Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000147381
Ethics application status
Approved
Date submitted
20/03/2008
Date registered
27/03/2008
Date last updated
13/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise for people with dust-related lung disease.
Scientific title
Effect of exercise training compared to no training on quality of life and exercise capacity in people with
dust-related lung diseases.
Secondary ID [1] 287887 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subjects will have a medical diagnosis of lung disease from dust inhalation including silicosis, asbestosis or asbestos related
pleural disease (ARPD). 2951 0
Condition category
Condition code
Respiratory 3091 3091 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Supervised exercise training for the lower limb, 3 times weekly for 8 weeks. Lower limb exercise training will consist of at least 15 minutes of stationary cycling at 60% peak workrate achieved on the incremental cycle test and 15 minutes of walking training at 80% of the average walking speed achieved on the six minute walk test. Training duration will be uncreased to 20 minutes of cycling and 20 minutes of walking by the 12th training session.
Intervention code [1] 2683 0
Rehabilitation
Comparator / control treatment
Usual medical care with no exercise training or advice on exercise training for 8 weeks. Usual care - management of medications by general practitioner (GP) and possibly respiratory physician.
Control group
Active

Outcomes
Primary outcome [1] 3978 0
1) functional exercise capacity: six minute walk distance from the six minute walk test
Timepoint [1] 3978 0
baseline, immediately following the 8 weeks of intervention, and at 6 months
Primary outcome [2] 3979 0
2) Total quality of life score from the chronic respiratory disease questionnaire
Timepoint [2] 3979 0
Baseline, immediately following the 8 weeks of intervention, and at 6 months
Secondary outcome [1] 6691 0
1) Peak work capacity from an incremental cycle test (with other peak metabolic measurements)
Timepoint [1] 6691 0
baseline and immediately following the 8 weeks of intervention
Secondary outcome [2] 6692 0
2) Endurance time from an endurance cycle test
Timepoint [2] 6692 0
baseline and immediately following the 8 weeks of intervention
Secondary outcome [3] 6693 0
3) Isotime ventilation from the endurance cycle test
Timepoint [3] 6693 0
baseline and immediately following the 8 weeks of intervention
Secondary outcome [4] 6694 0
Generic health status- Short Form Health Survey (SF-36)
Timepoint [4] 6694 0
Baseline, immediately following the 8 weeks of intervention, and at 6 months
Secondary outcome [5] 6695 0
4) Anxiety and Depression - Hospital Anxiety and Depression Scale
Timepoint [5] 6695 0
Baseline, immediately following the 8 weeks of intervention, and at 6 months
Secondary outcome [6] 6696 0
3) Quality of Life: St George's Hospital Respiratory Questionnaire
Timepoint [6] 6696 0
Baseline, immediately following the 8 weeks of intervention, and at 6 months
Secondary outcome [7] 242236 0
SenseWear Armband: wear for seven days at baseline and immediately following the 8 weeks of intervention
Timepoint [7] 242236 0
Wear for seven days at baseline, immediately following the 8 weeks of intervention, and at 6 months

Eligibility
Key inclusion criteria
Subjects will have a medical diagnosis of lung disease from dust inhalation including silicosis, asbestosis or asbestos related
pleural disease (ARPD). Subjects on long-term oxygen therapy will be included in
the study.
Minimum age
35 Years
Maximum age
86 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects will be excluded if they have any
musculoskeletal, cardiovascular or neurological conditions likely to adversely
affect performance during exercise assessment or training; have an inability to
understand English; or have participated in a pulmonary rehabilitation program
within the last 12 months.

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)
Subjects will be randomised after initial baseline testing by a computer program. Allocation will be concealed by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer-generated sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
In this study the comparisons are between exercise training and no training. Because of the type of training the subjects and therapist will not be blind to group allocation and it is not possible to make a sham treatment for these. The assessor will be blind to group allocation.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2008
Actual
27/01/2009
Date of last participant enrolment
Anticipated
Actual
11/01/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
72
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 3206 0
Charities/Societies/Foundations
Name [1] 3206 0
Workers Compensation Dust Diseases Board of NSW
Country [1] 3206 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Faculty of Health Sciences
C 42
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 2874 0
Hospital
Name [1] 2874 0
Royal Prince Alfred Hospital
Address [1] 2874 0
Department of Respiratory Medicine
E 11 West
Missenden Rd
Camperdown NSW 2050
Country [1] 2874 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5186 0
SSWAHS Ethics Review Committee (RPAH Zone) (EC00113)
Ethics committee address [1] 5186 0
Ethics committee country [1] 5186 0
Australia
Date submitted for ethics approval [1] 5186 0
24/11/2007
Approval date [1] 5186 0
06/12/2007
Ethics approval number [1] 5186 0
X07-0262 and 07/RPAH/145

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

Contacts
Principal investigator
Name 28456 0
Prof Jennifer Alison
Address 28456 0
Faculty of Health Sciences C 42 The University of Sydney NSW 2006
Country 28456 0
Australia
Phone 28456 0
61 2 9351 9371
Fax 28456 0
Email 28456 0
[email protected]
Contact person for public queries
Name 11613 0
Dr Jennifer Alison
Address 11613 0
Faculty of Health Sciences
C 42
The University of Sydney
NSW 2006
Country 11613 0
Australia
Phone 11613 0
61 2 9351 9371
Fax 11613 0
Email 11613 0
[email protected]
Contact person for scientific queries
Name 2541 0
Dr Zoe McKeough
Address 2541 0
Faculty of Health Sciences
C 42
The University of Sydney
NSW 2006
Country 2541 0
Australia
Phone 2541 0
61 2 9351 9269
Fax 2541 0
Email 2541 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
SourceTitleYear of PublicationDOI
EmbaseExercise training for asbestos-related and other dust-related respiratory diseases: A randomised controlled trial.2014https://dx.doi.org/10.1186/1471-2466-14-180
EmbasePhysical activity in people with asbestos related pleural disease and dust-related interstitial lung disease.2015https://dx.doi.org/10.1177/1479972315587518
N.B. These documents automatically identified may not have been verified by the study sponsor.