Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000248066
Ethics application status
Approved
Date submitted
15/03/2010
Date registered
24/03/2010
Date last updated
10/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of an exercise program on total daily energy expenditure
Scientific title
For insufficiently active adults aged between 18 and 60 years, does participating in the 40-day physical activity program extensive exercise group compared to the 40-day physical activity program moderate exercise group or no intervention have an effect on energy expenditure, physical activity patterns or resting metabolic rate?
Secondary ID [1] 1537 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
insufficiently active adults 256958 0
Condition category
Condition code
Public Health 257101 257101 0 0
Other public health
Physical Medicine / Rehabilitation 257176 257176 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group A: 40-day physical activity program extensive exercise group (method: 3x60min monitored group sessions and 4x30min self directed sessions per week, duration: 40 days, mode of administration: half monitored group sessions, half self-directed).

Group B: 40-day physical activity program moderate exercise group (method: 3x60min monitored group sessions per fortnight, 2x30min self directed sessions per week, duration: 40 days, mode of administration: half monitored group sessions, half self-directed)

The type of exercises completed in group A and B will involve a range of activities, which may include walking, aerobic circuits, core stability and flexibility sessions, sports, beach activities, swimming, dancing and kite-surfing. The difference between group A and B is how often these activities are completed.
Intervention code [1] 256135 0
Lifestyle
Comparator / control treatment
Group C: receives no exercise intervention
Control group
Active

Outcomes
Primary outcome [1] 257994 0
daily minutes of physical activity [measured by the Multimedia Activity Recall for Children and Adults (MARCA)]
Timepoint [1] 257994 0
baseline, 3 weeks, 40 days, 3 and 6 months
Primary outcome [2] 257995 0
daily accelerometer counts (measured by accelerometers)
Timepoint [2] 257995 0
baseline, 3 weeks, 40 days, 3 and 6 months
Primary outcome [3] 257996 0
daily energy expenditure (measured by the MARCA and doubly-labeled water)
Timepoint [3] 257996 0
baseline, 3 weeks, 40 days, 3 and 6 months
Secondary outcome [1] 263550 0
Nil
Timepoint [1] 263550 0
Nil

Eligibility
Key inclusion criteria
Participants must be ‘insufficiently active’ according to the Active Australia criteria. Insufficiently active means that the person does not achieve 150 minutes of physical activity per week.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded from the study if they are not willing to (a) wear an accelerometer daily for seven days at each measurement period and (b) participate in either the moderate exercise intervention or extensive exercise intervention 40-day group PA program, or (c) act as controls.

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)
Allocation is concealed - central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by computer-generated random number sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2010
Actual
11/01/2011
Date of last participant enrolment
Anticipated
Actual
4/08/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2623 0
5000
Recruitment postcode(s) [2] 2624 0
5001
Recruitment postcode(s) [3] 2625 0
5072
Recruitment postcode(s) [4] 2626 0
5095

Funding & Sponsors
Funding source category [1] 256650 0
Government body
Name [1] 256650 0
National Health and Medical Research Council
Country [1] 256650 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
School of Health Sciences
University of South Australia
GPO Box 2471
Adelaide, South Australia 5001
Country
Australia
Secondary sponsor category [1] 255938 0
Individual
Name [1] 255938 0
Professor Tim Olds
Address [1] 255938 0
School of Health Sciences
University of South Australia
GPO Box 2471
Adelaide, South Australia 5001
Country [1] 255938 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258674 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 258674 0
Research and Innovation Services
University of South Australia
Mawson Lakes Campus
Mawson Lakes Boulevard
Mawson Lakes SA 5095
Ethics committee country [1] 258674 0
Australia
Date submitted for ethics approval [1] 258674 0
01/02/2010
Approval date [1] 258674 0
Ethics approval number [1] 258674 0
P009/10

Summary
Brief summary
The University of South Australia is conducting a research project looking at the effects of a physical activity program on adults aged between 18 and 60 years who exercise for less than two and a half hours each week. This study is interested in finding out how people change their daily activity patterns and energy expenditure when they are involved in a structured exercise program.’
Trial website
Trial related presentations / publications
Gomersall S, Rowlands A, English C, Maher C & Olds T (2012). The activity stat hypothesis- the concept, the evidence and the methodologies. Sports Med, 43(2):135-49.

Gomersall S, Maher C, Norton K, Dollman J, Tomkinson G, Esterman A, English C, Lewis N & Olds T. (2012). Testing the activitystat hypothesis: a randomised controlled trial protocol. BMC Public Health, 12:851.
Public notes

Contacts
Principal investigator
Name 30924 0
Prof Tim Olds
Address 30924 0
University of South Australia
GPO Box 2471
Adelaide
SA 5001
Country 30924 0
Australia
Phone 30924 0
+61 8 8302 1411
Fax 30924 0
Email 30924 0
[email protected]
Contact person for public queries
Name 14171 0
Emily Vaughton
Address 14171 0
School of Health Sciences
University of South Australia
GPO Box 2471
Adelaide, South Australia 5001
Country 14171 0
Australia
Phone 14171 0
+61 8 8302 6558
Fax 14171 0
+61 8 8302 6558
Email 14171 0
[email protected]
Contact person for scientific queries
Name 5099 0
Professor Tim Olds
Address 5099 0
School of Health Sciences
University of South Australia
GPO Box 2471
Adelaide, South Australia 5001
Country 5099 0
Australia
Phone 5099 0
+61 8 8302 1411
Fax 5099 0
+61 8 8302 6558
Email 5099 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
EmbaseTime regained: When people stop a physical activity program, how does their time use change? A randomised controlled trial.2015https://dx.doi.org/10.1371/journal.pone.0126665
N.B. These documents automatically identified may not have been verified by the study sponsor.