Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000003077
Ethics application status
Approved
Date submitted
16/12/2009
Date registered
5/01/2010
Date last updated
29/11/2021
Date data sharing statement initially provided
29/11/2021
Date results provided
29/11/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Health benefits of differing types of exercise in a Pacific community
Scientific title
Randomised controlled trial of informal team sports for cardiorespiratory fitness and health benefit in Pacific adults
Secondary ID [1] 305922 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preventative Health Strategies in Pacific Health 252380 0
Condition category
Condition code
Public Health 256559 256559 0 0
Health promotion/education
Cardiovascular 256560 256560 0 0
Diseases of the vasculature and circulation including the lymphatic system
Metabolic and Endocrine 256561 256561 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following baseline assessments, participants were randomly allocated to intervention or control. (The change from a three arm trial to a two arm trial was made during participant recruitment due to difficulty in recruiting adequate sample size)
The participants in the intervention group were encouraged to attend three training sessions per week over four weeks. The sessions comprised various small-sided games including soccer, basketball, volleyball, touch rugby, cricket and other non-conventional games such as ‘chain tag’, ‘rob the nest’ and ‘bullrush’. Each session lasted 45 minutes and included a 10-minute warm-up period and regular rest periods. The sessions were supervised and conducted by the three sports and exercise postgraduate students. Basic technical advice was given to the participants for safety reasons.
Participants in the control group were offered 4 weeks gym membership at the end of the trial.
Intervention code [1] 255681 0
Lifestyle
Intervention code [2] 255710 0
Prevention
Comparator / control treatment
Usual activity
Control group
Active

Outcomes
Primary outcome [1] 257447 0
cardiovascular fitness as assessed by changes in maximal oxygen uptake (VO2 max)
Timepoint [1] 257447 0
measured at baseline and at 4 weeks
Primary outcome [2] 257448 0
Leg strength assessed by maximal concentric force of the quadriceps and hamstring muscle groups measured at 60 degrees/sec, using biodex measuring equipment.
Timepoint [2] 257448 0
measured at baseline and at 4 weeks
Secondary outcome [1] 262593 0
Fasting glucose and glycated haemoglobin
Timepoint [1] 262593 0
measured at baseline and at 4 weeks, using analysis of a venous blood sample
Secondary outcome [2] 262594 0
Lipid profile (total cholesterol, low-density lipoprotein (LDL), triglycerides, high-density lipoprotein (HDL))
Timepoint [2] 262594 0
measured at baseline and at 4 weeks, using analysis of a fasting venous blood sample
Secondary outcome [3] 262595 0
Systolic and diastolic blood pressure
Timepoint [3] 262595 0
measured at baseline and at 4 weeks using sphygmomanometers
Secondary outcome [4] 262596 0
Inflammatory markers measured by C-reactive protein (CRP)
Timepoint [4] 262596 0
measured at baseline and at 4 weeks, using levels of the inflammatory marker C-reactive protein from analysis of a venous blood sample.
Secondary outcome [5] 262597 0
Psychological well-being (assessed by subjective exercise experiences scale)
Timepoint [5] 262597 0
measured at baseline and at 4 weeks

Eligibility
Key inclusion criteria
Age 16-65 years. - age limited extended during enrolment
Pacific ethnicity.
Participating in fewer than 2 formal exercise sessions per week
Minimum age
16 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participating in at least 2 formal exercise session per week.
Non-Pacific ethnicity.
Pre-existing injuries, physical or mental conditions pre-cluding ability to participate (as assessed by health questionaire)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Informed consent, baseline measures assessed then allocation of randomisation using numbered opaque envelopes. Allocation is concealed at baseline outcome measures
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer randomised sequence by independent researcher
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Two-arm study using electronic monitoring equipment, objective outcome measures and standardised testing procedures to minimise operator bias
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2010
Actual
1/01/2010
Date of last participant enrolment
Anticipated
Actual
1/02/2010
Date of last data collection
Anticipated
Actual
8/03/2010
Sample size
Target
30
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 2360 0
New Zealand
State/province [1] 2360 0

Funding & Sponsors
Funding source category [1] 256160 0
University
Name [1] 256160 0
Auckland University
Country [1] 256160 0
New Zealand
Primary sponsor type
University
Name
Auckland University
Address
University of Auckland
Private Bag 92019
Auckland
Country
New Zealand
Secondary sponsor category [1] 251503 0
None
Name [1] 251503 0
Address [1] 251503 0
Country [1] 251503 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258267 0
University of Auckland Human Participants Ethics Comittee
Ethics committee address [1] 258267 0
Ethics committee country [1] 258267 0
New Zealand
Date submitted for ethics approval [1] 258267 0
Approval date [1] 258267 0
02/12/2009
Ethics approval number [1] 258267 0
2009 / 536

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

Contacts
Principal investigator
Name 30608 0
A/Prof C Raina Elley
Address 30608 0
Dept General Practice and PHC,
University of Auckland,
Private Bag 92019
Auckland 1142
Country 30608 0
New Zealand
Phone 30608 0
+6493737599
Fax 30608 0
Email 30608 0
[email protected]
Contact person for public queries
Name 13855 0
C Raina Elley
Address 13855 0
Dept General Practice and PHC,
University of Auckland,
Private Bag 92019
Auckland 1142
Country 13855 0
New Zealand
Phone 13855 0
+64 9 3737599
Fax 13855 0
Email 13855 0
[email protected]
Contact person for scientific queries
Name 4783 0
Dr Carolyn Raina Elley
Address 4783 0
Department of General Practice and Primary Health Care, School of Population Health
University of Auckland
Private Bag 92019
Auckland
Country 4783 0
New Zealand
Phone 4783 0
+64 9 3737599
Fax 4783 0
Email 4783 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
I don't have the resources to do this


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.