Feasibility and acceptability of inspiratory muscle training in Parkinson's disease

Given the uncertainty of the global health situation over the next 18 months, we will describe face to face and telehealth approaches and use the approach according to current guidelines. We plan to recruit participants who are already attending group classes at the University of Canberra Student Led Neurological Rehabilitation Clinic. Currently (July 2020), these participants are participating in classes face-to-face and via telehealth. We propose to provide the participants the option of participating either via telehealth, or in person in the clinic whilst remaining inline with all public health recommendations. Given the degree of uncertainty of the global health situation over the next 18 months, we have outlined protocols for either face to face or telehealth to facilitate conducting this research in line with public health recommendations and patient preferences. If face-to-face consultations are allowed there will be an initial consultation with the participants whereby their maximal inspiratory pressure will be determined. This is an indirect measure of their inspiratory muscle strength and involves inhaling forcefully through a hand-held pressure metre 3 times (described in more detail below). We will also measure each participant’s grip strength as this has been found to be a useful predictor of health factors including mortality, disability and prolonged hospitalisation in other populations. At initial consultation we will also perform a quality of life questionnaire (PDQ-39), demographic survey and Borg dyspnoea scale. The aforementioned measures will be performed by an assessor blinded to the research’s outcomes. Following these measures, a different research officer will then demonstrate how the participant’s training program will work, explain how to set up their training device and the protocol to follow. We will also provide a written outline of the training schedule, and this will also function as a ‘diary’ where they can enter their daily training levels, adherence and any adverse events. In total, we anticipate the baseline measurement and protocol set-up appointment to take approximately half an hour. If restrictions allow respiratory muscle testing, Maximum Inspiratory Pressure testing will be performed with MicroRPM Respiratory Pressure Meter and testing will follow the American Thoracic Society’s guidelines for testing. This is a non-invasive procedure whereby the participant will be seated, instructed to breathe out as far as they can until they “empty their lungs”. They will then seal their mouth around the mouthpiece, either pinch their nose or use or a nose peg, and take one quick, hard and fast breath in. This will initially be shown to the participant by the assessor before performing the test themselves. The test will be repeated 2 more times, with breaks allowed in between – the participant will lead as to when they are ready to perform the next test. The best reading of 3 will be taken. Total procedure time will take less than 5 minutes. If restrictions do not allow face-to-face consultation, we propose to do initial consult via telehealth. These patients are currently participating in exercise classes through the clinic’s telehealth service, so we do not see this being a concern for participants. Instead of a direct measure of maximum inspiratory pressure, we will use the inspiratory muscle training device to determine an appropriate training load with verbal guidance from the research team. Initial questionnaires will be done over the telehealth consult, and training will continue as per training protocol. All required training devices and diaries will be delivered to participant’s home prior to commencement. After the initial consultation, participants will be left to train in their own time, recording training in a diary, with weekly check ins with the research team (via telehealth / phone call) to adjust training levels, answer questions and provide continuation of training. Participants will need to set their device to the predetermined pressure level (at 50% maximal inspiratory pressure), and do six inspiratory breaths, 5 times over - taking 15-20 minutes. Participants will perform this 5 days per week for 6 weeks. Training intensity will be discussed and adjusted weekly as necessary based on participant tolerability. Participants should find this to be of a moderate level of exertion and be able to ‘just’ complete 6th breath in each set. Intervention training will be provided to participants by a Physiotherapy student under the supervision of an experienced Physiotherapist. After 6 weeks training there will be a final appointment with participants. This will be to gather information on acceptability, gather their training diaries and do a final measure of maximal inspiratory pressure (if appointment is face to face, and test is permitted), quality of life, Borg Dyspnoea scale and grip strength (if face to face). Again, these measures will be performed by an assessor blinded to the outcomes of the study, and will take approximately half an hour per participant.