Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000595314
Ethics application status
Approved
Date submitted
22/09/2008
Date registered
1/12/2008
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot project for a randomised controlled trial of exercise coaching for general practice patients.
Scientific title
Adults who are insufficiently active, referred by general practitioners to exercise physiologists for 5 visits will become more active than those referred for one visit, as measured by step counts.
Universal Trial Number (UTN)
Trial acronym
COACH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insufficient physical activity. 3733 0
Condition category
Condition code
Physical Medicine / Rehabilitation 3903 3903 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Coaching by exercise physiologist for 5 visits of 40 minutes over 3 months, including fitness assessment and an individually negotiated and written exercise plan.
Intervention code [1] 3445 0
Lifestyle
Comparator / control treatment
Coaching by exercise physiologist for 1 visit of 40 minutes as for the intervention group, but follow up contacts are by telephone, up to 8 calls of 15 minutes over a period of 3 months to check progress, offer support and help solve problems.
Control group
Active

Outcomes
Primary outcome [1] 4802 0
Step counts as measured by sealed pedometers for 7 days.
Timepoint [1] 4802 0
Baseline and 3 months
Secondary outcome [1] 8107 0
Active Australia survey, which measures self reported physical activity over the preceeding 4 weeks..
Timepoint [1] 8107 0
baseline and 3 months

Eligibility
Key inclusion criteria
Adults, less than 8000 steps per day.
Minimum age
20 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Terminally ill.
Unable to give consent.

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)
After measurement of step count by the GP, and consent, randomisation is by offsite research staff after receipt of consent forms by mail.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random numbers from Excel which is a computer program that runs on electricity.
Masking / blinding
Open (masking not 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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3911 0
University
Name [1] 3911 0
University of Newcastle
University St
Country [1] 3911 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Street
Callaghan, NSW 2308
Country
Australia
Secondary sponsor category [1] 3508 0
None
Name [1] 3508 0
Address [1] 3508 0
Country [1] 3508 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6077 0
Human research ethics committee, University of Newcastle
Ethics committee address [1] 6077 0
Ethics committee country [1] 6077 0
Australia
Date submitted for ethics approval [1] 6077 0
31/07/2008
Approval date [1] 6077 0
13/08/2008
Ethics approval number [1] 6077 0
H-2008-0263

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

Contacts
Principal investigator
Name 28964 0
Address 28964 0
Country 28964 0
Phone 28964 0
Fax 28964 0
Email 28964 0
Contact person for public queries
Name 12121 0
Dr Ben Ewald
Address 12121 0
University of Newcastle
University St
Callaghan
NSW 2308
Country 12121 0
Australia
Phone 12121 0
02 49 138 405
Fax 12121 0
Email 12121 0
ben.ewald@newcastle.edu.au
Contact person for scientific queries
Name 3049 0
Dr Ben Ewald
Address 3049 0
University of Newcastle
University St
Callaghan
NSW 2308
Country 3049 0
Australia
Phone 3049 0
02 49 138 405
Fax 3049 0
Email 3049 0
ben.ewald@newcastle.edu.au

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.