Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000281695
Ethics application status
Approved
Date submitted
31/08/2005
Date registered
2/09/2005
Date last updated
2/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does a six-week stretching program change the extensibility of the hamstring muscle ?
Scientific title
Does a six-week stretching program change the extensibility of the hamstring muscle ?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hamstring extensibility 369 0
Condition category
Condition code
Musculoskeletal 434 434 0 0
Normal musculoskeletal and cartilage development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
6 week stretching intervention
Intervention code [1] 315 0
None
Comparator / control treatment
Control
Control group
Placebo

Outcomes
Primary outcome [1] 495 0
Bilateral torque controlled hamstring extensibility
Timepoint [1] 495 0
Secondary outcome [1] 1064 0
Bilateral hamstring stretch tolerance.
Timepoint [1] 1064 0

Eligibility
Key inclusion criteria
Any able-bodied individual able to tolerate hamstring stretches Must be able to attend supervised stretch sessions
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
concealed allocation using opaque, sequentially numbered envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random allocation sequence was done using a computer program (random computer number generator function in Excel). No restriction was used for the randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
mixed with-in and between subject design
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 484 0
Self funded/Unfunded
Name [1] 484 0
Country [1] 484 0
Primary sponsor type
University
Name
University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 391 0
Charities/Societies/Foundations
Name [1] 391 0
Royal Rehabilitation Centre Sydney
Address [1] 391 0
Country [1] 391 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1463 0
University of Sydney
Ethics committee address [1] 1463 0
Ethics committee country [1] 1463 0
Australia
Date submitted for ethics approval [1] 1463 0
Approval date [1] 1463 0
Ethics approval number [1] 1463 0
Ethics committee name [2] 1464 0
Royal Rehabilitation Centre Sydney
Ethics committee address [2] 1464 0
Ethics committee country [2] 1464 0
Australia
Date submitted for ethics approval [2] 1464 0
Approval date [2] 1464 0
Ethics approval number [2] 1464 0

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

Contacts
Principal investigator
Name 36109 0
Address 36109 0
Country 36109 0
Phone 36109 0
Fax 36109 0
Email 36109 0
Contact person for public queries
Name 9504 0
Marsha Ben
Address 9504 0
Royal Rehabilitation Centre Sydney
600 Victoria Road
Ryde NSW 2112
Country 9504 0
Australia
Phone 9504 0
+61 2 98089269
Fax 9504 0
Email 9504 0
benm@doh.health.nsw.gov.au
Contact person for scientific queries
Name 432 0
Marsha Ben
Address 432 0
Royal Rehabilitation Centre Sydney
600 Victoria Road
Ryde NSW 2112
Country 432 0
Australia
Phone 432 0
+61 2 98089269
Fax 432 0
Email 432 0
benm@doh.health.nsw.gov.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.