Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000044325
Ethics application status
Approved
Date submitted
11/01/2008
Date registered
29/01/2008
Date last updated
2/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised trial of stretching before and after physical activity to prevent soreness and reduce risk of injury
Scientific title
Does stretching before and after physical activity prevent soreness and reduce risk of injury more than no stretching in people who do recreational exercise?
Secondary ID [1] 260103 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
soreness, injury 2702 0
Condition category
Condition code
Musculoskeletal 2822 2822 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
stretching of back and leg muscles (7 muscle groups, both sides, 30 seconds) before and after exercise for a 12 week period
Intervention code [1] 2439 0
Prevention
Comparator / control treatment
no stretching of back or leg muscles
Control group
Active

Outcomes
Primary outcome [1] 3706 0
muscle soreness
Timepoint [1] 3706 0
longitudinal design (soreness is evaluated weekly for 12 weeks)
Primary outcome [2] 3770 0
injury
Timepoint [2] 3770 0
survival analysis of times to injuries observed in a 12 week monitoring period
Secondary outcome [1] 6368 0
severity of soreness (11-point scale)
Timepoint [1] 6368 0
longitudinal design (soreness is evaluated weekly for 12 weeks)
Secondary outcome [2] 6369 0
injuries for which medical attention is sought
Timepoint [2] 6369 0
survival analysis of times to injuries observed in a 12 week monitoring
Secondary outcome [3] 6370 0
injuries that might be prevented by stretching
Timepoint [3] 6370 0
survival analysis of times to injuries observed in a 12 week monitoring period
Secondary outcome [4] 6371 0
perception of "looseness" during and after exercise (11-point scale)
Timepoint [4] 6371 0
longitudinal design (looseness is evaluated weekly for 12 weeks)

Eligibility
Key inclusion criteria
1. aged 18 years or over.
2. able to read and write in English or Norwegian.
3. takes part in vigorous physical activity on at least one day in the past week
4. regularly accesses internet and email
5. willing to stop stretching (if currently stretching) or begin stretching (if currently not stretching) before and after exercise
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
has a lower limb or back injury that restricts participation in vigorous physical activity

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)
Participants visit the trial web site and answer screening questions. If they are eligible and consent they are randomised online.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple (unrestricted) randomisation by computer
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2388
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 544 0
The trial is internet-based and open to the whole world of English and Norwegian speakers

Funding & Sponsors
Funding source category [1] 2955 0
Government body
Name [1] 2955 0
New South Wales Sporting Injuries Commission
Country [1] 2955 0
Australia
Primary sponsor type
Government body
Name
Nasjonalt Kunnskapssenter for Helsetjenesten
Address
Postboks 7004 St. Olavsplass, 0031 Oslo
Country
Norway
Secondary sponsor category [1] 2668 0
University
Name [1] 2668 0
University of Sydney
Address [1] 2668 0
The University of Sydney NSW 2006
Country [1] 2668 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4896 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 4896 0
Ethics committee country [1] 4896 0
Australia
Date submitted for ethics approval [1] 4896 0
Approval date [1] 4896 0
19/12/2006
Ethics approval number [1] 4896 0
12-2006/9535

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

Contacts
Principal investigator
Name 28289 0
Address 28289 0
Country 28289 0
Phone 28289 0
Fax 28289 0
Email 28289 0
Contact person for public queries
Name 11446 0
Dr Rob Herbert
Address 11446 0
The George Institute for International Health
Country 11446 0
Australia
Phone 11446 0
none
Fax 11446 0
Email 11446 0
[email protected]
Contact person for scientific queries
Name 2374 0
Dr Rob Herbert
Address 2374 0
The George Institute for International Health
Country 2374 0
Australia
Phone 2374 0
none
Fax 2374 0
Email 2374 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.