Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000105448
Ethics application status
Approved
Date submitted
11/01/2016
Date registered
1/02/2016
Date last updated
1/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Fatigue resistance index of inspiratory muscles – what is normal in a healthy population?
Scientific title
Fatigue resistance index of inspiratory muscles – what is normal in a healthy population?
Secondary ID [1] 288275 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inspiratory muscle endurance in healthy adults 297226 0
Condition category
Condition code
Respiratory 297430 297430 0 0
Normal development and function of the respiratory system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To quantify inspiratory muscle endurance, through the Fatigue Resistance Index method, in healthy people in a one off session. The procedure is identical to that performed in the previous studies in intensive care at Canberra Hospital. To perform the testing, participants will need to ‘empty their lungs’, then inhale maximally through a hand-held device (MircoRPM Respiratory Pressure Metre) for 1 to 2 seconds. This will be repeated 3 times to ensure reliability. The participant will then breathe through an inspiratory muscle trainer (Threshold IMT) for 2 minutes at a resistance equivalent to 30% of their maximum effort. The participant will then repeat the 3 maximum inhalations through the hand-held MicroRPM machine. Thus a total of 6 maximal breaths is required for testing, i.e. 3 breaths either side of the 2 minute resistance challenge. Participants will be monitored closely and testing ceased if not tolerated at any point. Total testing time should take less than 15 minutes allowing for explanation and rest time.

Intervention code [1] 293567 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296988 0
To quantify inspiratory muscle endurance, through the Fatigue Resistance Index method, in healthy people.
Timepoint [1] 296988 0
In a one off session.
Secondary outcome [1] 319812 0
The Borg Rate of Perceived Exertion whilst undertaking the Fatigue Resistance Index
Timepoint [1] 319812 0
Taken during the one off session; immediately before the first measure of Maximal Inspiratory Pressure, immediately after the completion of the 2 minute breathing challenge and at cessation of testing immediately after the final measure for Maximal Inspiratory Pressure is taken.

Eligibility
Key inclusion criteria
Healthy adults, with no known respiratory disease, who have not undertaken any form of inspiratory muscle training. Healthy adults who are able to communicate and provide consent to perform testing.
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded it they already suffer from lung disease (eg Chronic Obstructive Lung Disease, Asthma or Cystic Fibrosis). These pathologies are likely to affect the strength and endurance of inspiratory muscles, and would therefore contaminate the sample of healthy participants.

Participants will also be excluded if they already participate in any form of inspiratory muscle training as this is likely to affect the Maximal Inspiratory Pressure manoeuvre used in the FRI test, and would not represent usual respiratory muscle activity for a healthy person (i.e. they are likely to have supra-normal results).

Participants will be excluded if they cannot communicate sufficiently to provide consent or perform testing.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive analysis will be used for all data using Statistical Package for Social Sciences (SPSS) version 22. Correlation between FRI scores of healthy participants and ICU patients will be described using intra-class correlation coefficients and Pearson’s correlation as appropriate. Significance level will be set at p < 0.05. Analysis will be performed in collaboration with Dr Teresa Neeman at the ANU.
To allow comparison with our sample from ICU patients, we will aim to recruit 45 participants aged 20 – 90, recruiting both males and females to allow age and gender matching to our intensive care patients as much as possible.
The ICU sample that we shall be comparing it to is detailed in the attached reference. In this study the sample size was calculated to be 16 to detect a change of 10% MIP when measuring FRI (correlation co-efficient of >0.06). This study took FRI measures from 43 patients in an ICU setting. The aim of the proposed study is to compare the data between the ICU patients and the FRI scores of health adults.
Reference: Bissett B, Ledtischke IA, Boots R & Paratz J. Weaned but weary: one third of adult intensive care patients mechanically ventilated for 7 days or more have impaired inspiratory muscle endurance after successful weaning. Heart and Lung. 2015; 44: 15 – 20.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/02/2016
Actual
Date of last participant enrolment
Anticipated
31/03/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 292654 0
University
Name [1] 292654 0
University of Canberra
Country [1] 292654 0
Australia
Primary sponsor type
Individual
Name
Elizabeth Kilpatrick
Address
Faculty of Health
University of Canberra
University Drive
Bruce
ACT
2601
Country
Australia
Secondary sponsor category [1] 291372 0
Individual
Name [1] 291372 0
Bernie Bissett
Address [1] 291372 0
Faculty of Health
University of Canberra
University Drive
Bruce
ACT
2601
Country [1] 291372 0
Australia
Secondary sponsor category [2] 291373 0
Individual
Name [2] 291373 0
Dr Nicole Freene
Address [2] 291373 0
Faculty of Health
University of Canberra
University Drive
Bruce
ACT
2601
Country [2] 291373 0
Australia
Other collaborator category [1] 278762 0
Individual
Name [1] 278762 0
Dr Teresa Neeman
Address [1] 278762 0
The Australian National University
Acton
Canberra
ACT
2601
Country [1] 278762 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294128 0
Human Research Ethics Committee
Ethics committee address [1] 294128 0
University of Canberra
University Drive
Bruce
ACT
2617
Ethics committee country [1] 294128 0
Australia
Date submitted for ethics approval [1] 294128 0
01/09/2015
Approval date [1] 294128 0
06/10/2015
Ethics approval number [1] 294128 0
15-203

