Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000929808
Ethics application status
Approved
Date submitted
30/08/2012
Date registered
31/08/2012
Date last updated
17/01/2023
Date data sharing statement initially provided
2/12/2019
Date results information initially provided
2/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Threshold respiratory muscle training in people with cervical spinal cord injury: a randomised double-blind placebo controlled trial.
Scientific title
Respiratory muscle training for people with a cervical spinal cord injury to improve muscle strength and lung function.
Secondary ID [1] 280962 0
Nil
Universal Trial Number (UTN)
Trial acronym
RMT-SCI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury 287071 0
Condition category
Condition code
Neurological 287395 287395 0 0
Other neurological disorders
Injuries and Accidents 287628 287628 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Respiratory muscle training which involves inhaling and exhaling through a threshold muscle training device for 15 minutes, twice a day for six weeks, the internal resistance of the device is increased weekly by 5%.
Intervention code [1] 285401 0
Treatment: Devices
Comparator / control treatment
Sham respiratory muscle training - subjects breathe through a device that is identical in appearance to the muscle trainer but unlike the intervention the internal resistance of the device is not altered over the study period.
Control group
Placebo

Outcomes
Primary outcome [1] 287717 0
Maximal inspiratory pressure using a respiratory pressure meter.
Timepoint [1] 287717 0
Weeks 0, 1, 2, 3, 4, 5, 6, 52
Secondary outcome [1] 298694 0
Modified Borg scale
Timepoint [1] 298694 0
Weeks 0, 1, 2, 3, 4, 5, 6, 52
Secondary outcome [2] 298696 0
Number of respiratory complications including pulmonary emboli, pneumonia, requirements for increases in non-invasive ventilation or return to mechanical ventilation.
Timepoint [2] 298696 0
Weeks 0, 6, 52
Secondary outcome [3] 298697 0
Respiratory function (forced vital capacity, vital capacity, tidal volume, total lung capacity, functional residual capacity, residual volume, inspiratory capacity, forced expiratory volume in one second, maximal expiratory pressure) using spirometry.
Timepoint [3] 298697 0
Weeks 0, 6, 52
Secondary outcome [4] 298698 0
Respiratory load detection and effort rating using a customised chamber resistance circuit where the load increments linearly along the chambers and effort is rated using the modified Borg scale.
Timepoint [4] 298698 0
Weeks 0, 6, 52
Secondary outcome [5] 298699 0
Diaphragm single motor unit discharge rates using an intramuscular electrode.
Timepoint [5] 298699 0
Weeks 0, 6, 52
Secondary outcome [6] 298700 0
Health Related quality of life (Short Form 36/ walk-wheel validated for people with spinal cord injuries).
Timepoint [6] 298700 0
Weeks 0, 6, 52
Secondary outcome [7] 298972 0
Polysomnography (number of apnoeic episodes per hour, number of arousals from sleep, blood oxygen desaturation levels)
Timepoint [7] 298972 0
Weeks 0, 6, 52
Secondary outcome [8] 298973 0
Sniff nasal inspiratory pressure using a respiratory pressure meter.
Timepoint [8] 298973 0
Weeks 0, 6, 52

Eligibility
Key inclusion criteria
Cervical spinal cord injury (AIS A, B or C) of at least 6 weeks duration.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients requiring mechanical ventilation; pregnancy; diagnosis of a significant co-existing respiratory or neurological illness; patients with a cognitive impairment.

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)
Potential participants will be provided with the information and consent form. All procedures, treatments and assessments will be explained thoroughly by a researcher involved in the trial. Potential participants will be given opportunity to ask questions and decide if and when they wish to participate in the trial. Allocation to the treatment will be performed by computer generated random allocation with concealment. Allocation involved contacting the holder of the allocation schedule who was “off-site” or at central administration site.
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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2012
Actual
10/01/2014
Date of last participant enrolment
Anticipated
31/01/2017
Actual
4/11/2016
Date of last data collection
Anticipated
Actual
26/01/2018
Sample size
Target
80
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 285903 0
Charities/Societies/Foundations
Name [1] 285903 0
Prince of Wales Hospital Foundation
Country [1] 285903 0
Australia
Primary sponsor type
Other
Name
Neuroscience Research Australia
Address
Barker Street
Randwick
NSW 2031
Country
Australia
Secondary sponsor category [1] 284725 0
Hospital
Name [1] 284725 0
Prince of Wales Hospital
Address [1] 284725 0
Barker Street
Randwick
NSW 2031
Country [1] 284725 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287930 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 287930 0
Room G71 East Wing
Edmund Blacket Building
Prince of Wales Hospital
Barker Street
Randwick NSW 2031
Ethics committee country [1] 287930 0
Australia
Date submitted for ethics approval [1] 287930 0
10/09/2012
Approval date [1] 287930 0
16/01/2013
Ethics approval number [1] 287930 0
HREC ref no: 12/192 (LNR/12/POWH/409)
Ethics committee name [2] 290973 0
UNSW HREC
Ethics committee address [2] 290973 0
Ethics Secretariat
University of New South Wales
Sydney NSW 2052
Australia
Ethics committee country [2] 290973 0
Australia
Date submitted for ethics approval [2] 290973 0
Approval date [2] 290973 0
10/01/2014
Ethics approval number [2] 290973 0
HC13388

Summary
Brief summary
The purpose of this study is to strengthen the muscles that people with a spinal cord injury uses to breathe. The training would involve taking deep breaths in and out through a small handheld device to exercise the muscles used to breathe. The training will be in addition to the usual care received by each person. The training will be carried out by an experienced and qualified person for 15 minutes, twice a day, five times a week for a duration of 6 weeks. It is hypothesized that this training will strengthen the muscles used to breathe resulting is fewer lung complications while in hospital and at home. Outcomes will be reassessed after one year.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34525 0
Dr Claire Boswell-Ruys
Address 34525 0
Neuroscience Research Australia
Barker Street
Randwick NSW 2031
Country 34525 0
Australia
Phone 34525 0
+61 2 93991841
Fax 34525 0
Email 34525 0
[email protected]
Contact person for public queries
Name 17772 0
Dr Claire Boswell-Ruys
Address 17772 0
Neuroscience Research Australia
Barker Street
Randwick
NSW 2031
Country 17772 0
Australia
Phone 17772 0
+61 2 93991841
Fax 17772 0
Email 17772 0
[email protected]
Contact person for scientific queries
Name 8700 0
Dr Claire Boswell-Ruys
Address 8700 0
Neuroscience Research Australia
Barker Street
Randwick
NSW 2031
Country 8700 0
Australia
Phone 8700 0
+61 2 93991841
Fax 8700 0
Email 8700 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
5973Study protocol  [email protected]
5974Clinical study report  [email protected]



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes C.L. BOSWELL-RUYS, C LEWIS, N. WIJEYSURIYA, R.A. ... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImpact of respiratory muscle training on respiratory muscle strength, respiratory function and quality of life in individuals with tetraplegia: A randomised clinical trial.2020https://dx.doi.org/10.1136/thoraxjnl-2019-213917
EmbaseComparison of two inspiratory muscle training protocols in people with spinal cord injury: a secondary analysis.2023https://dx.doi.org/10.1038/s41394-023-00594-2
N.B. These documents automatically identified may not have been verified by the study sponsor.