Gastro Esophageal RefluxNCT07131397
The Effect of Inspiratory Muscle Training in People With Gastroesophageal Reflux Disease
A study testing Inspiratory Muscle Traing in people with Gastro Esophageal Reflux, run by University of West Attica at 1 site in Greece.
Trial summary
The present Randomized Control Trial will be a single centric, two arm parallel equivalence randomized controlled. Participants will be assigned to either the Inspiratory MuscleTraining (IMT) group (investigation) or to Sham IMT group (control). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastro Esophageal Reflux
- What is being tested?
- Inspiratory Muscle Traing
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteGreece
- Study dates
- 8 Jan 2025to 30 Dec 2027
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: people diagnosed with GERD or had a score of more than 8 on the Gastroesophageal Reflux Disease Questionnaire
Exclusion Criteria: systemic connective tissue diseases, mental disorders, stomach or duodenal surgery, tuberculosis, pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
University of West Attica
Athens, Attica
Irini Patsaki, PhD, +306942064363, ipatsaki@uniwa.gr
About this study
Official title: The Effect of Inspiratory Muscle Training on Inspiratory Strength in People With Gastroesophageal Reflux Disease.
The present Randomized Control Trial will be a single centric, two arm parallel equivalence randomized controlled. Participants will be assigned to either the Inspiratory MuscleTraining (IMT) group (investigation) or to Sham IMT group (control). The assessment times were three (3) before the start of the program (baseline-T1), immediately after the 3 months of the main exercise program (end of the main program-T2) and 6 months after (end of follow up-T3).
The measurements included: A. By measuring the Maximum Inspiratory Pressure (MIP) (Micro RPM) B. By measuring the Maximum Dynamic Inspiratory Pressure s-index (Powerbrethe K5)
Read more
The following instruments were included in the secondary outcome measures:
- Recurrent Gastroesophageal Reflux Disease Questionnaire (measurement of symptom frequency-RDQ Questionaire).
- Gastroesophageal Reflux Disease-Related Quality of Life Questionnaire (Quality of Life Measure-Reflux Qual short form questionnaire).
Read the detailed description
Background: Gastroesophageal reflux disease (GERD) is multifactorial and affects an increasing number of people. Its main cause is found in the antireflux valve mechanism of the gastroesophageal junction. This consists of two sphincters, the lower oesophageal and the diaphragmatic. The disease has been related to diaphragm dysfunction, either due to the de-coordination of the diaphragms' contractility or due to decreased strength. This study was designed to evaluate the effect of inspiratory muscle training on inspiratory strength in people with gastroesophageal reflux disease.
Objective: To evaluate the effect of a IMT program in maximal inspiratory pressure, maximal dynamic inspiratory pressure, gerd symptoms and quality of life in GERD patients.
Methods: Adults with diagnosed gastroesophageal reflux disease (n=30) or had a score of more than 8 on the Gastroesophageal Reflux Disease Questionnaire will be recruited from invitations that will be made through the social media. The volunteers who meet the inclusion criteria will be randomly allocated to two groups: (a) the experimental group (n = 15) that will receive 36 sessions inspiratory muscle training with tapered flow resistive loading at 40% of maximum inspiratory pressure. Each week there will be a gradual increase in resistance by 10% of the initial maximum inspiratory pressure. (b) Τhe control group (n = 15) that will receive 36 sessions inspiratory muscle training with a constant resistance load of 7cmH20 (sham group). Both groups will perform 3 sessions per week (1 set of 30 repetitions). Measurements will occur at three time points: before the initiation of treatment sessions (week 0), three months from the beginning of the trial (week 36) and 6 months after the end of the program. The main outcomes will be the maximal respiratory pressures (digital pressure manometer), maximal dynamic inspiratory pressure (tapered flow resistance device) with secondary outcomes the gerd symptoms (gerd-q questionnaire) and quality of life (Reflux Qual short form questionnaire).
Anticipated Results: IMT is expected to increased Mip, S-Index, improve Reflux Symptoms and quality of life, mitigate the impact of gerd in the participants' health and daily life compared to standard care.
Conclusion: This trial will provide novel insights into IMT's role in symptoms prevention for GERD patients, addressing a critical gap in holistic disease management.
