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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
Update:
Reason:
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?
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Secondary ID:
UTN:
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Trial acronym:
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Page 2
Health condition(s) or problem(s) studied:
soreness, injury
Condition category:
Condition code:
Musculoskeletal
Other muscular and skeletal disorders
Page 3
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
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Reason:
Intervention code:
Prevention
Comparator / control treatment:
no stretching of back or leg muscles
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Control group:
Active
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Page 4
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)
Page 5
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
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Reason:
Minimum Age:
18
Years
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Maximum Age:
No limit
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Gender:
Both males and females
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Healthy volunteers?
Yes
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Key exclusion criteria:
has a lower limb or back injury that restricts participation in vigorous physical activity
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Reason:
Page 6
Study type:
Interventional
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Purpose of the study:
Prevention
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Allocation to intervention:
Randomised controlled trial
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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.
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation):
Simple (unrestricted) randomisation by computer
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Reason:
Masking / blinding:
Open (masking not used)
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Reason:
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Assignment:
Parallel
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Other design features (specify):
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Type of endpoint(s):
Efficacy
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Page 7
Phase
Phase 3
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Reason:
Anticipated or actual date of first participant enrolement:
21/01/2008
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Target sample size:
2388
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Recruitment status:
Closed: follow-up complete
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Page 8
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
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Reason:
Name:
Nasjonalt Kunnskapssenter for Helsetjenesten
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Address:
Postboks 7004 St. Olavsplass, 0031 Oslo
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Reason:
Country:
Norway
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Reason:
Secondary sponsor:
University
Name:
University of Sydney
Address:
The University of Sydney NSW 2006
Country:
Australia
Other collaborator:
Page 9
Has the study received approval from at least one ethics committee?
Yes
Update:
Reason:
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
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Trial website:
English: http://www.stretchingstudy.nokc.no/ Norwegian http://www.toyningsstudien.nokc.no/
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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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Page 10
Contact person for public queries
Name:
Dr Rob Herbert
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Reason:
Address:
The George Institute for International Health
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Reason:
Country:
Australia
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Tel:
none
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Fax:
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Reason:
Email:
stretch@health.usyd.edu.au
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Reason:
Contact person for scientific queries
Name:
Dr Rob Herbert
Update:
Reason:
Address:
The George Institute for International Health
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Reason:
Country:
Australia
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Tel:
none
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Fax:
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Email:
stretch@health.usyd.edu.au
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Reason:
Contact person responsible for updating information
Name:
Dr Rob Herbert
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Reason:
Address:
The George Institute for International Health
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Reason:
Country:
Australia
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Tel:
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Fax:
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Email:
rherbert@george.org.au
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Reason:
