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ANZCTR Newsletter Issue 5, Dec 2009 National and multinational prospective trial registers - The Lancet commentary En route to international clinical trial transparency - The Lancet commentary Declaration of Helsinki now has trial registration requirement (paragraph 19) The 2007 National Health and Medical Research Council (NHMRC) revised National Statement on Ethical Conduct in Human Research includes clause regarding trial registration (page 36, section 3.3.12) The 2007 NHMRC Australian Code for the Responsible Conduct of Research includes a clause regarding trial registration (section 4.10). This Code applies to all NHMRC funded trials The National Ethics Application Form (NEAF) now includes a question regarding details of trial registration (Question 9.1.8.4) ICMJE expands scope of registration ANZCTR is one of the first Primary Registers in the WHO Register Network (Search Portal)
ANZCTR User Survey ANZCTR Statistics International Committee of Medical Journal Editors (ICMJE): June 2007 editorial International Committee of Medical Journal Editors (ICMJE): May 2005 editorial WHO International Clinical Trials Registry Platform (ICTRP) The World Health Organization announces new standards for registration of all human medical research WHO trial registration data set NHMRC Clinical Trials Centre National Health and Medical Research Council (NHMRC) information about the ANZCTR Frequently Asked Questions about the ANZCTR About the ANZCTR How to register a trial How to update a trial

Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
 
Request Number: 082520
ACTR Number: ACTRN12608000044325
Trial Status: Registered
Date Submitted: 11/01/2008
Date Registered: 29/01/2008

Page 1

Public title: A randomised trial of stretching before and after physical activity to prevent soreness and reduce risk of injury
ANZCTR registration 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: 
UTN:
Trial acronym:

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

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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:Prevention 
Comparator / control treatment: no stretching of back or leg muscles
Control group: Active

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

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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
Gender: Both males and females
Healthy volunteers? Yes
Key exclusion criteria: has a lower limb or back injury that restricts participation in vigorous physical activity

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Study type: Interventional
Purpose of the study: Prevention
Allocation to intervention: Randomised controlled trial
Describe the 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.
Describe the 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)
Assignment: Parallel
Other design features (specify):
Type of endpoint(s): Efficacy

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Phase Phase 3
Anticipated or actual start date: 21/01/2008
Target sample size: 2388
Recruitment status: Closed: follow-up complete

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Funding source:Government funding body e.g. Australian Research Council 
Name:New South Wales Sporting Injuries Commission 
Address:95-100 Donnison St Gosford NSW 2250 
Country:Australia 
Primary sponsor: Government funding body e.g. Department of Health
Name: Nasjonalt Kunnskapssenter for Helsetjenesten
Address: Postboks 7004 St. Olavsplass, 0031 Oslo
Country: Norway
Secondary sponsor:University 
Name:University of Sydney 
Address:The University of Sydney NSW 2006 
Country:Australia 
Other collaborator: 

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Has the study received approval from at least one ethics committee? Yes
Ethics Committee name:University of Sydney Human Research Ethics Committee 
Address:The University of Sydney NSW 2006 
Country:Australia 
Date of approval:19/12/2006 
HREC Number:12-2006/9535 
Countries of recruitment:Australia 
Postcode:The trial is internet-based and open to the whole world of English and Norwegian speakers 
Outside Australia 
Afghanistan 
Albania 
Algeria 
American Samoa 
Andorra 
Angola 
Anguilla 
Antarctica 
Antigua and Barbuda 
Argentina 
Brief summary: The primary objectives of this trial are to determine if a program of stretching before and after vigorous physical activity reduces risk of experiencing soreness after physical activity or reduces the risk of incurring an injury while participating in vigorous physical activity
Trial website: English: http://www.stretchingstudy.nokc.no/ Norwegian http://www.toyningsstudien.nokc.no/
Presentations / publication list: Jamtvedt G, Herbert RD, Flottorp S, Odgaard-Jensen J, Håvelsrud K, Barratt A, Mathieu E, Burls A, Oxman AD (in press, accepted 29 May 2009). A pragmatic randomised trial of stretching before and after physical activity to prevent injury and soreness. British Journal of Sports Medicine.

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Contact person for public queries
Name: Dr Rob Herbert
Address: The George Institute for International Health
Country: Australia
Tel: none
Fax:
Email: stretch@health.usyd.edu.au

Contact person for scientific queries
Name: Dr Rob Herbert
Address: The George Institute for International Health
Country: Australia
Tel: none
Fax:
Email: stretch@health.usyd.edu.au

Contact person responsible for updating information
Name: Dr Rob Herbert
Address: The George Institute for International Health
Country: Australia
Tel:
Fax:
Email: rherbert@george.org.au
   
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