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
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
ACTRN12613000804785
Ethics application status
Approved
Date submitted
16/07/2013
Date registered
22/07/2013
Date last updated
22/01/2020
Date data sharing statement initially provided
22/01/2020
Date results information initially provided
22/01/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Effect of non-invasive ventilation during exercise on dynamic hyperinflation in chronic obstructive pulmonary disease
Query!
Scientific title
The effect of non-invasive ventilation during exercise compared to unassisted breathing on dynamic hyperinflation in patients with chronic obstructive pulmonary disease
Query!
Secondary ID [1]
282830
0
Nil known
Query!
Universal Trial Number (UTN)
U1111-1145-6751
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
chronic obstructive pulmonary disease
289614
0
Query!
Condition category
Condition code
Respiratory
289952
289952
0
0
Query!
Chronic obstructive pulmonary disease
Query!
Physical Medicine / Rehabilitation
289973
289973
0
0
Query!
Physiotherapy
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
The trial will consist of three constant work rate Cardio Pulmonary Exercise Tests with and without Noninvasive Ventilation (BiLevel Positive Airway Pressure). The noninvasive ventilation will be administered once with a standard therapy and once with individually titrated expiratory pressure.
The expiratory pressure will be determined by asking the patient to sit and receive different levels of pressure and perform an inspiratory capacity maneuver at each pressure. The pressure which provides the biggest inspiratory capacity will be the titrated expiratory pressure.
This will be administered using a commercially available ventilator, the ResMed Stellar 150. The ventilator will be connected to the patient via a standard tube to a mask and a vent. The ventilator provides constant flow and a positive pressure to the mask. Both NIV arms will use the device in BiLevel pressure support mode. This mode has a square waveform with a high pressure during inspiration and a lower pressure during expiration. For both NIV arms, an inspiratory pressure of 15cmH2O will be used. The standard settings arm will use an expiratory pressure of 6cmH2O. The individual pressures will range from 2 - 10 cmH2O.
The constant work rate exercise protocol will be done on a cycle ergometer. The work rate will be set after one minute of unloaded pedaling and the patient will be asked to pedal to exhaustion. The patients are expected to exercise from 4 - 20 minutes.
The work rate will be chosen at 75% of the peak work rate found in an incremental maximal work rate test. The incremental test will be performed on the first day and the constant work rate tests will be in the subsequent days.
The 3 constant work rate exercise tests will be separated by at least 1 hour but must be completed within 7 days of beginning to prevent bias due to change in baseline health.
Query!
Intervention code [1]
287521
0
Rehabilitation
Query!
Intervention code [2]
287522
0
Treatment: Devices
Query!
Comparator / control treatment
Constant work rate exercise test with unassisted breathing (same test as with noninvasive ventilation)
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
290004
0
Change in inspiratory capacity measured by spirometry
The patients breathing will be monitored the entire test via a flow transducer placed at the outlet of the mask
Query!
Assessment method [1]
290004
0
Query!
Timepoint [1]
290004
0
End of exercise
Query!
Primary outcome [2]
290005
0
Endurance Time as measured by time since work load was added to the cycle ergometer
Query!
Assessment method [2]
290005
0
Query!
Timepoint [2]
290005
0
End of Exercise
Query!
Secondary outcome [1]
303761
0
Minute Ventilation as measured using spirometery
The patients breathing will be monitored the entire test via a flow transducer placed at the outlet of the mask
Query!
Assessment method [1]
303761
0
Query!
Timepoint [1]
303761
0
End of exercise
Query!
Eligibility
Key inclusion criteria
Diagnosis of severe to very severe COPD (FEV1/FVC < 70%, FEV1 < 50% predicted)
Stable over the past month (i.e. no admissions to hospital, change in medications or increase in respiratory symptoms)
Query!
Minimum age
No limit
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Concomitant cardiovascular, orthopaedic or neurological conditions that are likely to impair exercise performance
Other significant pulmonary disease (e.g. asthma)
Major psychiatric illness
Inability to give informed consent
BMI > 32 kg/m2
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)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Query!
Other design features
Query!
Phase
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Date of first participant enrolment
Anticipated
2/09/2013
Query!
Actual
9/05/2016
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
6/05/2019
Query!
Date of last data collection
Anticipated
Query!
Actual
20/05/2019
Query!
Sample size
Target
20
Query!
Accrual to date
Query!
Final
21
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment hospital [1]
9991
0
Royal Prince Alfred Hospital - Camperdown
Query!
