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

NCT07131397 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-08-20

No results posted yet for this study

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).

Conditions

  • Gastro Esophageal Reflux

Interventions

DEVICE

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.

DEVICE

Sham Inspiratory Muscle Training

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

Sponsors & Collaborators

  • University of West Attica

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-08
Primary Completion
2027-07-30
Completion
2027-12-30

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07131397 on ClinicalTrials.gov