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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
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

Study type
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
Comparator / control treatment
No control group
Control group

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

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
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
previous myocardial infarction, previous stroke, hypertrophic cardiomyopathy, heart failure that is not compensated, aortic stenosis

Study design
Purpose of the study
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
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 7336 0
New Zealand
State/province [1] 7336 0

Funding & Sponsors
Funding source category [1] 292405 0
Name [1] 292405 0
National Heart Foundation of New Zealand
Address [1] 292405 0
PO Box 17-160 Greenlane, Auckland 1546
Country [1] 292405 0
New Zealand
Primary sponsor type
Commercial sector/Industry
The Cardiac Clinic
103 Third Ave
New Zealand
Secondary sponsor category [1] 291088 0
Name [1] 291088 0
Address [1] 291088 0
Country [1] 291088 0

Ethics approval
Ethics application status
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
Approval date [1] 293872 0
Ethics approval number [1] 293872 0

Brief summary
Cardiovascular disease remains the leading cause of premature death and disability for all New Zealander’s. Maori, the indigenous people of New Zealand, are disproportionately affected and cardiovascular disease is the principle reason for the difference in life expectancy between Maori and non-Maori in New Zealand. Innovative approaches, focusing on prevention and management of CVD and using principles associated with a Maori worldview, are required to improve CVD health outcomes and life expectancy for Maori. The purpose was to trial a kaupapa Maori approach within an existing 12-week clinical exercise and lifestyle management programme. The aims of the project were to determine the effectiveness of a 12-week exercise and lifestyle management programme, imbedded with a kaupapa Maori philosophy, on cardiovascular disease risk factors and quality of life.
Trial website
Trial related presentations / publications
Public notes

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

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary