None listed
Conditions
Brief summary
This study investigates the feasibility and safety of inspiratory muscle training for patients with early spinal cord injury. Patients with spinal cord injury are at high risk of respiratory complications. Inspiratory muscle training is a technique that can be used to improve the respiratory function of patients with spinal cord injury but, to date, research published about its feasibility, safety and effectiveness has only included patients who are some weeks or month post-injury. The purpose of this interventional study is to investigate the feasibility and safety of inspiratory muscle training for patients with acute spinal cord injury. The specific aims are to document, in patients with acute spinal cord injury: the feasibility of inspiratory muscle training by recording the number of physiotherapy sessions where the criteria to participate in inspiratory muscle training are met and the number of physiotherapy sessions where the criteria to participate in inspiratory muscle training are not met (and reasons why); the safety of inspiratory muscle training by recording parameters such as haemodynamic stability, oxygenation, breathlessness and respiratory complications; the effect of inspiratory muscle training on lung function parameters such as inspiratory strength and lung volumes.
Interventions
The participants will receive inspiratory muscle training with a POWERbreathe KH1 inspiratory muscle trainer. The training will be carried out with the participant positioned seated out of bed or supine in bed with the backrest elevated to 45 degrees (or as high as possible if not medically cleared to sit to 45 degrees) and wearing a nose-clip. Instructions and encouragement will be provided during the inspiratory muscle training. After an initial 2-3 day period where the inspiratory muscle trai
The participants will receive inspiratory muscle training with a POWERbreathe KH1 inspiratory muscle trainer. The training will be carried out with the participant positioned seated out of bed or supine in bed with the backrest elevated to 45 degrees (or as high as possible if not medically cleared to sit to 45 degrees) and wearing a nose-clip. Instructions and encouragement will be provided during the inspiratory muscle training. After an initial 2-3 day period where the inspiratory muscle trainer will be used with little or no load to allow the participant to get accustomed to using the device, inspiratory muscle training will commence at a load of 50 per cent of the participant’s maximum inspiratory pressure, with the aim of producing a rate of perceived exertion of between 6 and 8 using the modified Borg scale (where 0 = nothing at all and 10 = very, very severe [maximal] breathlessness). Each training session will involve 3-6 sets of 6 breaths, depending on rate of perceived exertion and/or response to inspiratory muscle training. Rests will be allowed between sets as the participant desires. Including rests, training should take less than 10 minutes per day. Once the participant’s rate of perceived exertion during an inspiratory muscle training session is less than 6 and/or the participant is able to complete the entire inspiratory muscle training session, the training pressure will be increased in the order of 10 per cent per week to a maximum of 90 per cent of maximal inspiratory pressure, according to the participant’s tolerance. Frequency of training will be 4-6 times per week, with 1-2 days rest per week to avoid staleness, fatigue and muscle injury and also for the practical reason of coinciding with our routine weekday physiotherapy service. If symptoms of respiratory fatigue develop, a rest period of up to 3 days will be provided until symptoms subside, at which time inspiratory muscle training will recommence at 50 per cent of maximal inspiratory pressure and progressed according to tolerance. The data collection period will continue for the duration of each participant’s stay at the Royal Adelaide Hospital, to a maximum of 4 weeks.
Sponsors
Kathy Stiller
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Admitted to the Spinal Injuries Unit or Intensive Care Unit of the Royal Adelaide Hospital and aged at least 18 years, an acute complete cervical or thoracic spinal cord injury (i.e. lesion level between C4 and T11), vital capacity less than predicted normal value, stable medical condition including not intubated, spontaneously breathing on room air or with nasal speculae for a minimum of 2 days.
Exclusion criteria
Refuse consent, symptomatic infection (respiratory or urinary) characterised by fever and raised white cell count, spontaneously breathing on room air or with nasal speculae for more than 7 days, severe conditions or trauma that would make inspiratory muscle training impossible, pregnancy, unable to communicate effectively and easily in English (e.g. insufficient understanding of English, cognitive impairment, psychiatric condition).
Outcome results
None listed