Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001269527
Ethics application status
Approved
Date submitted
18/11/2015
Date registered
20/11/2015
Date last updated
20/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of a 12-week exercise and lifestyle management programme on cardiac risk reduction: A pilot using a kaupapa Maori philosophy
Scientific title
The effect of a 12-week exercise and lifestyle management programme on cardiac risk reduction in Maori adults with cardiac risk factors: A pilot using a kaupapa Maori philosophy
Secondary ID [1] 287929 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cardiovascular disease 296805 0
Condition category
Condition code
Cardiovascular 297034 297034 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12-week exercise and lifestyle management
3 x sessions per week for 12 weeks of exercise. Week 1 through 6 is an aerobic only programme, weeks 7 - 12 are a combined aerobic and resistance training programme. sessions range in duration from a minimum of 20min to a maximum of 50mins dependent on each individuals capacity determined during the baseline assessment and as they progress through the 12 weeks. Intensity is based on an RPE on the borg scale between 13 and 16. Sessions are individually prescribed but participants attend as a group. All exercise sessions are supervised by a clinical exercise physiologist and participants are monitored before, during and 5min post exercise [heart rate, blood pressure, oxygen saturation].
6 education sessions on topics decided by the participants that they feel is relevant to their health. Sessions are 1 hour in duration and occur at fortnightly intervals facilitated in a classroom setting in most cases by appropriately qualified and experienced individuals from the community. A register of attendance records adherence.
The overarching kaupapa Maori philosophy pervades all aspects of the project from methodological development, tool critique, results interpretation and dissemination. The project is lead by a Maori PI, with a Maori research assistant and Maori participants
Intervention code [1] 293277 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296631 0
HDL Cholesterol - capillary blood sample with point of care device
Timepoint [1] 296631 0
post 12-week intervention
Primary outcome [2] 296632 0
Waist circumference - measured by lufkin tape during assessment
Timepoint [2] 296632 0
post 12-week intervention
Primary outcome [3] 296633 0
Systolic blood pressure - by sphygmomanometer
Timepoint [3] 296633 0
post 12-week intervention
Secondary outcome [1] 318955 0
Body weight - by digital scales during assessment
Timepoint [1] 318955 0
post 12-week intervention
Secondary outcome [2] 318990 0
Quality of life - measured by unvalidated questionnaire developed using SF-36 and WHOQOL-BREF as guides
Timepoint [2] 318990 0
post 12 week programme

Eligibility
Key inclusion criteria
Maori, 18yrs and over, with more than 2 cardiac risk factors (diabetes, cigarette smoker, hypertension, hypercholesterolemia, less than 30mins physical activity daily, family history of CVD in 1st degree relative, male gender)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
previous myocardial infarction, previous stroke, hypertrophic cardiomyopathy, heart failure that is not compensated, aortic stenosis

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/02/2012
Date of last participant enrolment
Anticipated
Actual
1/03/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
9
Recruitment outside Australia
Country [1] 7336 0
New Zealand
State/province [1] 7336 0

Funding & Sponsors
Funding source category [1] 292405 0
Charities/Societies/Foundations
Name [1] 292405 0
National Heart Foundation of New Zealand
Country [1] 292405 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
The Cardiac Clinic
Address
103 Third Ave
Tauranga
3110
Country
New Zealand
Secondary sponsor category [1] 291088 0
None
Name [1] 291088 0
Address [1] 291088 0
Country [1] 291088 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293872 0
Northern Y Ethics Committee
Ethics committee address [1] 293872 0
Ethics committee country [1] 293872 0
New Zealand
Date submitted for ethics approval [1] 293872 0
10/10/2011
Approval date [1] 293872 0
14/12/2011
Ethics approval number [1] 293872 0
NTY/11/11/107

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

Contacts
Principal investigator
Name 61630 0
Dr Anna Rolleston
Address 61630 0
The Cardiac Clinic
PO Box 13068
Tauranga
3141
Country 61630 0
New Zealand
Phone 61630 0
+64 21 2712152
Fax 61630 0
Email 61630 0
[email protected]
Contact person for public queries
Name 61631 0
Anna Rolleston
Address 61631 0
The Cardiac Clinic
PO Box 13068
Tauranga
3141
Country 61631 0
New Zealand
Phone 61631 0
+64 21 2712152
Fax 61631 0
Email 61631 0
[email protected]
Contact person for scientific queries
Name 61632 0
Anna Rolleston
Address 61632 0
The Cardiac Clinic
PO Box 13068
Tauranga
3141
Country 61632 0
New Zealand
Phone 61632 0
+64 21 2712152
Fax 61632 0
Email 61632 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.