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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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REBEC |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
RBR-7bqxm2 |
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Date of registration:
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18/06/2012 |
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Primary sponsor: |
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Public title:
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Expenses and benefits of a physical activity program in chronic obstructive pulmonary disease
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Scientific title:
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Assessment of costs and benefits of a physical activity program for Chronic Obstructive Pulmonary Disease: implementation and Primary Care Units in the SUS |
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Date of first enrolment:
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06/05/2011 |
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Target sample size:
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40 |
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Recruitment status: |
data analysis completed |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-7bqxm2/ |
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Study type:
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Study design:
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Parallel, single-blinded, two arms, randomized clinical trial
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Catharinne
Carvalho de Farias |
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Address:
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Caixa Postal 1524 - Campus Universitário Lagoa Nova
59078970
Natal
Brazil |
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Telephone:
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(84)33422013 |
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Email:
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cathfarias@hotmail.com |
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Affiliation:
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Universidade Federal do Rio Grande do Norte - UFRN |
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Name:
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Guilherme
Freitas Fregonezi |
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Address:
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Caixa Postal 1524 - Campus Universitário Lagoa Nova
59078970
Natal
Brazil |
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Telephone:
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(84)33422013 |
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Email:
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fregonezi@ufrnet.br |
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Affiliation:
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Universidade Federal do Rio Grande do Norte - UFRN |
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Key inclusion & exclusion criteria
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Inclusion criteria: In medical treatment by a pulmonologist;
Age between 40 and 85 years;
Do not make use of oxygen;
No exacerbations in the last three months;
Do not be practicing regular physical activity over the past six months.
Exclusion criteria: Musculoskeletal comorbidities that interfere in the running;
Decrease the peripheral oxygen saturation (SpO2) <90% during the submaximal exercise test;
Difficulty in understanding intellectual who prevented them from carrying out the assessment activities;
Abandoning the practice of physical activity proposed;
Did not attend for reassessment.
Age minimum:
40Y
Age maximum:
85Y
Gender:
-
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Health Condition(s) or Problem(s) studied
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Cronic Obstrutive Pulmonary Diseases C08.381.495.389
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Intervention(s)
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A group of 20 individuals will perform the physical activity of walking five days per week and two days of walking three days supervised and unsupervised, with a total of eight weeks. The activity will be held daily walk with the speed according to individual tolerance of the patient, based on the subjective sensation reported by the modified Borg scale, which ranges from 0 to ten, where zero is no dyspnoea and ten is the highest dyspnea reported by the individual . The control group consisted of 20 individuals did not perform the physical activity program proposed by us, but after completion of the study will be offered the same intervention performed in another group. Both groups will be evaluated after the completion of the physical activity program.
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Primary Outcome(s)
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Increasing the distance covered by the test decaminhada 6 minutes. Improved quality of life questionnaire through Saint George, where the lower the value obtained, the lower the impact of disease on quality of life. Expected to lower scores after the intervention. Increased capacity to develop the activities of daily living, using the questionnaire of activities of daily living London Chest, whose scale is divided into four areas: personal care, home care, physical activity and leisure. The total score is the sum of all domains. It is expected highest scores after the intervention. Increase in peripheral muscle strength, assessed by evaluating the handgrip and repetition maximum for the dominant leg. Reduction in mortality score by analyzing the BODE index, used as an indirect predictor of death risk. Four factors are used to calculate it: body mass index, degree of airway obstruction, dyspnea and exercise capacity measured by testing 6-minute walk. High levels are associated with an increased risk of death. It is expected then low rates after the intervention. Decreased sensation of dyspnea, measured during the test 6-minute walk through the modified Borg scale ranging from 0 to 10 points, and the patient who chooses the intensity of dyspnea and degree of muscular discomfort consistent with the time. Expected to be found after the intervention values ??less
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Secondary Outcome(s)
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Lower costs related to procedimntos assessment, treatment and re-walk, and related exacerbations and hospitalizations in subjects under study were consistent with those expected benefits.
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Secondary ID(s)
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Certificado de Apresentação para Apreciação Ética (CAAE): 0029.0.294.000/10
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Source(s) of Monetary Support
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Conselho Nacional de Desenvolvimento Científico e Tecnológico - Brasília, DF, Brazil
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Universidade Federal do Rio Grande do Norte - UFRN - Natal, RN, Brazil
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