disorder
- What is being tested?
- Inspiratory muscle training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2025to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- adults aged ≥ 18 years
- diagnosis of heart failure within the previous three to twelve months
- current outpatients in a stable optimal medical regimen for at least 3 months
- able to perform inspiratory muscle training
- clinically stable, without hospital admission in the previous 3 months and without participation in any other training program in the previous 6 months
Who cannot join
- unstable angina
- recent acute myocardial infarction
- uncontrolled hypertension
- valve disease
- peripheral arterial disease
- 6MWT assessment of less than 300 meters
Show all 9Show fewer
- previous pulmonary disease (forced vital capacity <80% of predicted and/or forced expiratory volume in 1 s <70% of predicted)
- history of exercise-induced asthma
- smokers
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Inspiratory Muscle Training on Dysfunctional Breathing and Functional Ability in Patients With Chronic Heart Failure. A Study Protocol for a Randomized Controlled Trial
The effect of inspiratory muscle training on breathing pattern and functionality in patients with chronic heart failure.
Read the detailed description
The study protocol aims to examine the impact of inspiratory muscle training on dysfunctional breathing and functional ability in patients with chronic heart failure. Inspiratory muscle training is a low-cost intervention that might improve the breathing pattern, functionality and overall quality of life in patients with chronic heart failure
- Conditions
- Breathing Pattern Disorder
- Being tested
- Inspiratory muscle training
- Keywords
- inspiratory muscle training, dysfunctional breathing, functional ability, chronic heart failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingDevice
Participants will perform 20 sessions of respiratory muscle strengthening (20 minutes at 30-60% of MIP), using the Threshold Inspiratory Muscle Training device
| Study group | Role | What they receive |
|---|---|---|
| Randomized controlled trial | Experimental | The intervention group will be trained with inspiratory muscle training for 4 weeks. Inspiratory Muscle Training has been designed to enhance respiratory muscle function through targeted exercises, to strengthen the respiratory muscles, ,thereby improving overall respiratory efficiency Receives: Device: Inspiratory muscle training |
| Control group | No intervention | The control group will receive standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic Thickness
Diaphragmatic thickness measured by ultrasound is a non-invasive, widely used method to assess diaphragm structure in patients with chronic heart failure. Thickness is measured between the pleural and peritoneal lines at end-expiration and end-inspiration
Measured: From enrollment to the end of treatment at 4 weeks
Dysfunctional breathing
Dysfunctional breathing refers to abnormal breathing patterns that are often related to the heart's inability to supply blood effectively, affecting respiratory function. Dysfunctional breathing will be assessed with the Hi-Lo breathing test, an observational clinical test used to assess breathing pattern and diaphragm function. The clinician observes and palpates whether the movement is greater under the upper chest hand (Hi) or lower abdomen hand (Lo).The test is scored as "Yes" if upper chest (apical) breathing predominates and "No" if normal diaphragmatic breathing is present.
Measured: From enrollment to the end of treatment at 4 weeks
Functional ability
Functional ability refers to how well patients can perform daily activities and maintain independence despite their cardiac condition. It will be assessed with the 6-Minute Walk Test (6MWT), a simple and effective tool that evaluates the maximum distance a person can walk in six minutes. The outcome reflects the integrated response of the cardiovascular system mainly, and exercise tolerance.
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (3)
Maximal inspiratory pressure
It is a measure of the strength of inspiratory muscles, primarily the diaphragm. MIP is a reliable and reproducible measure that does not depend on the patient's respiratory flow.
Measured: From enrollment to the end of treatment at 4 weeks
Functional Dyspnea
Functional dyspnea will be measured with the Medical Research Council (MRC) Dyspnea scale, a simple grading system to evaluate the functional disability due to dyspnea. The scale ranges from 1 to 5, where 1 indicates breathlessness only with strenuous exercise and 5 indicates breathlessness that prevents leaving the house or occurs when dressing or undressing. Higher scores represent worse functional status (more severe dyspnea).
