Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000215628
Ethics application status
Approved
Date submitted
24/08/2005
Date registered
25/08/2005
Date last updated
21/01/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Early rehabilitation in patients with hypercapnic respiratory failure.
Scientific title
The effect of early exercise rehabilitation on exercise capacity and dyspnoea in patients with hypercapnic respiratory failure
Secondary ID [1] 253454 0
Not applicable
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypercapnic respiratory failure 298 0
Condition category
Condition code
Respiratory 337 337 0 0
Other respiratory disorders / diseases
Physical Medicine / Rehabilitation 338 338 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will be conducted over a 6-8 day period during a hospital admission for hypercapnic respiratory failure. On day 1, baseline anthropometric data, measurement of exercise capacity, quality of life, an arterial blood gas, spirometry and maximum inspiratory and expiratory muscle pressures at the mouth were collected. Day 2 subjects were randomised to either a control or early exercise rehabilitation with supplemental oxygen or early exercise rehabilitation group (with non-invasive ventilation and supplemental oxygen). All groups receive standard medical care, including non-invasive ventilation at rest as required. Early rehabilitation consists of a supervised, progressive exercise program of approximately 20-30 minutes each day for at least 4 days. Day 6-8 baseline measures repeated.
Intervention code [1] 236 0
None
Comparator / control treatment
Control group does not receive any exercise rehabilitation during the trial.
Control group
Active

Outcomes
Primary outcome [1] 393 0
Exercise capacity - measured by the 6MWT and an unsupported arm endurance test
Timepoint [1] 393 0
Comparisons made within group pre and post intervention, and between groups pre and post intervention, and in proportion of change from pre-post intervention
Primary outcome [2] 394 0
Dyspnoea - using Borg dysponea scale (0-10)
Timepoint [2] 394 0
Comparisons made within group pre and post intervention, and between groups pre and post intervention, and in proportion of change from pre-post intervention
Secondary outcome [1] 861 0
SpO2% - using pulse oximeter
Timepoint [1] 861 0
Measured continuously throughout exercise
Secondary outcome [2] 862 0
Rate of perceived exertion - using Borg RPE scale (0-10)
Timepoint [2] 862 0
Measured each minute during exercise tests
Secondary outcome [3] 863 0
Quality of life - using St Georges Respiratory Questionnaire (SGRQ) and the Maugeri Foundation Respiratory Failure Questionnaire (MRF-28)
Timepoint [3] 863 0
Measured pre and post training and at three month review

Eligibility
Key inclusion criteria
Daytime PaCO2 greater than 45mmHg, pH greater than 7.34, 3 out of 4 of : increase in FiO2 required to maintain SpO2 greater than 90% compared to baseline, increase in dyspnoea in the past week, increase in cough/sputum past week, decrease in subjective exercise tolerance over past week.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
pH equal to or less than 7.34, gross hypoxaemia, unstable angina or myocardial infarct in previous month, uncontrolled hypertension, febrile, resting tachycardia, orthopaedic or neurological conditions that limit exercise capacity, decreased level of conciousness, major psychiatric illness.

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)
sealed numbered opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random number generation on a computer, (stratified block randomisation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
12/05/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 396 0
Government body
Name [1] 396 0
Australian Postgraduate Award (APA) NSW Government 2004-2007
Country [1] 396 0
Australia
Funding source category [2] 397 0
Government body
Name [2] 397 0
Ian Collier Memorial Scholarship (NSW Physiotherapy Registration Board) 2004
Country [2] 397 0
Australia
Funding source category [3] 398 0
Charities/Societies/Foundations
Name [3] 398 0
Physiotherapy Research Foundation (Australian Physiotherapy Association) 2004
Country [3] 398 0
Australia
Funding source category [4] 399 0
Charities/Societies/Foundations
Name [4] 399 0
George Burniston Cumberland Foundation Fellowship 2005
Country [4] 399 0
Australia
Primary sponsor type
Other
Name
Royal Prince Alfred Hospital, Woolcock Institute of Medical Research, University of Sydney
Address
Department of Respiratory and Sleep Medicine, Royal Prince Alfred Hospital, Missenden Rd, Camperdown NSW 2050, Australia
Country
Australia
Secondary sponsor category [1] 324 0
None
Name [1] 324 0
nil
Address [1] 324 0
Country [1] 324 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1386 0
Royal Prince Alfred Hospital (Sydney South West Area Health Service) University of Sydney
Ethics committee address [1] 1386 0
Ethics committee country [1] 1386 0
Australia
Date submitted for ethics approval [1] 1386 0
Approval date [1] 1386 0
Ethics approval number [1] 1386 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35990 0
Address 35990 0
Country 35990 0
Phone 35990 0
Fax 35990 0
Email 35990 0
Contact person for public queries
Name 9425 0
Ms Wendy Taylor
Address 9425 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 9425 0
Australia
Phone 9425 0
+61 2 95156578
Fax 9425 0
+61 2 95505865
Email 9425 0
volunteers@woolcock.org.au
Contact person for scientific queries
Name 353 0
Ms Collette Menadue
Address 353 0
Sleep Unit
Royal Prince Alfred Hospital
Level 11 E Block
Missenden Road
Camperdown NSW 2050
Country 353 0
Australia
Phone 353 0
+61 2 95158708
Fax 353 0
+61 2 95157691
Email 353 0
collette@med.usyd.edu.au

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.