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Trial registered on ANZCTR


Registration number
ACTRN12610001089022
Ethics application status
Approved
Date submitted
8/12/2010
Date registered
13/12/2010
Date last updated
3/12/2020
Date data sharing statement initially provided
3/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Inspiratory Muscle Training on the Residual Respiratory Muscle Weakness and the Quality of Life of Ventilated Patients
Scientific title
In patients requiring mechanical ventilation for 7 days or longer, is inspiratory muscle training superior to standard physiotherapy in reducing the degree of residual inspiratory muscle weakness or enhancing quality of life measures?
Secondary ID [1] 253255 0
ACT Health Human Research Ethics Committee: ETH 10.10.370
Secondary ID [2] 253256 0
University of Queensland Human Research Ethics Committee: 2010001488
Universal Trial Number (UTN)
U1111-1118-4554
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inspiratory muscle weakness associated with long-term (> 7 days) ventilator dependence 258784 0
Condition category
Condition code
Respiratory 258924 258924 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Inspiratory muscle training using a threshold resistive muscle trainer, performing 5 sets of 6 breaths at an intensity of RPE 5-6 on weekdays. Patients studied while ventilator-dependent will continue to train until weaned. Patients studied post ventilatory weaning will train for 2 weeks on weekdays only. All IMT sessions will be supervised by a physiotherapist.
Intervention code [1] 257723 0
Treatment: Devices
Comparator / control treatment
Usual physiotherapy treatment (deep breathing exercises)
Control group
Active

Outcomes
Primary outcome [1] 259789 0
Fatigue resistance index, calculated by comparing maximum inspiratory pressure pre and post a 2 minute period of resisted breathing
Timepoint [1] 259789 0
Day of weaning from mechanical ventilation
1 week later for group training whilst ventilated
2 weeks later for group training post ventilatory weaning
Primary outcome [2] 259790 0
Health related quality of life, measured using SF-36v2 and EQ-5D tools (self-reported)
Timepoint [2] 259790 0
Day of weaning from mechanical ventilation
1 week later for group training whilst ventilated
2 weeks later for group training post ventilatory weaning
Primary outcome [3] 259791 0
Maximum inspiratory pressure (MIP) measured via a portable MicroRPM Respiratory Pressure meter
Timepoint [3] 259791 0
Day of weaning from mechanical ventilation
1 week later for group training whilst ventilated
2 weeks later for group training post ventilatory weaning
Secondary outcome [1] 268572 0
Duration of ventilation
Timepoint [1] 268572 0
Day of successful weaning (24 hours ventilator-free)
Secondary outcome [2] 268573 0
Length of ICU stay
Timepoint [2] 268573 0
Day of discharge from ICU
Secondary outcome [3] 268574 0
Rate of reintubation (i.e. % reintubated within 48 hours of extubation)
Timepoint [3] 268574 0
On study completion
Secondary outcome [4] 268576 0
Cortisol, creatinine and urea measurements via 24 hour urine sampling
Timepoint [4] 268576 0
On enrolment and 7 days later for those training whilst ventilated
Secondary outcome [5] 268577 0
Dyspnea - at rest and during training measured via modified borg scale (patient reprted)
Timepoint [5] 268577 0
Enrolment, each training session, 1 and 2 weeks post weaning
Secondary outcome [6] 268578 0
Functional level, measured via Acute Care Index of Function tool (therapist reported)
Timepoint [6] 268578 0
Enrolment
1 week post weaning for patients training whilst ventilated.
2 weeks post weaning for patients training post ventilatory weaning.
Secondary outcome [7] 268579 0
Duration of weaning (i.e. from commencement of pressure support only ventilation until 24 hours ventilator-free)
Timepoint [7] 268579 0
Day of successful weaning (24 hours ventilator-free)

