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

JRCT ID: jRCT1042240036

Registered date:29/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Aspiration Pneumonia
• Date of first enrollment: 13/08/2024
• Target sample size: 70
• Study type: Interventional
• Intervention(s): 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 pressure (PEmax) for 5 sets of 5 breaths per day (with a 1-minute rest in between sets). This is done 5 days a week. Conventional standard swallowing training is also performed at the same time. Maximal expiratory intraoral pressure (PEmax) will be measured weekly and the expiratory muscle training load will be changed accordingly.

Outcome(s)

• Primary Outcome: Percentage of patients not on alternative nutrition 3 weeks after the start of expiratory muscle training

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 60age old
• Age maximum: <= 90age old
• Gender: Both

Include 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 and give written consent to participate in this study.

Exclude 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.

Related Information

• Primary Sponsor: Ohkubo Hirotsugu