Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000703000
Ethics application status
Approved
Date submitted
11/06/2010
Date registered
25/08/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of a preventive back care program on students level of knowledge
Scientific title
Effects of a preventive back care program on school students' level of knowledge
Secondary ID [1] 251888 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
low back pain 257480 0
postural deviation 257560 0
Condition category
Condition code
Musculoskeletal 257632 257632 0 0
Other muscular and skeletal disorders
Public Health 258090 258090 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
back school children program including lessons on back anatomy and physiology, proper sitting posture, lifting techniques. All lessons were given at school, during the class period and lasted 50 minutes each one. The program was comprised by three sessions aplied by two physiotherapists with one week apart.
Intervention code [1] 256578 0
Prevention
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258542 0
level of theoretical and practical knowledge about back care assessed by questionnaires and practical test simulating real situations of manual material handling
Timepoint [1] 258542 0
imediately after the third and final session intervention
Secondary outcome [1] 264385 0
no sencondary outcome
Timepoint [1] 264385 0
no

Eligibility
Key inclusion criteria
students
Minimum age
9 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
students aged less than 9 years old; students whose parents did not signed the consent form.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
392
Accrual to date
Final
Recruitment outside Australia
Country [1] 2673 0
Brazil
State/province [1] 2673 0
SAO PAULO

Funding & Sponsors
Funding source category [1] 257074 0
University
Name [1] 257074 0
Universidade Federal de Sao Carlos
Country [1] 257074 0
Brazil
Funding source category [2] 257126 0
Government body
Name [2] 257126 0
Conselho Nacional de Desenvolvimento Cientifico Tecnologico (CNPq)
Country [2] 257126 0
Brazil
Primary sponsor type
Individual
Name
Fabiana Almeida Foltran
Address
Rodovia Washington Luiz, km 235
Zip Code: 13565-905 Sao Carlos SP
Country
Brazil
Secondary sponsor category [1] 256332 0
Individual
Name [1] 256332 0
Roberta de Fatima Carreira Moreira
Address [1] 256332 0
Rodovia Washington Luiz, km 235
Zip Code: 13565-905 Sao Carlos SP
Country [1] 256332 0
Brazil
Other collaborator category [1] 1309 0
Individual
Name [1] 1309 0
Mariana Oshida Komatsu
Address [1] 1309 0
Rodovia Washington Luiz, km 235
Zip Code: 13565-905 Sao Carlos SP
Country [1] 1309 0
Brazil
Other collaborator category [2] 1310 0
Individual
Name [2] 1310 0
Mariana Furlan Falconi
Address [2] 1310 0
Rodovia Washington Luiz, km 235
Zip Code: 13565-905 Sao Carlos SP
Country [2] 1310 0
Brazil
Other collaborator category [3] 1311 0
Individual
Name [3] 1311 0
Tatiana de Oliveira Sato
Address [3] 1311 0
Rodovia Washington Luiz, km 235
Zip Code: 13565-905 Sao Carlos SP
Country [3] 1311 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259095 0
Comite de etica e pesquisa em seres humanos da Universidade Federal de Sao Carlos
Ethics committee address [1] 259095 0
Rodovia Washington Luiz, km 235
Zip Code: 13565-905 Sao Carlos SP
Ethics committee country [1] 259095 0
Brazil
Date submitted for ethics approval [1] 259095 0
08/09/2008
Approval date [1] 259095 0
03/04/2009
Ethics approval number [1] 259095 0
0124.0.135.000-08

Summary
Brief summary
to evaluate the effects of back care program on schoolchildren level of knowledge
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31237 0
Address 31237 0
Country 31237 0
Phone 31237 0
Fax 31237 0
Email 31237 0
Contact person for public queries
Name 14484 0
Fabiana Almeida Foltran
Address 14484 0
Rodovia Washington Luiz, km 235
Zip Code: 13565-905 Sao Carlos SP
Country 14484 0
Brazil
Phone 14484 0
551633518634
Fax 14484 0
551633612081
Email 14484 0
fafoltran@gmail.com
Contact person for scientific queries
Name 5412 0
Tatiana de Oliveira Sato
Address 5412 0
Rodovia Washington Luiz, km 235
Zip Code: 13565-905 Sao Carlos SP
Country 5412 0
Brazil
Phone 5412 0
551633519576
Fax 5412 0
551633612081
Email 5412 0
tatisato@gmail.com

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.