Eligibility
Key inclusion criteria
All patients admitted to ICU who:
- are mechanically ventilated for 7days or longer
- are aged 16 years or older
- are alert and able to co-operate with training
- are able to provide informed consent
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from the study if they are:
- age < 16 years
- unwilling to consent
- previously included in the study
- pregnant
- mechanically ventilated less than 7days
- not alert or able to co-operate with training
- not able to provide informed consent
- requiring high levels of ventilatory support (eg PEEP > 15 cmH20, FiO2 > 0.60) where the treating team (medical and / or physiotherapy) deems risks of brief disconnection from ventilation unacceptable

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)
Patients will be randomised (computer generated random number sequence) to receive either inspiratory muscle training or usual physiotherapy care. Allocation will be concealed as the therapist identifying the subject as suitable for enrolment will subsequently contact the holder of the computer generated allocated schedule located off site.
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?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/01/2011
Actual
3/02/2011
Date of last participant enrolment
Anticipated
Actual
3/06/2019
Date of last data collection
Anticipated
Actual
31/10/2019
Sample size
Target
140
Accrual to date
Final
140
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3503 0
2605

Funding & Sponsors
Funding source category [1] 258181 0
Hospital
Name [1] 258181 0
Canberra Hospital
Country [1] 258181 0
Australia
Primary sponsor type
Individual
Name
Bernie Bissett
Address
Physiotherapy Department
Canberra Hospital
Yamba Drive
Garran ACT 2605
Country
Australia
Secondary sponsor category [1] 257357 0
Individual
Name [1] 257357 0
Dr Anne Leditschke
Address [1] 257357 0
Intensive Care Unit
Canberra Hospital
Yamba Drive
Garran ACT 2605
Country [1] 257357 0
Australia
Other collaborator category [1] 251723 0
Individual
Name [1] 251723 0
Ms Margot Green
Address [1] 251723 0
Physiotherapy Department
Canberra Hospital
Yamba Drive
Garran ACT 2605
Country [1] 251723 0
Australia
Other collaborator category [2] 251724 0
Individual
Name [2] 251724 0
Dr Jennifer Paratz
Address [2] 251724 0
Department of Intensive Care Medicine
Level 3, Ned Hanlon Building
Royal Brisbane and Women's Hospital
Bowen Bridge Road
Herston QLD 4011
Country [2] 251724 0
Australia
Other collaborator category [3] 251725 0
Individual
Name [3] 251725 0
Dr Robert Boots
Address [3] 251725 0
Department of Intensive Care Medicine
Level 3, Ned Hanlon Building
Royal Brisbane and Women's Hospital
Bowen Bridge Road
Herston QLD 4011
Country [3] 251725 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260174 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 260174 0
Ethics committee country [1] 260174 0
Australia
Date submitted for ethics approval [1] 260174 0
Approval date [1] 260174 0
10/11/2010
Ethics approval number [1] 260174 0
ETH.10.10.370
Ethics committee name [2] 260175 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [2] 260175 0
Ethics committee country [2] 260175 0
Australia
Date submitted for ethics approval [2] 260175 0
Approval date [2] 260175 0
24/11/2010
Ethics approval number [2] 260175 0
2010001488

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

Contacts
Principal investigator
Name 31998 0
Mrs Bernie Bissett
Address 31998 0
Physiotherapy Department
Canberra Hospital
Garran ACT 2605
Country 31998 0
Australia
Phone 31998 0
+6 2 6244 2154
Fax 31998 0
Email 31998 0
Bernie.Bissett@act.gov.au
Contact person for public queries
Name 15245 0
Bernie Bissett
Address 15245 0
Physiotherapy Department
Canberra Hospital
Yamba Drive
Garran ACT 2605
Country 15245 0
Australia
Phone 15245 0
+ 61 2 6244 2154
Fax 15245 0
+61 2 6244 3692
Email 15245 0
bernie.bissett@act.gov.au
Contact person for scientific queries
Name 6173 0
Bernie Bissett
Address 6173 0
Physiotherapy Department
Canberra Hospital
Yamba Drive
Garran ACT 2605
Country 6173 0
Australia
Phone 6173 0
+61 2 6244 2154
Fax 6173 0
+61 2 6244 3692
Email 6173 0
bernie.bissett@act.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not covered by ethics in 2010


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.