None listed
Conditions
Brief summary
Breathing and coughing difficulties are extremely distressing for people living with MND and therapies that improve breathing capacity and related symptoms are needed. Our research team has previously shown that breathing exercises using a hand-held device to help people take a bigger breath (lung volume recruitment) can produce important changes in lung capacity. Separately, our collaborators in the United States have found that exercises using a different hand-held device (expiratory muscle strength training) can improve expiratory muscle strength in people with MND. This research project will evaluate whether combining these two therapies together has added benefit. We will test whether five weeks of combined respiratory training is feasible and acceptable to people living with MND and their carers, and whether it improves breathing and cough strength, symptoms and quality of life in people affected by MND.
Interventions
All enrolled participants will commence a combined lung volume recruitment and expiratory muscle strength training exercise regimen (LVR and EMST), following a 5-week no-intervention lead-in period.
Intervention description: LVR uses a self-inflating bag (similar to a resuscitation bag) with a mouthpiece or mask to deliver consecutive insufflations (i.e., large “puffs” of air), to “stack” a larger volume of air than can be inspired spontaneously.
EMST uses a spring-loaded pressure threshold de
All enrolled participants will commence a combined lung volume recruitment and expiratory muscle strength training exercise regimen (LVR and EMST), following a 5-week no-intervention lead-in period. Intervention description: LVR uses a self-inflating bag (similar to a resuscitation bag) with a mouthpiece or mask to deliver consecutive insufflations (i.e., large “puffs” of air), to “stack” a larger volume of air than can be inspired spontaneously. EMST uses a spring-loaded pressure threshold device to provide resistance as one breaths out. This study combines these two devices, so that a person "stacks" a volume of air in using the LVR bag, and then exhales through the resistive training device. Intervention dose: Participants will be instructed to complete 5 sets of 5 repetitions of combined LVR+EMST into a single device on 5 days per week for 5 weeks (total of 25 intervention sessions over a 5-week period). One repetition consists of an individually prescribed number of compressions via the LVR bag to reach the maximal tolerated inflation capacity, followed by a forceful expiration through the EMST device, set at 50% of the participant’s maximal expiratory pressure (MEP). Exercises are usually performed seated (chair or wheelchair), and take approximately 20 minutes to complete. An experienced health care professional (e.g. physiotherapist with experience in the provision of respiratory care) will prescribe the therapy and ensure participants are trained in its appropriate use. This initial training will be performed in the participant's home, face-to-face. Subsequent sessions will be conducted by the participant themselves, with the assistance of their caregiver (if required), in their home environment. Training technique will be reviewed by a member of the research team via telehealth weekly for the duration of the study. Adherence to the intervention will be assessed via a participant diary, as well as via a LVR counter attached to the LVR kit.
Sponsors
Institute for Breathing and Sleep (IBAS)
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
A diagnosis of MND/ALS, according to the revised El Escorial criteria (possible, probable laboratory supported, probable, or definite). Forced vital capacity (FVC) greater than or equal to 50% predicted normal reference values. Naïve to lung volume recruitment (LVR) and expiratory muscle strength training (EMST). Provided a signed and dated informed consent form (or witnessed signed form if unable to write),
Exclusion criteria
Medical instability (e.g., acute medical issues/hospitalisation). History of stroke, head and neck cancer or other concomitant disorder that might contribute to dysphagia or respiratory impairment. Diagnosis of frontotemporal dementia or advanced cognitive impairment. Use of prescription mechanical insufflation-exsufflation or non-invasive ventilation devices. Tracheostomy / use of invasive mechanical ventilation. Enrolment in another research investigation that might impact cough or respiratory function. Contraindications for respiratory training (i.e., history of spontaneous pneumothorax, severe chronic obstructive pulmonary disease). Unable to physically perform or can’t tolerate LVR. Home visit safety risk. Unable to provide informed consent. Limited English proficiency. Resides more than 2 hours travel time from Austin Health.
Outcome results
None listed