Recruitment postcode(s) [1]
18831
0
2050 - Camperdown
Query!
Recruitment outside Australia
Country [1]
9570
0
Germany
Query!
State/province [1]
9570
0
Bavaria
Query!
Funding & Sponsors
Funding source category [1]
287616
0
University
Query!
Name [1]
287616
0
University of Sydney
Query!
Address [1]
287616
0
The University of Sydney
NSW 2006
Australia
Query!
Country [1]
287616
0
Australia
Query!
Primary sponsor type
University
Query!
Name
University of Sydney
Query!
Address
The University of Sydney
NSW 2006
Australia
Query!
Country
Australia
Query!
Secondary sponsor category [1]
286360
0
None
Query!
Name [1]
286360
0
Query!
Address [1]
286360
0
Query!
Country [1]
286360
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
289587
0
SLHD Ethics Review Committee (RPAH Zone)
Query!
Ethics committee address [1]
289587
0
50 Missenden Rd Camperdown NSW 2050
Query!
Ethics committee country [1]
289587
0
Australia
Query!
Date submitted for ethics approval [1]
289587
0
24/07/2013
Query!
Approval date [1]
289587
0
12/12/2013
Query!
Ethics approval number [1]
289587
0
Query!
Summary
Brief summary
AIM:
The aim of this study is to determine the effect of NIV during exercise on DHI (Dynamic HyperInflation) in people with COPD (Chronic Obstructive Pulmonary Disease) compared to exercise without NIV (Noninvasive Ventilation). NIV with two different settings, standard and individualised, will be compared with no NIV.
HYPOTHESIS:
Non-invasive ventilation during exercise will reduce dynamic hyperinflation and increase exercise endurance time in people with COPD who dynamically hyperinflate during exercise compared to exercise without NIV. Individualised NIV will be more effective than standard NIV and no NIV in reducing DHI during exercise.
POTENTIAL SIGNIFICANCE:
Breathlessness is a major symptom for patients with severe COPD impacting adversely on physical performance and quality of life. The immediate effects of NIV during exercise include significant improvements in breathlessness and exercise endurance beyond those achieved with unassisted breathing in selected patients with severe COPD. These acute effects could significantly improve the efficacy of a pulmonary rehabilitation program by enabling people with COPD to exercise for longer or at a higher intensity.
Query!
Trial website
Query!
Trial related presentations / publications
van't Hul, Alex, et al. "Acute effects of inspiratory pressure support during exercise in patients with COPD." European Respiratory Journal 23.1 (2004): 34-40.
Puente-Maestu, Luis, et al. "Clinical relevance of constant power exercise duration changes in COPD." European Respiratory Journal 34.2 (2009): 340-345.
Corner, Eve, and Rachel Garrod. "Does the addition of non-invasive ventilation during pulmonary rehabilitation in patients with chronic obstructive pulmonary disease augment patient outcome in exercise tolerance? A literature review."Physiotherapy Research International 15.1 (2010): 5-15.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
39970
0
Prof Jennifer Alison
Query!
Address
39970
0
Department of Physiotherapy, Royal Prince Alfred Hospital
Missenden Rd, Camperdown, Sydney, NSW, 2050
Query!
Country
39970
0
Australia
Query!
Phone
39970
0
+61 2 9515 9857
Query!
Fax
39970
0
Query!
Email
39970
0
[email protected]
Query!
Contact person for public queries
Name
39971
0
Mr Clancy Dennis
Query!
Address
39971
0
The University of Sydney
Faculty of Health Sciences
75 East St
Lidcombe
NSW
2141
Query!
Country
39971
0
Australia
Query!
Phone
39971
0
+61401216009
Query!
Fax
39971
0
Query!
Email
39971
0
[email protected]
Query!
Contact person for scientific queries
Name
39972
0
Mr Clancy Dennis
Query!
Address
39972
0
The University of Sydney
Faculty of Health Sciences
75 East St
Lidcombe
NSW
2141
Query!
Country
39972
0
Australia
Query!
Phone
39972
0
+61401216009
Query!
Fax
39972
0
Query!
Email
39972
0
[email protected]
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
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
6537
Study protocol
[email protected]
6538
Ethical approval
[email protected]
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Bilevel Noninvasive Ventilation During Exercise Reduces Dynamic Hyperinflation and Improves Cycle Endurance Time in Severe to Very Severe COPD.
2021
https://dx.doi.org/10.1016/j.chest.2021.06.050
N.B. These documents automatically identified may not have been verified by the study sponsor.
Download to PDF