Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
Please note that the ANZCTR website will be unavailable from 1pm to 2pm on Monday the 29th of April for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Date results information 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
Query!
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?
Query!
Secondary ID [1]
253255
0
ACT Health Human Research Ethics Committee: ETH 10.10.370
Query!
Secondary ID [2]
253256
0
University of Queensland Human Research Ethics Committee: 2010001488
Query!
Universal Trial Number (UTN)
U1111-1118-4554
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Inspiratory muscle weakness associated with long-term (> 7 days) ventilator dependence
258784
0
Query!
Condition category
Condition code
Respiratory
258924
258924
0
0
Query!
Other respiratory disorders / diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
257723
0
Treatment: Devices
Query!
Comparator / control treatment
Usual physiotherapy treatment (deep breathing exercises)
Query!
Control group
Active
Query!
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
Query!
Assessment method [1]
259789
0
Query!
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
Query!
Primary outcome [2]
259790
0
Health related quality of life, measured using SF-36v2 and EQ-5D tools (self-reported)
Query!
Assessment method [2]
259790
0
Query!
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
Query!
Primary outcome [3]
259791
0
Maximum inspiratory pressure (MIP) measured via a portable MicroRPM Respiratory Pressure meter
Query!
Assessment method [3]
259791
0
Query!
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
Query!
Secondary outcome [1]
268572
0
Duration of ventilation
Query!
Assessment method [1]
268572
0
Query!
Timepoint [1]
268572
0
Day of successful weaning (24 hours ventilator-free)
Query!
Secondary outcome [2]
268573
0
Length of ICU stay
Query!
Assessment method [2]
268573
0
Query!
Timepoint [2]
268573
0
Day of discharge from ICU
Query!
Secondary outcome [3]
268574
0
Rate of reintubation (i.e. % reintubated within 48 hours of extubation)
Query!
Assessment method [3]
268574
0
Query!
Timepoint [3]
268574
0
On study completion
Query!
Secondary outcome [4]
268576
0
Cortisol, creatinine and urea measurements via 24 hour urine sampling
Query!
Assessment method [4]
268576
0
Query!
Timepoint [4]
268576
0
On enrolment and 7 days later for those training whilst ventilated
Query!
Secondary outcome [5]
268577
0
Dyspnea - at rest and during training measured via modified borg scale (patient reprted)
Query!
Assessment method [5]
268577
0
Query!
Timepoint [5]
268577
0
Enrolment, each training session, 1 and 2 weeks post weaning
Query!
Secondary outcome [6]
268578
0
Functional level, measured via Acute Care Index of Function tool (therapist reported)
Query!
Assessment method [6]
268578
0
Query!
Timepoint [6]
268578
0
Enrolment
1 week post weaning for patients training whilst ventilated.
2 weeks post weaning for patients training post ventilatory weaning.
Query!
Secondary outcome [7]
268579
0
Duration of weaning (i.e. from commencement of pressure support only ventilation until 24 hours ventilator-free)
Query!
Assessment method [7]
268579
0
Query!
Timepoint [7]
268579
0
Day of successful weaning (24 hours ventilator-free)
Query!
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
Query!
Minimum age
16
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
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.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random number sequence
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
3/01/2011
Query!
Actual
3/02/2011
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
3/06/2019
Query!
Date of last data collection
Anticipated
Query!
Actual
31/10/2019
Query!
Sample size
Target
140
Query!
Accrual to date
Query!
Final
140
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment postcode(s) [1]
3503
0
2605
Query!
Funding & Sponsors
Funding source category [1]
258181
0
Hospital
Query!
Name [1]
258181
0
Canberra Hospital
Query!
Address [1]
258181
0
Yamba Drive
Garran ACT 260
Query!
Country [1]
258181
0
Australia
Query!
Primary sponsor type
Individual
Query!
Name
Bernie Bissett
Query!
Address
Physiotherapy Department
Canberra Hospital
Yamba Drive
Garran ACT 2605
Query!
