Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000842662
Ethics application status
Approved
Date submitted
28/07/2014
Date registered
7/08/2014
Date last updated
7/08/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Tasmanian Aborigines Step Up to Health: evaluation of a cardiopulmonary rehabilitation and secondary prevention program
Scientific title
Evaluation of participation of Tasmanian Aborigines in a cardiopulmonary rehabilitation program: a comparison of pre and post measures of physical fitness and quality of life
Secondary ID [1] 285010 0
Nil
Universal Trial Number (UTN)
U1111-1159-4578
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic cardiovascular disease 292522 0
Chronic obstructive pulmonary disease 292523 0
Condition category
Condition code
Cardiovascular 292824 292824 0 0
Coronary heart disease
Cardiovascular 292825 292825 0 0
Other cardiovascular diseases
Respiratory 292826 292826 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participation in a 10 week cardiac and pulmonary rehabilitation program run by an Aboriginal community controlled health service. The program was specifically designed for Tasmanian Aborigines by the Aboriginal Health Service using guidelines from the National Heart Foundation and Australian Lung Foundation.
Participant assessments in weeks 1 and 10, with the baseline assessments being used to prescribe an individualised exercise program reviewed and upgraded on a weekly basis. The exercise assessments, supervision and review were done by an exercise physiologist or physiotherapist. Exercise equipment included stationary bikes, steps and weights. The exercise sessions were of one hour duration, twice a week.
The education session were coordinated by an Aboriginal health worker, were held for one hour once per week, and promoted self-management approaches to improving cardiovascular and pulmonary health.
Participation in exercise and education sessions recorded and analysed, along with measures of physical fitness and wellbeing.
Intervention code [1] 289844 0
Rehabilitation
Comparator / control treatment
No comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292690 0
Anthropometry as measured by BMI and waist circumference
Timepoint [1] 292690 0
10 weeks
Primary outcome [2] 292691 0
Physical capacity as measured by 6MWT and ISWT
Timepoint [2] 292691 0
10 weeks
Primary outcome [3] 292692 0
Quality of life as measured by Medical Outcomes Short Form (SF36) and Chronic Respiratory Questionnaire (CRQ)
Timepoint [3] 292692 0
10 weeks
Secondary outcome [1] 309510 0
Participation in rehabilitation as measured by number of exercise and education sessions attended.
Timepoint [1] 309510 0
10 weeks

Eligibility
Key inclusion criteria
Aborigines with established CVD or COPD or at high risk
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unstable CVD

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Clinic or self- referral
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative analysis of participation and rehabilitation outcomes performed on STATA using chi- squared, t-tests and Cohen's d. Qualitative thematic analysis of feedback from staff and participants.
The evaluation was of an ongoing clinical program where the participants were recruited for clinical purposes, rather than for a trial. No sample size estimates were made.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2011
Actual
3/10/2011
Date of last participant enrolment
Anticipated
1/03/2013
Actual
1/03/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 289622 0
Charities/Societies/Foundations
Name [1] 289622 0
Tasmanian Aboriginal Centre
Country [1] 289622 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Tasmanian Aboriginal Centre
Address
56 Patrick St
Hobart
Tasmania
7000
Country
Australia
Secondary sponsor category [1] 288310 0
University
Name [1] 288310 0
Breathe Well, Centre for Research Excellence for Chronic Respiratory Disease and Lung Ageing. University of Tasmania
Address [1] 288310 0
17 Liverpool St, Hobart
Tasmania, 7000
Country [1] 288310 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291364 0
Human Research Ethics Committee, Tasmania
Ethics committee address [1] 291364 0
Ethics committee country [1] 291364 0
Australia
Date submitted for ethics approval [1] 291364 0
Approval date [1] 291364 0
01/08/2011
Ethics approval number [1] 291364 0
H00112041

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

Contacts
Principal investigator
Name 50038 0
Dr Maureen Davey
Address 50038 0
Tasmanian Aboriginal Centre
56 Patrick St
Hobart
Tasmania
7000
Country 50038 0
Australia
Phone 50038 0
61409782541
Fax 50038 0
Email 50038 0
[email protected]
Contact person for public queries
Name 50039 0
Maureen Davey
Address 50039 0
Tasmanian Aboriginal Centre
56 Patrick St
Hobart
Tasmania
7000
Country 50039 0
Australia
Phone 50039 0
61409782541
Fax 50039 0
Email 50039 0
[email protected]
Contact person for scientific queries
Name 50040 0
Maureen Davey
Address 50040 0
Tasmanian Aboriginal Centre
56 Patrick St
Hobart
Tasmania
7000
Country 50040 0
Australia
Phone 50040 0
61409782541
Fax 50040 0
Email 50040 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.