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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12625000027415
Ethics application status
Approved
Date submitted
26/11/2024
Date registered
15/01/2025
Date last updated
15/01/2025
Date data sharing statement initially provided
15/01/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Inspire Beyond ICU: Inspiratory muscle training for Intensive Care patients requiring prolonged mechanical ventilation
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Scientific title
Inspire Beyond ICU” - Effect of inspiratory muscle training on quality of life in ICU patients requiring mechanical ventilation: a multicentre randomised trial
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Secondary ID [1]
312029
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
ACTRN12624000573550 is a precursor study to establish usual baseline care in each centre participating in the RCT (current study).
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Health condition
Health condition(s) or problem(s) studied:
Critical Illness
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Inspiratory Muscle Training
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Respiratory Muscle Weakness
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Prolonged Mechanical Ventilation
333585
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Post ICU Syndrome
333925
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Condition category
Condition code
Respiratory
330265
330265
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0
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Other respiratory disorders / diseases
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Physical Medicine / Rehabilitation
330266
330266
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0
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Physiotherapy
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Training will commence as soon as patients meet eligibility criteria (including being stable, awake and alert and consenting to participate in training). This will be either while ventilator-dependent, or within 7 days of liberation from the ventilator (in the Intensive Care or on the wards). Regardless of when the patient commences training, they will continue for 6 weeks total training. The 6 weeks could be entirely within the Intensive Care Unit (ICU), or in the acute hospital wards, or rehabilitation settings, or home. The intervention is as follows:
Within ICU: 5 days per week (Monday - Friday) high-intensity electronic Inspiratory Muscle Training (IMT) using the POWERbreathe KH2 at 30 breaths (5 sets of 6 breaths up to total lung capacity); minimum resistance 50% of Maximal Inspiratory Pressure (MIP).
Post ICU discharge: 5 days per week (Monday - Friday) high-intensity IMT coached and supervised by a physiotherapist or allied health assistant using a single-patient-use spring-loaded IMT device (POWERbreathe Medic Plus), 5 sets of 6 breaths per day for 6 weeks from study commencement. The clinician will increase resistance until the patient is just able to open the poppet on the 6th breath of each set.
Post-acute hospital discharge: Patients discharged from the hospital < 6 weeks post enrolment (either to home or inpatient rehabilitation) will continue IMT 5 days per week (Monday - Friday) using the POWERbreathe MedicPlus. A subgroup will use a recently developed “smart adaptor” that enables ongoing data collection through an application on the patient’s phone or device. Patients will self-progress resistance so that they are just able to open the poppet on the 6th breath of each set. Weekly follow-up via phone will maximise treatment adherence. Treatment adherence will be recorded via both training diary and/or the “smart adaptor” application.
Regardless of which device is used (POWERbreathe KH2 or POWERbreathe MedicPlus), the procedure for patients is the same. Patients will inhale against a specified resistance (as programmed by the treating physiotherapist). They will complete 5 sets of 6 breaths against this resistance, with rests in between as required (including returning to the ventilator if commenced while ventilator-dependent). The patient will breathe into the device via a mouth piece, or if the patient is still ventilator-dependent, or has a tracheostomy in situ, the training device will be connected directly to their artificial airway with a connector as required. Total training time per session is typically less than 10 minutes. Treatment in ICU will be supervised by a physiotherapist or assistant.
Training can continue with the spring-loaded MedicPlus training device regardless of location, as this single-patient device stays with the patient. If the patient has returned home, then training can continue independently with weekly follow up via phone via a physiotherapist or assistant, while recording of training activity will occur via the TrackActive Pro App or the smart adaptor app, or with paper-based recording depending on patient’s preference.
Smart adaptor training app: A subset of patients will be offered the opportunity to combine the MedicPlus device with a smart adaptor which interfaces with an app on their personal device (e.g. phone or ipad). This app will provide detailed training information and feedback to patients and the research team. This option will only be offered to sites which have funding for smart adaptors (Canberra Hospital, Sunshine Coast University Hospital). The maximum number of participants offered this option is limited by funding of the smart adaptor (as of December 2024, limited to 37). Should other funding options be successful, we may increase sites to include Ipswich Hospital, with a likely total target enrolment of 50 patients using the smart adaptor.
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Intervention code [1]
328435
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Treatment: Devices
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Comparator / control treatment
Usual physiotherapy respiratory care for each facility. Usual care includes treatments such as breathing exercises (without a resistance device), mobilisation, strength and range of motion exercises for peripheral muscles, functional activity practice (e.g. sit to stand) and respiratory treatments targeting lung clearance (e.g. percussion, vibrations, postural drainage, hyperinflation, suction etc). Usual physiotherapy care will be captured in a pre-study audit (commencing October 2024).
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Control group
Active
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Outcomes
Primary outcome [1]
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Satisfaction with life and personal enjoyment. This will be assessed as a composite outcome.
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Assessment method [1]
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EQ5D-5L
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Timepoint [1]
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6 weeks (Primary endpoint), baseline, 3 months, 6 months and 12 months from enrollment.
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Secondary outcome [1]
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Pulmonary Function
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Assessment method [1]
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Breathlessness via Modified BORG following 30 sec STS
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Timepoint [1]
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6 weeks, 3 months, 6 months & 12 months from enrollment.
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Secondary outcome [2]
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Survival
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Assessment method [2]
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All-cause mortality
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Timepoint [2]
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6 & 12 months from enrollment.
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Secondary outcome [3]
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Survival
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Assessment method [3]
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Days Alive and Out of Hospital. This will be determined from medical records (if deceased or drop-out from study) or patient self-report.
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Timepoint [3]
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6 & 12 months from enrollment.
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Secondary outcome [4]
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Neurological disability
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Assessment method [4]
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Modified Rankin Scale
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Timepoint [4]
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6 & 12 months from enrollment.