Summary
Brief summary
To quantify inspiratory muscle endurance, through the Fatigue Resistance Index method, in healthy people.
Poor respiratory muscle endurance is a consequence of invasive mechanical ventilation for patients in intensive care (1,2). Over the past 10 years, researchers including ourselves (2,3) have used the ‘Fatigue Resistance Index’ (FRI) method to quantify the endurance of the respiratory muscles of intensive care patients. This involves inhaling through a hand-held device for 2 seconds, then breathing against resistance for 2 minutes, and then inhaling maximally through the hand-held device again. The FRI is a feasible alternative to more complex invasive methods of analysing diaphragmatic endurance.
However, to our knowledge, this method of quantifying endurance has not been tested in a normal population. Following our publication in 2015 (1), we wish to measure FRI in normal healthy subjects to allow us to compare our data from intensive care patients with age and gender matched healthy participants.

REFERENCES:
1. Bissett B, Ledtischke IA, Boots R & Paratz J. Weaned but weary: one third of adult intensive care patients mechanically ventilated for 7 days or more have impaired inspiratory muscle endurance after successful weaning. Heart and Lung. 2015; 44: 15 – 20.
2. Chang AT, Boots RJ, Brown MG, Paratz J, Hodges PW. Reduced inspiratory muscle endurance following successful weaning from prolonged mechanical ventilation. Chest. 2005; 128: 553 – 559.
3. Bissett BM, Leditschke IA, Paratz JD, Boots RJ. Protocol: inspiratory muscle training for promoting recovery and outcomes in ventilated patients (IMPROVe): a randomised controlled trial. BMJ Open. 2012:2e000813.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 692 692 0 0
/AnzctrAttachments/369884-FRI in Normals UC Ethics September 2015.pdf
Attachments [2] 693 693 0 0
/AnzctrAttachments/369884-Faculty of Health Research Support Application 1 2015_FRI validity testing.doc
Attachments [3] 694 694 0 0
/AnzctrAttachments/369884-15-203_Bissett_Approved_Letter.pdf

Contacts
Principal investigator
Name 62594 0
Ms Elizabeth Kilpatrick
Address 62594 0
Faculty of Health
University of Canberra
University Drive
Bruce
ACT
2601
Country 62594 0
Australia
Phone 62594 0
+61448682080
Fax 62594 0
Email 62594 0
[email protected]
Contact person for public queries
Name 62595 0
Ms Elizabeth Kilpatrick
Address 62595 0
Faculty of Health
University of Canberra
University Drive
Bruce
ACT
2601
Country 62595 0
Australia
Phone 62595 0
+61448682080
Fax 62595 0
Email 62595 0
[email protected]
Contact person for scientific queries
Name 62596 0
Ms Elizabeth Kilpatrick
Address 62596 0
Faculty of Health
University of Canberra
University Drive
Bruce
ACT
2601
Country 62596 0
Australia
Phone 62596 0
+61448682080
Fax 62596 0
Email 62596 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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