NCT07131397

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress45%
Jan 2025Dec 2027

Study Start

First participant enrolled

January 8, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 20, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

August 20, 2025

Status Verified

August 1, 2025

Enrollment Period

2.6 years

First QC Date

August 10, 2025

Last Update Submit

August 15, 2025

Conditions

Gastro Esophageal Reflux

Keywords

Inspiratory Muscle TrainingGastroesophageal Reflux DiseaseAntireflux valveMaximal Inspiratory Pressure

Outcome Measures

Primary Outcomes (1)

  • Maximal Inspiratory Pressure

    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

    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

    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

    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).

Study Arms (2)

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.

Device: Inspiratory Muscle Traing

Control

SHAM COMPARATOR

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

Device: Sham Inspiratory Muscle Training

Interventions

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.

Inspiratory Muscle Training
Sham Inspiratory Muscle TrainingDEVICE

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

Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of West Attica

Athens, Attica, Greece

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Central Study Contacts

Irini Patsaki, PhD

CONTACT

+306942064363ipatsaki@uniwa.gr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 10, 2025

First Posted

August 20, 2025

Study Start

January 8, 2025

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

August 20, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)