Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000758000
Ethics application status
Approved
Date submitted
16/05/2010
Date registered
14/09/2010
Date last updated
14/09/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of exercises using equipment in conjunction with an arm sleeve compression to reduce the size of lymphedematous in patients after breast cancer
Scientific title
The effect of exercises utilizing apparatus associated with an arm sleeve compression garment on reducing the size of lymphedematous in patients after breast cancer
Secondary ID [1] 251778 0
Null
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Condition: Lymphedema 257374 0
Condiction: Breast Cancer 257385 0
Condition category
Condition code
Physical Medicine / Rehabilitation 257520 257520 0 0
Occupational therapy
Cardiovascular 257521 257521 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cancer 257533 257533 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will examine the effectiveness reduction in the size of lymphedematous arms of patients after breast cancer with a difference in volume of 200 mL between arm compared with the normal arm, diagnostic criterion(clinical) for lymphedema ,utilizing a facilitating exercising device associated with a compression arm sleeve. The compression used is made national material -polyester and cotton, low elasticity (>15mmHg) involving whole member (arm and forearm), put immediately prior to activity. The patients will submitted to a single one-hour session of active exercises, while sitting with the spinal column erect, of four 12-minute stints with intervals of three minutes to rest. Evaluation was achieved by water volumetry before and immediately after the session. The active exercising device is similar to the pedaling system of a bicycle that utilizes both upper limbs. This apparatus is fixed on a table at a height of 30 cm with the table at a distance of 10 cm from the patient's body.
Intervention code [1] 256481 0
Rehabilitation
Intervention code [2] 256491 0
Treatment: Devices
Comparator / control treatment
No have control group, the control is upper limb healthy(volume).
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258435 0
Reduction in the volume of the lymphedematous arms of patients utilizing a facilitating exercising device associated with a compression arm sleeve after one hour the activity. Evaluation will achieved by water volumetry before and immediately after the session.The volume of lymphedematous arm and healthy upper arm will be evaluated initial and after activity to compare the reduction (control).
Timepoint [1] 258435 0
Funcional evaluation: The primary outcome is to evaluate the volume inicial the limbs for volumetry before beginning the proposed activity and assess immediately after an hour of activity.
Secondary outcome [1] 264218 0
Nill
Timepoint [1] 264218 0
Nill

Eligibility
Key inclusion criteria
Lymphedema patients after breast cancer
Patients undergoing treatment will require written permission from their physician
Without active infection and skin lesion
Patients must sign a consent form to participate
Minimum age
20 Years
Maximum age
90 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients undergoing treatment without physician's written permission
Patients with active infection and skin lesion

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)
Nill
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Nill
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 2629 0
Brazil
State/province [1] 2629 0

Funding & Sponsors
Funding source category [1] 256972 0
Government body
Name [1] 256972 0
CAPES-Coordination of Improvement of Personal of Superior Level -Brazil
Country [1] 256972 0
Brazil
Primary sponsor type
Government body
Name
CAPES-Coordination of Improvement of Personal of Superior Level -Brazil
Address
Setor Bancario Norte, Quadra 2, Bloco L, Lote 06, CEP 70040-020 - Brasilia, DF
Brazil
Country
Brazil
Secondary sponsor category [1] 256233 0
None
Name [1] 256233 0
Address [1] 256233 0
Country [1] 256233 0
Other collaborator category [1] 251490 0
University
Name [1] 251490 0
Medicine School of Sao Jose do Rio Preto
Address [1] 251490 0
AV Brigadeiro Faria Lima 5416
Sao Jose do Rio Preto-SP-Brazil
CEP:15090-000
Country [1] 251490 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258987 0
Committee Ethics Instituto de Biociencias Letras e Ciencias Exatas, Campus de Sao Jose do Rio Preto - SP
Ethics committee address [1] 258987 0
Rua Cristovao Colombo, 2265
Bairro: Jardim Nazareth
CEP: 15054-000
Sao Jose do Rio Preto - Sao Paulo
Ethics committee country [1] 258987 0
Brazil
Date submitted for ethics approval [1] 258987 0
13/02/2007
Approval date [1] 258987 0
12/03/2007
Ethics approval number [1] 258987 0
1/11/2007

Summary
Brief summary
Aim: The aim of this study will to evaluate the reduction in the size of lymphedematous arms of patients utilizing a facilitating exercising device associated with a compression arm sleeve. Methods: Thirty subjects, suffering from arm lymphedema after surgical, chemotherapeutic and radiotherapeutic treatment for breast cancer. The criterion for starting the assessments will be by finishing order of subjects in a rehabilitation group. The patients were submitted to a one-hour session of active exercises, while sitting with the spinal column erect, of four 12-minute stints with intervals of three minutes to rest. Evaluation will achieved by water volumetry before and immediately after the session. The active exercising device is similar to the pedaling system of a bicycle. The paired t-test will employed for statistical analysis with an alpha error of 5% (p-value < 0.05) being considered acceptable.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31167 0
Address 31167 0
Country 31167 0
Phone 31167 0
Fax 31167 0
Email 31167 0
Contact person for public queries
Name 14414 0
Jose Maria Pereira de Godoy
Address 14414 0
Rua Floriano Peixoto 2950
Sao Jose do Rio Preto-Sao Paulo-Brazil
Zipe code:15020010
Country 14414 0
Brazil
Phone 14414 0
Phone: 55 17 32326362
Fax 14414 0
Email 14414 0
[email protected]
Contact person for scientific queries
Name 5342 0
Maria de Fatima Guerreiro Godoy
Address 5342 0
Rua Floriano Peixoto 2950
Sao Jose do Rio Preto-Sao Paulo-Brazil
Zipe code:15020010
Country 5342 0
Brazil
Phone 5342 0
Phone: 55 17 32326362
Fax 5342 0
Email 5342 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.