Izmir University of Economics
Izmir, Balçova, 35330, Turkey (Türkiye)
Location contact
Caner Bektaş, MD
SUB_INVESTIGATOR
Nilay Danış, Assoc Prof.
SUB_INVESTIGATOR
Rıdvan Aktan, Assoc Prof.
CONTACT
NCT Number: NCT07584096
The goal of this clinical trial is to learn if inspiratory muscle training (IMT) works to treat on clinical symptom severity and quality of life in patients with Non-erosive reflux disease (NERD). The main questions it aims to answer are:
Does drug IMT lower the clinical symptom severity ? Does drug IMT improve quality of life? Researchers will compare high intensity IMT to a sham-IMT (a IMT device with no resistance) to see if IMT lower the clinical symptom severity and improve improve quality of life.
Participants will perform the following protocol:
The IMT protocol will consist of home-based high-intensity training using a Threshold IMT device: two sets of 30 breaths with a 1-minute rest, twice daily for 4 weeks. The study group will train at 60% of baseline maximum inspiratory pressure (MIP), with weekly adjustments based on modified Borg scores (4-6), while the control group will perform sham IMT without resistance.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Izmir, Balçova, 35330, Turkey (Türkiye)
Caner Bektaş, MD
SUB_INVESTIGATOR
Nilay Danış, Assoc Prof.
SUB_INVESTIGATOR
Rıdvan Aktan, Assoc Prof.
CONTACT
The IMT protocol consisted of home-based high-intensity daily training - two cycles of 30 breaths with a 1-minute rest between sets, twice a day for 4 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The IMT was performed twice a day, 7 days/week, for 4 weeks. The study group performed IMT at 60% of their baseline MIP and was adjusted weekly based on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the session, while the control group performed a sham-IMT without applied resistance. Patients are evaluated before the inspiratory muscle training and after 4 weeks of training.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The IMT protocol will consist of home-based high-intensity daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training will be set to 60% of each patient's maximal inspiratory pressure, measured and adjusted weekly based on the modified Borg scale from 4 to 6 regarding respiratory effort performed during the session.
The IMT protocol will consist of home-based daily training - two cycles of 30 breaths with a 1-min rest between sets, twice a day for 8 weeks using an IMT Threshold device (Threshold IMT Philips® Respironics, Inc). The intensity of the training will be set to the lowest intensity of the IMT Threshold device.
Time frame: 4 weeks
The Reflux Disease Questionnaire (RDQ) will be used to measure the severity of clinical symptoms. The RDQ is a 12-item self-report scale that assesses the frequency and severity of upper gastrointestinal symptoms over the past week. Each item is rated on a Likert scale from 0 to 5, and the total score is calculated as the average of the relevant items. A higher score indicates more severe symptoms.
Time frame: 4 weeks
The Inspiratory muscle strength was evaluated by maximum inspiratory pressure which was assessed with a digital mouth pressure meter device (MicroRPM, Micro Medical Ltd., Rochester, Kent, United Kingdom), and recorded in cmH2O (centimeter-water).
Time frame: 4 weeks
The Gastroesophageal Reflux Disease Quality of Life Questionnaire (GERD-QOL) will be used. The questionnaire will be evaluated based on the total score, with a higher score indicating poorer quality of life.
Time frame: 4 weeks
The Gastroesophageal Reflux Disease Questionnaire (GERD-Q) will be used to assess changes in diagnostic symptom scores. A high score indicates severe symptoms.
Contact information is provided by the study sponsor or research team.
Nilay Danış, Assoc Prof.
CONTACT
Rıdvan Aktan, Assoc Prof.
CONTACT
Izmir University of Economics
Other
Effect of Inspiratory Muscle Training on Clinical Symptom Severity and Quality of Life in Patients With Non-erosive Reflux Disease: A Randomized Controlled Trial
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