A novel treatment approach targeting respiratory muscle strength in children who aspirate.

Randomised control trial using respiratory muscle strength training (RMST). An Expiratory muscle strength training (EMST) 150 or 75 device will be given to participants to use with their parent/carer supervision. For the intervention arm, an EMST 150 or 75 device will be utilised whereby short duration, isometric contractions of the expiratory muscles generate the pressure to open the device’s release valve. During training, the device is adjusted to progressively increase the resistance through the measurement of a participant’s own Mean Expiratory Pressure (MEP) and setting the device to a percentage of that MEP for training (e.g. 75% of MEP). If children are unable to perform MEP, then the device resistance will be adjusted in accordance with their clinical ability to perform the manoeuvre. In the sham intervention (control) arm children will receive a plastic mask (spacer mask), with no resistance and perform the same manoeuvre as the RMST. Children will undergo at least one guided session for one hour provided by the researcher, either face to face or via telehealth whichever is preferred, and then complete 6 weeks of RMST comprising of 5 sets of 5 repetitions per day (25/day) for 5 days each week. Carers will be given a diary to record RMST sessions over this 6 week period. A review session will take place at Week-3 and Week-7 in the respiratory outpatient clinic or via teleheatlh, for 30 minutes, with the researcher who will record progress. Treatment adherence, adverse events, and any information from respiratory related hospital presentations or admissions will be recorded. Repeat Videofluoroscopy (VFSS), Pulmonary Function Tests (PFT) (where possible) and clinic review of both groups (RMST and control) will occur at Week-7 and another clinical respiratory review at 6 months post randomisation which will assess for adverse events and any information from respiratory related hospital presentations or admissions.