Measured: From enrollment to the end of treatment at 4 weeks
Health Related Quality of life
Quality of life will be evaluated with the Short Form Survey, a questionnaire with 12-items, that measures quality of life in terms of physical and mental health. It generates scores typically ranging from 0 to 100, with higher scores indicating better health status and quality of life.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start15 Aug 2025 (estimated)
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breathing Pattern DisorderStudies 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
- Model description
- This single-center, randomized controlled, single-blinded clinical trial is designed to investigate the effectiveness of inspiratory muscle training on breathing pattern and functional ability in patients with chronic heart failure
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of West Attica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Mitsiou, University of West Attica
- Investigators
- Irini Grammatopoulou, Phd, Post Doc, Study director, University of West Attica, Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104357
- Sponsor's protocol ID
- 51604/04-06-2025
- Status last verified
- Jul 2025
- First submitted
- 7 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Inspiratory Muscle Training on Dysfunctional Breathing and Functional Ability in Patients With Chronic Heart Failure. A Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07104357
- Acronym / sponsor ID
- 51604/04-06-2025
- Conditions
- Breathing Pattern Disorder
- Keywords
- inspiratory muscle training, dysfunctional breathing, functional ability, chronic heart failure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of West AtticaUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 5 Aug 2025 (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 effect of inspiratory muscle training on breathing pattern and functionality in patients with chronic heart failure.
Detailed description
The study protocol aims to examine the impact of inspiratory muscle training on dysfunctional breathing and functional ability in patients with chronic heart failure. Inspiratory muscle training is a low-cost intervention that might improve the breathing pattern, functionality and overall quality of life in patients with chronic heart failure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This single-center, randomized controlled, single-blinded clinical trial is designed to investigate the effectiveness of inspiratory muscle training on breathing pattern and functional ability in patients with chronic heart failure
| Arm | Type | Receives |
|---|---|---|
| Randomized controlled trial | Experimental | Device: Inspiratory muscle trainingThe intervention group will be trained with inspiratory muscle training for 4 weeks. Inspiratory Muscle Training has been designed to enhance respiratory muscle function through targeted exercises, to strengthen the respiratory muscles, ,thereby improving overall respiratory efficiency |
| Control group | No intervention | –The control group will receive standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adults aged ≥ 18 years
- diagnosis of heart failure within the previous three to twelve months
- current outpatients in a stable optimal medical regimen for at least 3 months
- able to perform inspiratory muscle training
- clinically stable, without hospital admission in the previous 3 months and without participation in any other training program in the previous 6 months
Key exclusion criteria (9 listed)
- unstable angina
- recent acute myocardial infarction
- uncontrolled hypertension
- valve disease
- peripheral 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 |
|---|---|---|
| Inspiratory muscle trainingParticipants will perform 20 sessions of respiratory muscle strengthening (20 minutes at 30-60% of MIP), using the Threshold Inspiratory Muscle Training device | Device | Randomized controlled trial |
Primary outcome
Diaphragmatic Thickness
Time frame: From enrollment to the end of treatment at 4 weeks
Diaphragmatic thickness measured by ultrasound is a non-invasive, widely used method to assess diaphragm structure in patients with chronic heart failure. Thickness is measured between the pleural and peritoneal lines at end-expiration and end-inspiration
Dysfunctional breathing
Time frame: From enrollment to the end of treatment at 4 weeks
Dysfunctional breathing refers to abnormal breathing patterns that are often related to the heart's inability to supply blood effectively, affecting respiratory function. Dysfunctional breathing will be assessed with the Hi-Lo breathing test, an observational clinical test used to assess breathing pattern and diaphragm function. The clinician observes and palpates whether the movement is greater under the upper chest hand (Hi) or lower abdomen hand (Lo).The test is scored as "Yes" if upper chest (apical) breathing predominates and "No" if normal diaphragmatic breathing is present.
Functional ability
Time frame: From enrollment to the end of treatment at 4 weeks
Functional ability refers to how well patients can perform daily activities and maintain independence despite their cardiac condition. It will be assessed with the 6-Minute Walk Test (6MWT), a simple and effective tool that evaluates the maximum distance a person can walk in six minutes. The outcome reflects the integrated response of the cardiovascular system mainly, and exercise tolerance.
3 secondary outcomes
Maximal inspiratory pressure
Time frame: From enrollment to the end of treatment at 4 weeks
Functional Dyspnea
Time frame: From enrollment to the end of treatment at 4 weeks
Health Related Quality of life
Time frame: From enrollment to the end of treatment at 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- 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.
Irini Grammatopoulou, Phd, Post Doc study director
University of West Attica, Athens, Greece
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training in people with Breathing Pattern Disorder, run by University of West Attica.
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 9 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: opening soon, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Georgios Mitsiou, Phd (00306947888331, gmitsiou@uniwa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragmatic Thickness (time frame: From enrollment to the end of treatment at 4 weeks). The study lists 3 primary outcomes in all. 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 5 Aug 2025.