- Conditions
- Gastro Esophageal Reflux
- Being tested
- Inspiratory Muscle Traing, Sham Inspiratory Muscle Training
- Keywords
- Inspiratory Muscle Training, Gastroesophageal Reflux Disease, Antireflux valve, Maximal Inspiratory Pressure
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle TraingDevice
IMT will be performed by applying resistance at 40% of the maximum inspiratory pressure (1 set of 30 repetitions 30 breaths per session). Each week there will be a gradual increase in resistance by 10% of the initial maximum inspiratory pressure.
Sham Inspiratory Muscle TrainingDevice
Inspiratory muscle training will be applied with a constant resistance load of 7cmH20
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory Muscle Training | Experimental | Inspiratory muscle training will be applied with the K5 Power Breath trainer. The exercise will be performed by applying resistance at 40% of the maximum inspiratory pressure (1 set of 30 repetitions 30 breaths per session). Each week there will be a gradual increase in resistance by 10% of the initial maximum inspiratory pressure. Receives: Device: Inspiratory Muscle Traing |
| Control | Sham comparator | Inspiratory muscle training will be applied with a constant resistance load of 7cmH20. Receives: Device: Sham Inspiratory Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Inspiratory Pressure
Measured: the start of the program (baseline-T1), immediately after the 3 months of the main exercise program (end of the main program-T2) and 6 months after (end of follow up-T3)
Secondary outcomes (3)
Maximum Dynamic Inspiratory Pressure s-index
Measured: the start of the program (baseline-T1), immediately after the 3 months of the main exercise program (end of the main program-T2) and 6 months after (end of follow up-T3)
Gastroesophageal Reflux Disease Questionnaire
Measured: Before the start of the program (baseline-T1), immediately after the 3 months of the main exercise program (end of the main program-T2) and 6 months after (end of follow up-T3).
Gastroesophageal Reflux Disease-Related Quality of Life Questionnaire
Measured: Before the start of the program (baseline-T1), immediately after the 3 months of the main exercise program (end of the main program-T2) and 6 months after (end of follow up-T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start8 Jan 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion30 Dec 2027 (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 Gastro Esophageal RefluxStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of West Attica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, IRINI PATSAKI, University of West Attica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131397
- Sponsor's protocol ID
- 10545
- Status last verified
- Aug 2025
- First submitted
- 10 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Syropoulos S, Moutzouri M, Grammatopoulou E, Patsaki I. Impact of Inspiratory Muscle Training in Individuals with Gastroesophageal Reflux Disease: A Randomized Controlled Trial Protocol. Methods Protoc. 2026 Feb 27;9(2):32. doi: 10.3390/mps9020032.
PubMed 41874149
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Inspiratory Muscle Training on Inspiratory Strength in People With Gastroesophageal Reflux Disease.
- ClinicalTrials.gov ID
- NCT07131397
- Acronym / sponsor ID
- 10545
- Conditions
- Gastro Esophageal Reflux
- Keywords
- Inspiratory Muscle Training, Gastroesophageal Reflux Disease, Antireflux valve, Maximal Inspiratory Pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of West AtticaUniversity, hospital or other
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 20 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 present Randomized Control Trial will be a single centric, two arm parallel equivalence randomized controlled. Participants will be assigned to either the Inspiratory MuscleTraining (IMT) group (investigation) or to Sham IMT group (control). The assessment times were three (3) before the start of the program (baseline-T1), immediately after the 3 months of the main exercise program (end of the main program-T2) and 6 months after (end of follow up-T3).
The measurements included: A. By measuring the Maximum Inspiratory Pressure (MIP) (Micro RPM) B. By measuring the Maximum Dynamic Inspiratory Pressure s-index (Powerbrethe K5)
The following instruments were included in the secondary outcome measures:
- Recurrent Gastroesophageal Reflux Disease Questionnaire (measurement of symptom frequency-RDQ Questionaire).
- Gastroesophageal Reflux Disease-Related Quality of Life Questionnaire (Quality of Life Measure-Reflux Qual short form questionnaire).
Detailed description
Background: Gastroesophageal reflux disease (GERD) is multifactorial and affects an increasing number of people. Its main cause is found in the antireflux valve mechanism of the gastroesophageal junction. This consists of two sphincters, the lower oesophageal and the diaphragmatic. The disease has been related to diaphragm dysfunction, either due to the de-coordination of the diaphragms' contractility or due to decreased strength. This study was designed to evaluate the effect of inspiratory muscle training on inspiratory strength in people with gastroesophageal reflux disease.
