World Health Organization site
Skip Navigation Links

Main
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.
Register: REBEC
Last refreshed on: 29 April 2013
Main ID:  RBR-7bqxm2
Date of registration: 18/06/2012
Primary sponsor: Universidade Federal do Rio Grande do Norte - UFRN - Natal, RN, Brazil
Public title: Expenses and benefits of a physical activity program in chronic obstructive pulmonary disease
Scientific title: Assessment of costs and benefits of a physical activity program for Chronic Obstructive Pulmonary Disease: implementation and Primary Care Units in the SUS
Date of first enrolment: 06/05/2011
Target sample size: 40
Recruitment status: data analysis completed
URL:  http://www.ensaiosclinicos.gov.br/rg/RBR-7bqxm2/
Study type: 
Study design:  Parallel, single-blinded, two arms, randomized clinical trial  
Countries of recruitment
Brazil
Contacts
Name: Catharinne  Carvalho de Farias
Address:  Caixa Postal 1524 - Campus Universitário Lagoa Nova 59078970 Natal Brazil
Telephone: (84)33422013
Email: cathfarias@hotmail.com
Affiliation:  Universidade Federal do Rio Grande do Norte - UFRN
Name: Guilherme  Freitas Fregonezi
Address:  Caixa Postal 1524 - Campus Universitário Lagoa Nova 59078970 Natal Brazil
Telephone: (84)33422013
Email: fregonezi@ufrnet.br
Affiliation:  Universidade Federal do Rio Grande do Norte - UFRN
Key inclusion & exclusion criteria
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: -
Health Condition(s) or Problem(s) studied
Cronic Obstrutive Pulmonary Diseases
C08.381.495.389
Intervention(s)
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.
Primary Outcome(s)
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
Secondary Outcome(s)
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.
Secondary ID(s)
Certificado de Apresentação para Apreciação Ética (CAAE): 0029.0.294.000/10
Source(s) of Monetary Support
Conselho Nacional de Desenvolvimento Científico e Tecnológico - Brasília, DF, Brazil
Universidade Federal do Rio Grande do Norte - UFRN - Natal, RN, Brazil
Secondary Sponsor(s)
Universidade Federal do Rio Grande do Norte - UFRN - Natal, RN, Brazil
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.1 - Version history