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Secondary outcome [5]
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Cognition
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Assessment method [5]
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WHODAS 2.0* Items S3, S6, S12
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Timepoint [5]
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Baseline, 6 weeks, 3 months, 6 months & 12 months from enrollment,
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Secondary outcome [6]
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Physical Function
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Assessment method [6]
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Sit to stand in 30 seconds (30 sec STS)
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Timepoint [6]
442255
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Baseline, 6 weeks, 3 months, 6 months & 12 months from enrollment.
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Secondary outcome [7]
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Mental Health
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Assessment method [7]
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World Health Organisation Disability Assessment Schedule 2.0 (WHODAS 2.0) Short Form (12-item) * Items S4, S5, S10, S11, S12
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Timepoint [7]
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Baseline, 6 weeks, 3 months, 6 months & 12 months from enrollment.
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Secondary outcome [8]
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Physical Function
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Assessment method [8]
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WHODAS 2.0 - Items s1, s2, s7, s8, s9, s12.
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Timepoint [8]
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Baseline, 6 weeks, 3 months, 6 months, and 12 months from enrollment.
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Secondary outcome [9]
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Consumer Consultation
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Assessment method [9]
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Consumer perspectives of intervention used. This will be determined by a phone interview with a member of the research team (or research assistant trained in the techniques). The phone interview is anticipated to take a total of 30 minutes or less and will not be audio recorded.
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Timepoint [9]
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6 weeks, 6 months and 12 months from enrollment.
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Secondary outcome [10]
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Pulmonary Function
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Assessment method [10]
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Dyspnea via Dyspnea-12
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Timepoint [10]
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6 weeks, 3months, 6 months and 12 months from enrollment.
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Secondary outcome [11]
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Pain
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Assessment method [11]
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EQ-5D pain question
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Timepoint [11]
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Baseline, 6 weeks, 3 months, 6 months & 12 months from enrollment,
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Secondary outcome [12]
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Nerve function
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Assessment method [12]
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Maximal inspiratory pressure (MIP) and IMT training load (intervention group only)
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Timepoint [12]
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MIP: Baseline and up until 6 weeks from enrollment. MIT: up until 6 weeks from enrollment.
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Secondary outcome [13]
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Muscle function
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Assessment method [13]
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Maximal inspiratory pressure (MIP) and IMT Training Load (intervention group only).
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Timepoint [13]
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MIP: Baseline and up until 6 weeks from enrollment MIT: up until 6 weeks from enrollment.
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Eligibility
Key inclusion criteria
1. Alert and co-operative (Patient following commands and correctly responds to greater than or equal to 4 de Jonghe 5 Question Assessment),
2. Invasively mechanically ventilated 5 days or longer
3. Patient is likely to remain in acute hospital for at least one week from time of study enrolment.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Ceased invasive mechanical ventilation more than seven-days ago
2. New or existing neurological conditions that are likely to affect breathing capacity
3. Significant pain from chest trauma or surgery affecting breathing capacity
4. Rib fractures with flail segment on removal of positive pressure.
5. Undrained pneumothorax
6. Clinician opinion patient unsuitable
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be centralised and administered through the RedCAP database system.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number sequence.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/07/2025
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Actual
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Date of last participant enrolment
Anticipated
31/12/2026
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Actual
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Date of last data collection
Anticipated
31/12/2027
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Actual
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS,WA,VIC
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Recruitment outside Australia
Country [1]
26756
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New Zealand
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State/province [1]
26756
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Funding & Sponsors
Funding source category [1]
316328
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Hospital
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Name [1]
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Canberra Hospital
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Address [1]
316328
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Country [1]
316328
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Australia
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Funding source category [2]
316321
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Hospital
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Name [2]
316321
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Mater Misericordiae Ltd
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Address [2]
316321
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Country [2]
316321
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Australia
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Funding source category [3]
316329
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University
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Name [3]
316329
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University of Canberra
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Address [3]
316329
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Country [3]
316329
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Australia
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Primary sponsor type
University
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Name
University of Canberra
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
320365
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Country [1]
320365
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315134
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ACT Health Human Research Ethics Committee
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Ethics committee address [1]
315134
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https://health.act.gov.au/act-health-system/research-data-and-publications/research/research-ethics-and-governance
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Ethics committee country [1]
315134
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Australia
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Date submitted for ethics approval [1]
315134
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10/04/2024
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Approval date [1]
315134
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04/12/2024
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Ethics approval number [1]
315134
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Summary
Brief summary
The sickest patients in the intensive care unit (ICU) receive prolonged, invasive mechanical support for their breathing, which may be lifesaving. But after this, it is common for the breathing muscles to be weak, which makes it difficult to get back to normal breathing, with an increased risk of death or poor recovery. We have found that 2 weeks of breathing muscle training, started in the ICU, is safe, improves breathing muscle strength, and may improve quality of life after ICU. This study tests whether 6 weeks of training improves quality of life after ICU in a larger group of up to 300 patients. We do not know whether the longer period of training will result in significantly better outcomes for patients, and the results of this study will help physiotherapists know whether this is a useful approach for future ICU survivors.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Bernie Bissett
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Address
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Office 8, level 2, University of Canberra Hospital, 20 Guraguma St, Bruce ACT 2617
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Country
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Australia
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Phone
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+61 404319234
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Bernie Bissett
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Address
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Office 8, level 2, University of Canberra Hospital, 20 Guraguma St, Bruce ACT 2617
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Country
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Australia
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Phone
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+61 404319234
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Bernie Bissett
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Address
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Office 8, level 2, University of Canberra Hospital, 20 Guraguma St, Bruce ACT 2617
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Country
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Australia
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Phone
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+61 404319234
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Fax
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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