Objective: To evaluate the effect of a IMT program in maximal inspiratory pressure, maximal dynamic inspiratory pressure, gerd symptoms and quality of life in GERD patients.
Methods: Adults with diagnosed gastroesophageal reflux disease (n=30) or had a score of more than 8 on the Gastroesophageal Reflux Disease Questionnaire will be recruited from invitations that will be made through the social media. The volunteers who meet the inclusion criteria will be randomly allocated to two groups: (a) the experimental group (n = 15) that will receive 36 sessions inspiratory muscle training with tapered flow resistive loading at 40% of maximum inspiratory pressure. Each week there will be a gradual increase in resistance by 10% of the initial maximum inspiratory pressure. (b) Τhe control group (n = 15) that will receive 36 sessions inspiratory muscle training with a constant resistance load of 7cmH20 (sham group). Both groups will perform 3 sessions per week (1 set of 30 repetitions). Measurements will occur at three time points: before the initiation of treatment sessions (week 0), three months from the beginning of the trial (week 36) and 6 months after the end of the program. The main outcomes will be the maximal respiratory pressures (digital pressure manometer), maximal dynamic inspiratory pressure (tapered flow resistance device) with secondary outcomes the gerd symptoms (gerd-q questionnaire) and quality of life (Reflux Qual short form questionnaire).
Anticipated Results: IMT is expected to increased Mip, S-Index, improve Reflux Symptoms and quality of life, mitigate the impact of gerd in the participants' health and daily life compared to standard care.
Conclusion: This trial will provide novel insights into IMT's role in symptoms prevention for GERD patients, addressing a critical gap in holistic disease management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Training | Experimental | Device: Inspiratory Muscle TraingInspiratory muscle training will be applied with the K5 Power Breath trainer. The exercise will be performed by applying resistance at 40% of the maximum inspiratory pressure (1 set of 30 repetitions 30 breaths per session). Each week there will be a gradual increase in resistance by 10% of the initial maximum inspiratory pressure. |
| Control | Sham comparator | Device: Sham Inspiratory Muscle TrainingInspiratory muscle training will be applied with a constant resistance load of 7cmH20. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 TraingIMT will be performed by applying resistance at 40% of the maximum inspiratory pressure (1 set of 30 repetitions 30 breaths per session). Each week there will be a gradual increase in resistance by 10% of the initial maximum inspiratory pressure. | Device | Inspiratory Muscle Training |
| Sham Inspiratory Muscle TrainingInspiratory muscle training will be applied with a constant resistance load of 7cmH20 | Device | Control |
Primary outcome
Maximal Inspiratory Pressure
Time frame: the start of the program (baseline-T1), immediately after the 3 months of the main exercise program (end of the main program-T2) and 6 months after (end of follow up-T3)
3 secondary outcomes
Maximum Dynamic Inspiratory Pressure s-index
Time frame: the start of the program (baseline-T1), immediately after the 3 months of the main exercise program (end of the main program-T2) and 6 months after (end of follow up-T3)
Gastroesophageal Reflux Disease Questionnaire
Time frame: Before the start of the program (baseline-T1), immediately after the 3 months of the main exercise program (end of the main program-T2) and 6 months after (end of follow up-T3).
Gastroesophageal Reflux Disease-Related Quality of Life Questionnaire
Time frame: Before the start of the program (baseline-T1), immediately after the 3 months of the main exercise program (end of the main program-T2) and 6 months after (end of follow up-T3).
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 20 Aug 2025.
- Derived from this study: PubMed 41874149Syropoulos S, Moutzouri M, Grammatopoulou E, Patsaki I. Impact of Inspiratory Muscle Training in Individuals with Gastroesophageal Reflux Disease: A Randomized Controlled Trial Protocol. Methods Protoc. 2026 Feb 27;9(2):32. doi: 10.3390/mps9020032.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Traing in people with Gastro Esophageal Reflux, run by University of West Attica at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 20 Aug 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 Greece. 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?
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 Irini Patsaki, PhD (+306942064363, ipatsaki@uniwa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Inspiratory Pressure (time frame: the start of the program (baseline-T1), immediately after the 3 months of the main exercise program (end of the main program-T2) and 6 months after (end of follow up-T3)). 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 NCT07131397, 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 20 Aug 2025.