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A study to confirm whether expiratory muscle training is useful for improving swallowing function in patients with aspiration pneumonia

A randomized controlled study on the effect of expiratory muscle training on improving swallowing functions in patients with aspiration pneumonia - ETAP trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1042240036
Enrollment
70
Registered
2024-05-29
Start date
2025-05-19
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aspiration Pneumonia Pneumonia

Interventions

Starting the day after random assignment (excluding holidays), participants will perform expiratory muscle training using Power Breathe EX Medic at a load of 50-70% of maximum expiratory intraoral pre
Breathing Exercises
inspiratory muscle training

Sponsors

Ohkubo Hirotsugu
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients admitted for pneumonia who are considered to have aspiration pneumonia (2) Patients with pneumonia severity ADROP score of 0 to 3 (3) Patients with a repetitive salivary swallow test of 5 times or less/30 seconds (4) Patients whose maximum expiratory intraoral pressure (PEmax) can be measured with the IOP-01 intraoral pressure meter (5) Patients who understand participation in this study and from whom written consent is obtained, either from the patient themselves or from a legal representative.

Exclusion criteria

Exclusion criteria: (1) Asthmatics with frequent exacerbations (2) Patients with signs or symptoms of heart failure or with a history of worsening of signs or symptoms of heart failure after inspiratory muscle training (3) Patients with a history of spontaneous pneumothorax (4) Patients with ear damage such as ruptured eardrums (5) Patients with a history or high likelihood of costochondritis dissecans. (6) Patients with systolic blood pressure greater than 180 mmHg (7) Patients for whom nasal cannula is inadequate to maintain blood oxygenation and who require an oxygen mask (8) Patients on gastrostomy or nasogastric tube feeding, or central venous port feeding (9) Other patients deemed inappropriate as research subjects by the principal/assistant investigator.

Design outcomes

Primary

MeasureTime frame
Percentage of patients not on alternative nutrition 3 weeks after the start of expiratory muscle training

Secondary

MeasureTime frame
Change in maximum expiratory intraoral pressure (PEmax) using an intraoral manometer Change in the results of repeated salivary swallow test Weekly changes in the level of feeding and swallowing status from the start of expiratory muscle training to 3 weeks after the start of expiratory muscle training Recurrence of aspiration pneumonia during hospitalization Confirmation of survival Number of insurance points for medical care during hospitalization

Contacts

Public ContactNakano Akiko

Nagoya City University Midori Municipal Hospital

aki_na1114@yahoo.co.jp+81-52-892-1331

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026