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
Scientific title
Inspire Beyond ICU” - Effect of inspiratory muscle training on quality of life in ICU patients requiring mechanical ventilation: a multicentre randomised trial
Secondary ID [1] 312029 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12624000573550 is a precursor study to establish usual baseline care in each centre participating in the RCT (current study).

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 333634 0
Inspiratory Muscle Training 333586 0
Respiratory Muscle Weakness 333584 0
Prolonged Mechanical Ventilation 333585 0
Post ICU Syndrome 333925 0
Condition category
Condition code
Respiratory 330265 330265 0 0
Other respiratory disorders / diseases
Physical Medicine / Rehabilitation 330266 330266 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 328435 0
Treatment: Devices
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).
Control group
Active

Outcomes
Primary outcome [1] 338017 0
Satisfaction with life and personal enjoyment. This will be assessed as a composite outcome.
Timepoint [1] 338017 0
6 weeks (Primary endpoint), baseline, 3 months, 6 months and 12 months from enrollment.
Secondary outcome [1] 442257 0
Pulmonary Function
Timepoint [1] 442257 0
6 weeks, 3 months, 6 months & 12 months from enrollment.
Secondary outcome [2] 434131 0
Survival
Timepoint [2] 434131 0
6 & 12 months from enrollment.
Secondary outcome [3] 442872 0
Survival
Timepoint [3] 442872 0
6 & 12 months from enrollment.
Secondary outcome [4] 442873 0
Neurological disability
Timepoint [4] 442873 0
6 & 12 months from enrollment.
Secondary outcome [5] 442254 0
Cognition
Timepoint [5] 442254 0
Baseline, 6 weeks, 3 months, 6 months & 12 months from enrollment,
Secondary outcome [6] 442255 0
Physical Function
Timepoint [6] 442255 0
Baseline, 6 weeks, 3 months, 6 months & 12 months from enrollment.
Secondary outcome [7] 442252 0
Mental Health
Timepoint [7] 442252 0
Baseline, 6 weeks, 3 months, 6 months & 12 months from enrollment.
Secondary outcome [8] 442878 0
Physical Function
Timepoint [8] 442878 0
Baseline, 6 weeks, 3 months, 6 months, and 12 months from enrollment.
Secondary outcome [9] 442258 0
Consumer Consultation
Timepoint [9] 442258 0
6 weeks, 6 months and 12 months from enrollment.
Secondary outcome [10] 442880 0
Pulmonary Function
Timepoint [10] 442880 0
6 weeks, 3months, 6 months and 12 months from enrollment.
Secondary outcome [11] 442253 0
Pain
Timepoint [11] 442253 0
Baseline, 6 weeks, 3 months, 6 months & 12 months from enrollment,
Secondary outcome [12] 442879 0
Nerve function
Timepoint [12] 442879 0
MIP: Baseline and up until 6 weeks from enrollment. MIT: up until 6 weeks from enrollment.
Secondary outcome [13] 442256 0
Muscle function
Timepoint [13] 442256 0
MIP: Baseline and up until 6 weeks from enrollment MIT: up until 6 weeks from enrollment.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be centralised and administered through the RedCAP database system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2026
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,TAS,WA,VIC
Recruitment outside Australia
Country [1] 26756 0
New Zealand
State/province [1] 26756 0

Funding & Sponsors
Funding source category [1] 316328 0
Hospital
Name [1] 316328 0
Canberra Hospital
Country [1] 316328 0
Australia
Funding source category [2] 316321 0
Hospital
Name [2] 316321 0
Mater Misericordiae Ltd
Country [2] 316321 0
Australia
Funding source category [3] 316329 0
University
Name [3] 316329 0
University of Canberra
Country [3] 316329 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
Country
Australia
Secondary sponsor category [1] 320365 0
None
Name [1] 320365 0
Address [1] 320365 0
Country [1] 320365 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315134 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 315134 0
Ethics committee country [1] 315134 0
Australia
Date submitted for ethics approval [1] 315134 0
10/04/2024
Approval date [1] 315134 0
04/12/2024
Ethics approval number [1] 315134 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133774 0
Prof Bernie Bissett
Address 133774 0
Office 8, level 2, University of Canberra Hospital, 20 Guraguma St, Bruce ACT 2617
Country 133774 0
Australia
Phone 133774 0
+61 404319234
Fax 133774 0
Email 133774 0
[email protected]
Contact person for public queries
Name 133775 0
Bernie Bissett
Address 133775 0
Office 8, level 2, University of Canberra Hospital, 20 Guraguma St, Bruce ACT 2617
Country 133775 0
Australia
Phone 133775 0
+61 404319234
Fax 133775 0
Email 133775 0
[email protected]
Contact person for scientific queries
Name 133776 0
Bernie Bissett
Address 133776 0
Office 8, level 2, University of Canberra Hospital, 20 Guraguma St, Bruce ACT 2617
Country 133776 0
Australia
Phone 133776 0
+61 404319234
Fax 133776 0
Email 133776 0
[email protected]

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.