Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000155392
Ethics application status
Approved
Date submitted
9/07/2007
Date registered
2/04/2008
Date last updated
19/06/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of high and low level breathing support delivered via a mask during walking in patients with severe kyphoscoliosis
Scientific title
Effect of high and low level pressure support during walking on exercise endurance time in patients with severe kyphoscoliosis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe kyphoscoliosis 2986 0
Condition category
Condition code
Respiratory 3136 3136 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant performed 4 endurance treadmill tests within one day. One test was performed unassisted, one with continous positive airway pressure (CPAP) of 4cmH2O, one with low level pressure support (PS) of 10cmH2O and one with high level PS of 20cmH2O. Tests were performed in random order. Prior to performing each exercise test, participants rested in the sitting position for 10 minutes. Of the 10 minute rest period, participants breathed unassisted for the first 5 minues. For the second 5 minutes of rest, participants breathed on CPAP prior to the CPAP walk test, PS 10 prior to the PS 10 walk test, PS 20 prior to the PS 20 walk test, and a further 5 minute period of breathing unassisted prior to the unassisted walking test. Participants rested for at least 30 minutes while breathing unassisted between each exercise test (and until heart rate, blood pressure, breathlessness, oxygen saturation and exertion had returned to baseline). Participants only received CPAP, PS 10 and PS 20 for the duration of the endurance walk test and 5 minute rest period immediately prior to the walk test as described above.
Intervention code [1] 2726 0
Rehabilitation
Comparator / control treatment
High level pressure support (20cmH2O) versus low level pressure support (10cmH2O) versus continuous positive airway pressure (4cmH2O) versus Unassisted Exercise (control). The duration of the control was equivalent to the duration of the unassisted endurance walk test (this was the longest time that participants could walk for, ie. not a pre-determined period of time).
Control group
Active

Outcomes
Primary outcome [1] 4020 0
Endurance time (seconds)
Timepoint [1] 4020 0
End exercise
Secondary outcome [1] 6770 0
Isotime breathlessness
Timepoint [1] 6770 0
Isotime was defined as the duration of the shorter test. Breathlessness scores were compared at this point in time for unassisted, CPAP, low and high level pressure support tests

Eligibility
Key inclusion criteria
Severe kyphoscoliosis, on nocturnal domiciliary non-invasive ventilation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unstable during past month (admission to hospital, change in medications, change in respiratory symptoms), febrile, uncontrolled hypertension (SBP >160mmHg, DBP > 100mmHg), unstable angina or myocardial infarct in past month, resting HR >120bpm, major psychiatric illness, musculoskeletal or neurological conditions that significantly limit exercise, inability to give informed consent.

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)
Consent obtained from eligible participants attending review sleep study, prior to exercise testing investigator 1 (not blinded to order of CPAP, low and high breathing support tests, and who did not interact with participants during testing) opened the concealed envelope and set the non-invasive ventilation machine to sham, low or high level pressure support and covered the settings so that the participant and other investigators (2 and 3, who interacted with the participant) were blinded to the condition.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation website (randomization.com)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Participants and investigators (2 and 3) were blind to the type of breathing support provided during exercise tests with CPAP, low and high pressure support. Investigator 1 was not blind to the type of test however they did not interact with the participant during exercise tests. Investigator 1 assessed and analysed the results.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3251 0
Hospital
Name [1] 3251 0
Royal Prince Alfred Hospital
Country [1] 3251 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
East St
Lidcombe NSW 2141
Country
Australia
Secondary sponsor category [1] 2906 0
Hospital
Name [1] 2906 0
Royal Prince Alfred Hospital
Address [1] 2906 0
Level 11
E Block
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country [1] 2906 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5234 0
Sydney South West Area Health Service Human Ethics Committee
Ethics committee address [1] 5234 0
Research Development Office
Level 8
Building 14
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Ethics committee country [1] 5234 0
Australia
Date submitted for ethics approval [1] 5234 0
Approval date [1] 5234 0
26/04/2006
Ethics approval number [1] 5234 0
X06-0017

Summary
Brief summary
People with severe curvature of the spine (kyphoscoliosis) have a reduced exercise capacity and are often limited by their respiratory system. The aim of this study was to determine the effect of low level and high level breathing support (provided via a mask) during treadmill walking in people with severe curvature of the spine (kyphoscoliosis) compared to sham breathing support and walking unassisted. We hypothesised that only high level breathing support would increase exercise endurance time in people with severe kyphoscoliosis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27695 0
Address 27695 0
Country 27695 0
Phone 27695 0
Fax 27695 0
Email 27695 0
Contact person for public queries
Name 11070 0
Collette Menadue
Address 11070 0
C/- Sleep Unit
Level 11
E Block
Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050
Country 11070 0
Australia
Phone 11070 0
+61 2 95158708
Fax 11070 0
+61 2 95157196
Email 11070 0
[email protected]
Contact person for scientific queries
Name 1998 0
Collette Menadue
Address 1998 0
C/- Sleep Unit
Level 11
E Block
Royal Prince Alfred Hospital
Missenden Rd
Camperdown NSW 2050
Country 1998 0
Australia
Phone 1998 0
+61 2 95158708
Fax 1998 0
+61 2 95157196
Email 1998 0
[email protected]

No information has been provided regarding IPD availability


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.