The Effect of Inspiratory Muscle Training in People With Gastroesophageal Reflux Disease

NCT ID: NCT07131397

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-08
• Study Completion Date: 2027-12-30

Brief 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). 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.

Conditions

Gastro Esophageal Reflux

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Inspiratory Muscle Training

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.

Group Type: EXPERIMENTAL

Inspiratory Muscle Traing

Intervention Type: DEVICE

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.

Control

Inspiratory muscle training will be applied with a constant resistance load of 7cmH20.

Group Type: SHAM_COMPARATOR

Sham Inspiratory Muscle Training

Intervention Type: DEVICE

Inspiratory muscle training will be applied with a constant resistance load of 7cmH20

Interventions

Inspiratory Muscle Traing

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.

Intervention Type: DEVICE

Sham Inspiratory Muscle Training

Inspiratory muscle training will be applied with a constant resistance load of 7cmH20

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of West Attica

OTHER

Sponsor Role: lead

Responsible Party

IRINI PATSAKI

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of West Attica

Athens, Attica, Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

Irini Patsaki, PhD

Role: CONTACT

ipatsaki@uniwa.gr

+306942064363

Facility Contacts

Irini Patsaki, PhD

Role: primary

ipatsaki@uniwa.gr

+306942064363

Other Identifiers

10545

Identifier Type: -

Identifier Source: org_study_id