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Trial registered on ANZCTR


Registration number
ACTRN12610000763044
Ethics application status
Approved
Date submitted
6/09/2010
Date registered
15/09/2010
Date last updated
15/09/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Synergic effect of compression in the reduction of arm lymphedema during controlled active exercising using a facilitating device
Scientific title
Synergic effect of compression in the reduction of breast cancer related arm lymphedema during controlled active exercising using a facilitating device
Secondary ID [1] 252645 0
Not have secondary ID
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arm lymphedema resulting from breast cancer 258136 0
Condition category
Condition code
Physical Medicine / Rehabilitation 258318 258318 0 0
Occupational therapy
Cancer 258349 258349 0 0
Breast
Cardiovascular 258350 258350 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will examine the effect of compression during active exercising using a facilitating apparatus, on arm lymphedema resulting from breast cancer treatment, with a difference in volume of 200 mL between arms compared with the normal arm, diagnostic criterion (clinical) for lymphedema. The compression used is made national material-polyester and cotton, low elasticity (>15mmHg) involving whole member (arm and forearm). It is put on the arm immediately before starting exercise. The method for performing each step of study with compression and without compression. Will randomly enrolled in the study patients from a rehabilitation group. The apparatus that will used is denominated 'pulley system' and is a vertical iron wheel fixed to a 30 cm-high support on a metal bench placed at a distance of 10 cm from the patient's body. The patient revolves the wheel and thus elevates the shoulder and stretches the arm. The patients will submitted to two series of active exercises separate by a duration of 1 week, using this facilitating device, one session with compression and one session without compression in a random order. The total time for evaluation using compression will be one hour, divided into four intervals of 12 minutes of exercise using the device and three minutes of rest. For activity without compression is the same test time. The patient will remain seated with the spinal column properly aligned.
Intervention code [1] 257154 0
Treatment: Devices
Intervention code [2] 257190 0
Rehabilitation
Comparator / control treatment
The effect of compression and withouth compression during arm active exercising using a facilitating apparatus.
Control group
Active

Outcomes
Primary outcome [1] 259171 0
Reduction in the volume of the lymphedematous arms of patients utilizing a facilitating exercising device associated with a compression. Evaluation will achieved by water volumetry before and immediately after the session.
Timepoint [1] 259171 0
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 with mechanism compression (garments).
Secondary outcome [1] 265515 0
The aim of this study is to reduce the volume in the limbs with lymphedema after exercise, using device facilitator mechanism. In secondary time a proposal the study is the evaluation of that device in this same group of individuals without the use of compression. The evaluated will water volumetry.
Timepoint [1] 265515 0
In secondary time evaluate volume inicial the limbs immediately after an hour of activity without mechanism the compression (garments).

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
21 Years
Maximum age
90 Years
Sex
Both males and 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
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/09/2010
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] 2853 0
Brazil
State/province [1] 2853 0

Funding & Sponsors
Funding source category [1] 257606 0
Government body
Name [1] 257606 0
CAPES-Coordination of Improvement of Personal of Superior Level -Brazil.
Country [1] 257606 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
Country
Brazil
Secondary sponsor category [1] 256831 0
None
Name [1] 256831 0
Address [1] 256831 0
Country [1] 256831 0
Other collaborator category [1] 251484 0
University
Name [1] 251484 0
Medicine School of Sao Jose do Rio Preto
Address [1] 251484 0
Av Brigadeiro Faria Lima, 5416
Sao Jose do Rio Preto-Sao Paulo-Brazil
Cep:15090-000
Country [1] 251484 0
Brazil
Other collaborator category [2] 251491 0
Individual
Name [2] 251491 0
Jose Maria Pereira de Godoy
Address [2] 251491 0
Vascular Laser Center -Clinica Godoy
AV Constituicao 1306-Boa Vista
Sao Jose do Rio Preto-Sao Paulo-Brazil
CEP:15025-120
Country [2] 251491 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259626 0
Instituto de Biociencias Letras e Ciencias Exatas, Campus de Sao Jose do Rio Preto - SP
Ethics committee address [1] 259626 0
Rua Cristovao Colombo, 2265
Bairro: Jardim Nazareth
CEP: 15054-000
Sao Jose do Rio Preto - SP -Brazil
Ethics committee country [1] 259626 0
Brazil
Date submitted for ethics approval [1] 259626 0
Approval date [1] 259626 0
12/03/2007
Ethics approval number [1] 259626 0
number 11- year 2007

Summary
Brief summary
The purposes of the current study will to evaluate the effect of compression during active exercising using a facilitating apparatus, on arm lymphedema resulting from breast cancer treatment. 30 Subjects with edema of the arm resulting in a difference in volume of more than 200 mL compared to the contralateral arm . An apparatus denominated 'pulley system' will utilized. The participants, in the seated position with the spinal column properly aligned, submitted to two series of four 12-minute sessions (separated by 3-minute intervals to rest giving a total of one hour) of active exercises using this facilitating apparatus. A compression garment, made of a cotton-polyester material, will used on the lymphedematous limb for one of the series of exercising sessions but for the other series no compression will used. Volumetry by water displacement will performed before and after each series of exercises in lymphedematous and healthy limbs. The displaced water will weighed on calibrated weighing scales. The paired t-test will employ for statistical analysis with an alpha error of 5% (p-value < 0.05) being considered acceptable. The expected for clinical practice is that the association with the mechanism of restraint device facilitator for activity exercise can decrease limb volume in lymphedema and provide a supportive element for the treatment of this disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31613 0
Address 31613 0
Country 31613 0
Phone 31613 0
Fax 31613 0
Email 31613 0
Contact person for public queries
Name 14860 0
Jose Maria Pereira de Godoy
Address 14860 0
Av Constituicao 1306
Sao Jose do Rio Preto-Sao Paulo-Brazil
Zipe code: 15025-120
Country 14860 0
Brazil
Phone 14860 0
55 17 81556660
Fax 14860 0
Email 14860 0
[email protected]
Contact person for scientific queries
Name 5788 0
Maria de Fatima Guerreiro Godoy
Address 5788 0
Rua Floriano Peixoto 2950
Sao Jose do Rio Preto-Sao Paulo-Brazil
Zipe code:15020010
Country 5788 0
Brazil
Phone 5788 0
55 17 32326362
Fax 5788 0
Email 5788 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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