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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.
Register: REBEC
Last refreshed on: 29 April 2013
Main ID:  RBR-48tgdd
Date of registration: 30/05/2012
Primary sponsor: Faculdade de Ciências e Tecnologia FCT/UNESP - Brazil
Public title: Using a low cost resistance exercise protocol in patients with chronic obstructive pulmonary disease
Scientific title: Physical, functional and quality of life in patients with chronic obstructive pulmonary disease in a program of strength training with elastic tubing
Date of first enrolment: 16/11/2011
Target sample size: 40
Recruitment status: recruitment completed
URL:  http://www.ensaiosclinicos.gov.br/rg/RBR-48tgdd/
Study type: 
Study design:  Therapeutic, parallel, with 2 arms, open, randomized clinical trial.  
Countries of recruitment
Brazil
Contacts
Name: Alessandra  Toledo
Address:  rua rui barbosa 1736/323 19015001 Presidente Prudente Brazil
Telephone: 11 85615969
Email: alechoqueta@yahoo.com.br
Affiliation:  Faculdade de Ciências e Tecnologia FCT/UNESP
Key inclusion & exclusion criteria
Inclusion criteria: Diagnosis of Chronic obstructive pulmonary disease (COPD) confirmed by spirometry according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria;
Age over 50 years;
Absence of associated pulmonary diseases.

Exclusion criteria: Occurrences of clinical instability;
Cardiac co-morbidities that would prevent musculoskeletal execution of the experimental protocol;
Congestive heart failure;
Diabetes;
Rheumatoid arthritis and presence of other systemic inflammatory diseases;
Irregular participation on the experimental protocol


Age minimum: 50
Age maximum: 80
Gender: -
Health Condition(s) or Problem(s) studied
Chronic obstructive pulmonary disease
C08.381.495.389
J00-J99
Intervention(s)
Patients will be randomized in two groups (n=20 in each group) and the intervention will be two protocols of resistance training: 1)elastic tubing and 2)weight machine, three times a week during one hour for eight weeks.
Primary Outcome(s)
Improvement on functional capacity, assessed by the 6 minutes Walking Test (6MWT) at the beginning and at the end of the training period.
Improvement in peripheral muscle strength, assessed by the measurement of maximal isometric force using a digital dynamometer, at the beginning and at the end of the training period.
Secondary Outcome(s)
It is expected to observe a better score on the questionnaire that reflects the improvement in quality of life after training.
Secondary ID(s)
número de aprovação no cep UNESP: 31/2009 (número CAAE 03773612.8.0000.5402)
Source(s) of Monetary Support
Faculdade de Ciências e Tecnologia FCT/UNESP - Brazil
Secondary Sponsor(s)
Faculdade de Ciências e Tecnologia FCT/UNESP - Brazil
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