Impact of Inspiratory Muscle Training in Individuals with Gastroesophageal Reflux Disease: A Randomized Controlled Trial Protocol.
Stylianos Syropoulos, Maria Moutzouri, Eirini Grammatopoulou...
https://pubmed.ncbi.nlm.nih.gov/41874149Actively Recruiting
Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID07131397
The Effect of Inspiratory Muscle Training on Inspiratory Strength in People With Gastroesophageal Reflux Disease
Led by University of West Attica · Updated on 2025-08-20
30
Participants Needed
1
Research Sites
21 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are investigating the effect of inspiratory muscle training (IMT) on inspiratory strength and symptoms in people with gastroesophageal reflux disease (GERD). This randomized controlled trial compares an IMT group with a sham IMT group to assess impacts on maximal inspiratory pressure, dynamic inspiratory pressure, GERD symptoms, and quality of life. The study aims to address diaphragm dysfunction related to GERD and improve holistic disease management. Participants will be randomly assigned to one of two groups: the experimental group receives IMT using a tapered flow resistive loading device starting at 40% of their maximum inspiratory pressure, increasing weekly by 10%, performing 36 sessions over 3 months with 3 sessions weekly, each session having 1 set of 30 breaths. The control group receives sham IMT with a constant resistance load of 7 cmH2O, also for 36 sessions over 3 months. Measurements occur before treatment, immediately after 3 months, and 6 months post-treatment. During the study, participants will undergo assessments of maximal inspiratory pressure using a digital manometer, maximum dynamic inspiratory pressure with a tapered flow resistance device, and complete questionnaires measuring GERD symptom frequency and quality of life. These evaluations take place at baseline, after the 3-month program, and again 6 months after program completion. The trial monitors changes over time to evaluate the lasting effects of the IMT program on respiratory strength and GERD impact.
CONDITIONS
Brief Title
The Effect of Inspiratory Muscle Training in People With Gastroesophageal Reflux Disease
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years
- Diagnosed with gastroesophageal reflux disease or scored more than 8 on the Gastroesophageal Reflux Disease Questionnaire
You will not qualify if you...
- Having systemic connective tissue diseases
- Having mental disorders
- History of stomach or duodenal surgery
- History of tuberculosis
- Currently pregnant
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Implementation
Duration - 12 weeks
Participants undergo inspiratory muscle training using a device with either increasing resistance or a constant sham load, performing 3 sessions per week for 12 weeks (36 sessions total).
3 sessions per week (in-person or supervised)
Follow-up
Duration - 6 months
Participants are monitored for outcomes including inspiratory strength, reflux symptoms, and quality of life for 6 months after completing the training program.
3 assessment visits at baseline, 3 months, and 9 months
Trial Site Locations
Total: 1 location
1
University of West Attica
Athens, Attica, Greece
Actively Recruiting
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Research Team
I
Irini Patsaki, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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