Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001276943
Ethics application status
Approved
Date submitted
5/12/2011
Date registered
13/12/2011
Date last updated
18/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Quantitative analysis of posture in patients with breast cancer related to actions of nursing and physiotherapy
Scientific title
Quantitative analysis of posture in patients with breast cancer related to actions of nursing and physiotherapy
Secondary ID [1] 273598 0
does not apply
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast cancer 279060 0
Condition category
Condition code
Cancer 279252 279252 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patients who attend a support center for women with breast cancer will be photographed immediately after surgery for tumor removal. The photographs will be repeated following the same standardization month after month until the end of the sixth month.In the first evaluation, patients will respond using a questionnaire semi-structured on the interventions of nursing in the periods before, during and after surgery. Receive guidance on basic nursing care and conduct weekly group exercises during six month. The exercises are carried out once a week for 1 hour under the supervision of a physiotherapist. These sessions involve exercises to improve shoulder range of motion, stretching exercises for upper and lower limbs and spine and circulatory exercises physiotherapist. The photographs will be analyzed by a computer program for analysis of postural changes and the postural changes will be quantified
Intervention code [1] 283641 0
Rehabilitation
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 279874 0
To compare the posture of women who have had surgery to remove a breast tumor
Timepoint [1] 279874 0
Immediately after surgery and monthly until the sixth month after surgery
Secondary outcome [1] 294652 0
To compare the range of motion in the arms of women who have had surgery to remove a breast tumor using photogrammetry
Timepoint [1] 294652 0
Immediately after surgery and monthly until the sixth month after surgery using photogrammetry

Eligibility
Key inclusion criteria
Women who participate in the support center for women with breast cancer the Federal University of Alfenas in 2011-2012, which have recently undergone surgery to remove the tumor in the breast
Minimum age
30 Years
Maximum age
70 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Women who do not agree to participate. Women who are already doing exercises support center for women with breast cancer the Federal University of Alfenas in the last year

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
To participate in the study were considered all women who start the treatment at the Department of Education, Research and Extension Women and breast cancer during this study
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
single group
Masking / blinding
Open (masking not used)
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
30/08/2010
Actual
31/08/2010
Date of last participant enrolment
Anticipated
Actual
6/02/2014
Date of last data collection
Anticipated
Actual
14/08/2014
Sample size
Target
20
Accrual to date
Final
17
Recruitment outside Australia
Country [1] 3935 0
Brazil
State/province [1] 3935 0
Minas Gerais

Funding & Sponsors
Funding source category [1] 284120 0
University
Name [1] 284120 0
Federal University of Alfenas
Country [1] 284120 0
Brazil
Primary sponsor type
University
Name
Federal University of Alfenas
Address
700 Gabriel Monteiro da Silva, street
Downtown
Alfenas - Minas Gerais
37130-000
Country
Brazil
Secondary sponsor category [1] 283305 0
None
Name [1] 283305 0
Address [1] 283305 0
Country [1] 283305 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 272081 0
Ethics Committee name:Ethics and Research of the Federal university of Alfenas
Ethics committee address [1] 272081 0
Ethics committee country [1] 272081 0
Brazil
Date submitted for ethics approval [1] 272081 0
Approval date [1] 272081 0
13/08/2010
Ethics approval number [1] 272081 0
048/2010
Ethics committee name [2] 301001 0
Ethics Committee name:Ethics and Research of the Federal University of Alfenas
Ethics committee address [2] 301001 0
Ethics committee country [2] 301001 0
Brazil
Date submitted for ethics approval [2] 301001 0
09/04/2010
Approval date [2] 301001 0
13/08/2010
Ethics approval number [2] 301001 0
048/2010

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

Contacts
Principal investigator
Name 33327 0
Dr Denise Hollanda Iunes
Address 33327 0
53, Professor Carvalho Junior, Street Downtown Alfenas- Minas Gerais 37130-000
Country 33327 0
Brazil
Phone 33327 0
55 33 35 32991380
Fax 33327 0
Email 33327 0
[email protected]
Contact person for public queries
Name 16574 0
Denise Hollanda Iunes
Address 16574 0
53, Professor Carvalho Junior, Street
Downtown
Alfenas- Minas Gerais
37130-000
Country 16574 0
Brazil
Phone 16574 0
55 33 35 32991380
Fax 16574 0
55 33 35 32991381
Email 16574 0
[email protected]
Contact person for scientific queries
Name 7502 0
Denise Hollanda Iunes
Address 7502 0
53, Professor Carvalho Junior, Street
Downtown
Alfenas- Minas Gerais
37130-000
Country 7502 0
Brazil
Phone 7502 0
553537011921
Fax 7502 0
55 33 35 32991381
Email 7502 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.