Country
Australia
Query!
Secondary sponsor category [1]
257357
0
Individual
Query!
Name [1]
257357
0
Dr Anne Leditschke
Query!
Address [1]
257357
0
Intensive Care Unit
Canberra Hospital
Yamba Drive
Garran ACT 2605
Query!
Country [1]
257357
0
Australia
Query!
Other collaborator category [1]
251723
0
Individual
Query!
Name [1]
251723
0
Ms Margot Green
Query!
Address [1]
251723
0
Physiotherapy Department
Canberra Hospital
Yamba Drive
Garran ACT 2605
Query!
Country [1]
251723
0
Australia
Query!
Other collaborator category [2]
251724
0
Individual
Query!
Name [2]
251724
0
Dr Jennifer Paratz
Query!
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
Query!
Country [2]
251724
0
Australia
Query!
Other collaborator category [3]
251725
0
Individual
Query!
Name [3]
251725
0
Dr Robert Boots
Query!
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
Query!
Country [3]
251725
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
260174
0
ACT Health Human Research Ethics Committee
Query!
Ethics committee address [1]
260174
0
Building 10, Level 6, ACT Health Research Office
Canberra Hospital
Yamba Drive
Garran ACT 2605
Query!
Ethics committee country [1]
260174
0
Australia
Query!
Date submitted for ethics approval [1]
260174
0
Query!
Approval date [1]
260174
0
10/11/2010
Query!
Ethics approval number [1]
260174
0
ETH.10.10.370
Query!
Ethics committee name [2]
260175
0
University of Queensland Medical Research Ethics Committee
Query!
Ethics committee address [2]
260175
0
The University of Queensland
Cumbrae-Stewart Building
Research Road
Brisbane Qld 4072 Australia
Query!
Ethics committee country [2]
260175
0
Australia
Query!
Date submitted for ethics approval [2]
260175
0
Query!
Approval date [2]
260175
0
24/11/2010
Query!
Ethics approval number [2]
260175
0
2010001488
Query!
Summary
Brief summary
This study formally investigates specific breathing exercises, using a threshold device, for patients who require a breathing machine. It is hoped that the study will demonstrate that this training reduces breathing muscle weakness and also enhances quality of life, with significant improvements even 2 weeks following weaning from the breathing machine. The results of this study will guide physiotherapists in the optimal treatment of breathing muscle weakness for patients who have needed a breathing machine.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
31998
0
Mrs Bernie Bissett
Query!
Address
31998
0
Physiotherapy Department
Canberra Hospital
Garran ACT 2605
Query!
Country
31998
0
Australia
Query!
Phone
31998
0
+6 2 6244 2154
Query!
Fax
31998
0
Query!
Email
31998
0
Bernie.Bissett@act.gov.au
Query!
Contact person for public queries
Name
15245
0
Mrs Bernie Bissett
Query!
Address
15245
0
Physiotherapy Department
Canberra Hospital
Yamba Drive
Garran ACT 2605
Query!
Country
15245
0
Australia
Query!
Phone
15245
0
+ 61 2 6244 2154
Query!
Fax
15245
0
+61 2 6244 3692
Query!
Email
15245
0
bernie.bissett@act.gov.au
Query!
Contact person for scientific queries
Name
6173
0
Mrs Bernie Bissett
Query!
Address
6173
0
Physiotherapy Department
Canberra Hospital
Yamba Drive
Garran ACT 2605
Query!
Country
6173
0
Australia
Query!
Phone
6173
0
+61 2 6244 2154
Query!
Fax
6173
0
+61 2 6244 3692
Query!
Email
6173
0
bernie.bissett@act.gov.au
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Not covered by ethics in 2010
Query!
What supporting documents are/will be available?
No other documents available
Query!
Summary results
Have study results been published in a peer-reviewed journal?
No
Query!
Other publications
Have study results been made publicly available in another format?
No
Query!
Results – basic reporting
Query!
Results – plain English summary
Query!
Download to PDF