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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
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of non-invasive ventilation during exercise on dynamic hyperinflation in chronic obstructive pulmonary disease
Scientific title
The effect of non-invasive ventilation during exercise compared to unassisted breathing on dynamic hyperinflation in patients with chronic obstructive pulmonary disease
Secondary ID [1] 282830 0
Nil known
Universal Trial Number (UTN)
U1111-1145-6751
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic obstructive pulmonary disease 289614 0
Condition category
Condition code
Respiratory 289952 289952 0 0
Chronic obstructive pulmonary disease
Physical Medicine / Rehabilitation 289973 289973 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 287521 0
Rehabilitation
Intervention code [2] 287522 0
Treatment: Devices
Comparator / control treatment
Constant work rate exercise test with unassisted breathing (same test as with noninvasive ventilation)
Control group
Active

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
Timepoint [1] 290004 0
End of exercise
Primary outcome [2] 290005 0
Endurance Time as measured by time since work load was added to the cycle ergometer
Timepoint [2] 290005 0
End of Exercise
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
Timepoint [1] 303761 0
End of exercise

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)
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/09/2013
Actual
9/05/2016
Date of last participant enrolment
Anticipated
Actual
6/05/2019
Date of last data collection
Anticipated
Actual
20/05/2019
Sample size
Target
20
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9991 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 18831 0
2050 - Camperdown
Recruitment outside Australia
Country [1] 9570 0
Germany
State/province [1] 9570 0
Bavaria

Funding & Sponsors
Funding source category [1] 287616 0
University
Name [1] 287616 0
University of Sydney
Country [1] 287616 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney
NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 286360 0
None
Name [1] 286360 0
Address [1] 286360 0
Country [1] 286360 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289587 0
SLHD Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 289587 0
50 Missenden Rd Camperdown NSW 2050
Ethics committee country [1] 289587 0
Australia
Date submitted for ethics approval [1] 289587 0
24/07/2013
Approval date [1] 289587 0
12/12/2013
Ethics approval number [1] 289587 0

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.
Trial website
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.
Public notes

Contacts
Principal investigator
Name 39970 0
Prof Jennifer Alison
Address 39970 0
Department of Physiotherapy, Royal Prince Alfred Hospital
Missenden Rd, Camperdown, Sydney, NSW, 2050
Country 39970 0
Australia
Phone 39970 0
+61 2 9515 9857
Fax 39970 0
Email 39970 0
[email protected]
Contact person for public queries
Name 39971 0
Clancy Dennis
Address 39971 0
The University of Sydney
Faculty of Health Sciences
75 East St
Lidcombe
NSW
2141
Country 39971 0
Australia
Phone 39971 0
+61401216009
Fax 39971 0
Email 39971 0
[email protected]
Contact person for scientific queries
Name 39972 0
Clancy Dennis
Address 39972 0
The University of Sydney
Faculty of Health Sciences
75 East St
Lidcombe
NSW
2141
Country 39972 0
Australia
Phone 39972 0
+61401216009
Fax 39972 0
Email 39972 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6537Study protocol  [email protected]
6538Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseBilevel Noninvasive Ventilation During Exercise Reduces Dynamic Hyperinflation and Improves Cycle Endurance Time in Severe to Very Severe COPD.2021https://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.