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Trial registered on ANZCTR


Trial ID
ACTRN12614000975695
Ethics application status
Approved
Date submitted
1/09/2014
Date registered
11/09/2014
Date last updated
3/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The feasibility and safety of inspiratory muscle training for patients with acute spinal cord injury
Scientific title
Inspiratory muscle training for patients with acute spinal cord injury: feasibility and safety
Secondary ID [1] 285271 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal cord injury. 292924 0
Condition category
Condition code
Physical Medicine / Rehabilitation 293209 293209 0 0
Physiotherapy
Respiratory 293210 293210 0 0
Other respiratory disorders / diseases
Injuries and Accidents 293267 293267 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 290153 0
Treatment: Devices
Intervention code [2] 290231 0
Rehabilitation
Comparator / control treatment
Not applicable.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293078 0
Feasibility of inspiratory muscle training. The feasibility of inspiratory muscle training in the early stages post-spinal cord injury will be documented by the principal investigator 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).
Timepoint [1] 293078 0
At each training session during the participant's stay, to a maximum of 4 weeks.
Primary outcome [2] 293079 0
Safety of inspiratory muscle training. The main outcome measures relating to the safety of the intervention will be measured and recorded by the primary investigator (e.g. respiratory distress and/or fatigue [increased respiratory rate, oxygen desaturation, rate of perceived exertion]). At each training session this will include measurement of respiratory rate, heart rate, percutaneous oxygen saturation, blood pressure and rate of perceived exertion. Respiratory rate will be counted by visual observation. Oxygen saturation and heart rate will be measured using a portable oximeter. Blood pressure will be measured non-invasively with an electronic sphygmomanometer. Rate of perceived exertion will be self-rated by the participant using the Borg Scale. These measurements will be recorded for the purpose of analyses just prior to every inspiratory muscle training intervention, at the completion of the inspiratory muscle training session and 5 minutes post-session. Training conditions, observations (including occurrence of any increased spasticity), remarks and adverse events will be recorded.
Additionally, on the first occasion of inspiratory muscle training, electrocardiogram monitoring will be undertaken immediately before, during and after the inspiratory muscle training to detect the occurrence of cardiac arrhythmias. This monitoring will be undertaken using an automatic external defibrillator device (AED; Medtronic). This unit has the ability to allow attachment of three electrodes (leads) to the right arm/shoulder, left arm/shoulder and left lower chest/leg and displays the electrocardiogram waveform on a small screen. It gives an auditory alarm if any shockable arrhythmia occurs and auditory prompts to change the leads to defibrillation pads/electrodes. The defibrillator-component of the device will not be attached or utilised unless required as part of the medical intervention (basic life support) in the unlikely event that a major arrhythmia occurs. If a major arrhythmia is detected at baseline before inspiratory muscle training has commenced, inspiratory muscle training will not be instituted at that time, nursing/medical staff will be informed and inspiratory muscle training only commenced once deemed safe by medical staff. In the event of a major arrhythmia occurring during inspiratory muscle training, inspiratory muscle training will be immediately ceased and appropriate medical intervention sought. The occurrence of any major arrhythmia will be recorded for purposes of the study, along with any intervention required in its management. Further inspiratory muscle training will only be commenced once deemed safe by medical staff: in this instance, electrocardiogram monitoring will be undertaken during inspiratory muscle training for that person for at least the next week or until their cardiac condition is stable (i.e. no arrhythmias).
Participants’ medical records will be reviewed to ascertain the occurrence of any respiratory complications (e.g. respiratory infection, lobar collapse, sputum retention) or escalation of respiratory support (e.g. higher level of supplemental oxygen, invasive or non-invasive mechanical ventilation) during the study period.
Timepoint [2] 293079 0
At each training session during the participant's stay, to a maximum of 4 weeks.
Secondary outcome [1] 310294 0
Efficacy data. To assess the efficacy of inspiratory muscle training, maximal inspiratory pressure, vital capacity and peak expiratory flow rate will be recorded by the primary investigator just prior to every inspiratory muscle training intervention and weekly data used for analyses. These measurements will be taken with the participant in the same position over the duration of the study period – either sitting out of bed or supine in bed with the bedhead elevated to 45 degrees or the maximum amount allowed. Maximal inspiratory pressure (from residual capacity) will be measured using the POWERbreathe KH1 device, and vital capacity and peak expiratory flow rate measured using a spirometer, with the best of at least 3 attempts recorded. Tests will be repeated until the variability is less than 5 per cent. Additionally, the participant will be asked to rate their best and worst rate of perceived exertion (Borg scale) in a 24-hour period on a weekly basis.
Timepoint [1] 310294 0
At each training session during the participant's stay, to a maximum of 4 weeks.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Raw data will be collected on a purpose-designed form and subsequently entered onto an Excel spreadsheet by one of the investigators. Data will be imported into SPSS for analysis. Analyses will be predominantly descriptive in nature.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 2946 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 8653 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 289891 0
Charities/Societies/Foundations
Name [1] 289891 0
Health Services Charitable Gifts Board, Royal Adelaide Hospital Physiotherapy Centenary Foundation
Address [1] 289891 0
Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country [1] 289891 0
Australia
Primary sponsor type
Individual
Name
Kathy Stiller
Address
Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country
Australia
Secondary sponsor category [1] 288576 0
Individual
Name [1] 288576 0
Tony McDonald
Address [1] 288576 0
Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country [1] 288576 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291614 0
Research Ethics Committe, Royal Adelaide Hospital
Ethics committee address [1] 291614 0
Level 3, Hanson Institute
IMVS Building
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Ethics committee country [1] 291614 0
Australia
Date submitted for ethics approval [1] 291614 0
Approval date [1] 291614 0
10/02/2014
Ethics approval number [1] 291614 0
HREC/13/RAH/527

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51154 0
Mr Tony McDonald
Address 51154 0
Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country 51154 0
Australia
Phone 51154 0
61 8 82225334
Fax 51154 0
61 8 82224279
Email 51154 0
tony.mcdonald@health.sa.gov.au
Contact person for public queries
Name 51155 0
Dr Kathy Stiller
Address 51155 0
Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country 51155 0
Australia
Phone 51155 0
61 8 82225334
Fax 51155 0
61 8 82224279
Email 51155 0
kathy.stiller@health.sa.gov.au
Contact person for scientific queries
Name 51156 0
Dr Kathy Stiller
Address 51156 0
Physiotherapy Department
Royal Adelaide Hospital
North Terrace
Adelaide
South Australia 5000
Country 51156 0
Australia
Phone 51156 0
61 8 82225334
Fax 51156 0
61 8 82224279
Email 51156 0
kathy.stiller@health.sa.gov.au