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Effect of Inspiratory Muscle Training on Symptom Severity and Quality of Life in Non-Erosive Reflux Disease

6. maj 2026 opdateret af: Ridvan Aktan, Izmir University of Economics

Effect of Inspiratory Muscle Training on Clinical Symptom Severity and Quality of Life in Patients With Non-erosive Reflux Disease: A Randomized Controlled Trial

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

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Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Tyrkiet (Türkiye)
    • Balçova
      • Izmir, Balçova, Tyrkiet (Türkiye), 35330
        • Izmir University of Economics
        • Kontakt:
        • Underforsker:
          • Nilay Danış, Assoc Prof.
        • Underforsker:
          • Caner Bektaş, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • A clinical diagnosis of NERD,
  • No erosive lesions on endoscopy,
  • Presence of reflux symptoms for at least 3 months.

Exclusion Criteria:

  • Using proton pump inhibitors (PPIs)
  • With known gastroduodenal ulcers
  • Diagnosed with erosive esophagitis
  • With hiatal hernia
  • With a history of gastrointestinal malignancy
  • With infectious or inflammatory gastrointestinal diseases
  • With malabsorption syndrome or gastrointestinal obstruction
  • With a history of major gastrointestinal surgery (including anti-reflux, gastric, or duodenal surgery)
  • With systemic sclerosis or other systemic connective tissue diseases
  • With severe cardiovascular, pulmonary, renal, or hepatic disease
  • With chronic respiratory diseases such as asthma or COPD
  • Having had an acute respiratory tract infection within the past 4 weeks
  • With neuromuscular diseases
  • With active tuberculosis
  • Pregnancy

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Study Group
Patients who will perform inspiratory muscle training (IMT) with %60 loading
Enhed: Inspiratory Muscle Training (IMT)
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.
Sham-komparator: Sham Group
Patients who will perform Sham IMT
Enhed: Sham IMT
IMT-protokollen vil bestå af hjemmebaseret daglig træning - to cyklusser af 30 vejrtrækninger med 1 min pause mellem sæt, to gange dagligt i 8 uger ved brug af en IMT Threshold-enhed (Threshold IMT Philips® Respironics, Inc.). Intensiteten af ​​træningen vil blive indstillet til den laveste intensitet af IMT Threshold-enheden.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Symptom Severity
Tidsramme: 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.
4 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Inspiratory Muscle Strength
Tidsramme: 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).
4 weeks
Gastroesophageal Reflux Disease-Related Quality of Life
Tidsramme: 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.
4 weeks
Change in Diagnostic Symptom Score
Tidsramme: 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.
4 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Izmir University of Economics

Efterforskere

  • Ledende efterforsker: Rıdvan Aktan, Assoc Prof., Izmir University of Economics

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. juni 2026

Primær færdiggørelse (Anslået)

15. december 2026

Studieafslutning (Anslået)

15. maj 2027

Datoer for studieregistrering

Først indsendt

6. maj 2026

Først indsendt, der opfyldte QC-kriterier

6. maj 2026

Først opslået (Faktiske)

13. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • E-97429853-050.04- 124388

Plan for individuelle deltagerdata (IPD)

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INGEN

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Kliniske forsøg med Ikke-erosiv reflukssygdom (NERD)

Kliniske forsøg med Sham IMT

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