Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000084088
Ethics application status
Approved
Date submitted
18/01/2010
Date registered
25/01/2010
Date last updated
25/01/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Relationship between the BODE index and quality of life of patients with chronic obstructive pulmonary disease (COPD)
Scientific title
Uncontrolled cross-sectional study, correlation between BODE index and quality of life of patients with chronic obstructive pulmonary disease (COPD)
Secondary ID [1] 1309 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD 256591 0
Condition category
Condition code
Respiratory 256757 256757 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study measured the quality of life and the BODE index.
Quality of life was assessed by questionnaire St George's Respiratory Questionnaire (SGRQ). This questionnaire has a scale ranging from 0 to 100%, and the higher the score, the higher the quality of life of the patient. The BODE index was calculated according to the body mass index (BMI), forced expiratory volume in the first second (FEV1) post-bronchodilator, the 6-minute walk test (6MWD) and degree of dyspnea. The BODE index has a scale of 0 to 10 points, and the closer to ten, the worse the prognosis.
The correlation between the quality of life and the BODE index was assessed using Pearson correlation.
The study lasted 4 years.
Intervention code [1] 255842 0
Not applicable
Comparator / control treatment
Measurement of quality of life and the BODE index in a single moment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 257635 0
The primary outcome of this study is the relationship between the quality of life and BODE index.
Quality of life was assessed by questionnaire St George's Respiratory Questionnaire (SGRQ). This questionnaire has a scale ranging from 0 to 100%, and the higher the score, the higher the quality of life of the patient.
The BODE index was calculated according to the BMI, FEV1 post-bronchodilator, the 6MWD and degree of dyspnea. All these measures were undertaken. The BODE index has a scale of 0 to 10 points, and the closer to ten, the worse the prognosis. The correlation between the quality of life and the BODE index was assessed using Pearson correlation.
Timepoint [1] 257635 0
Relationship between quality of life and the BODE index measured at the end of the data analysis. Since the data analysis was done from 2004 to 2007.
Secondary outcome [1] 262906 0
Nil
Timepoint [1] 262906 0
Nil

Eligibility
Key inclusion criteria
This study included patients with COPD admitted to the Pulmonary Rehabilitation program at the Catholic University of Brasilia, all ex-smokers for at least six months and were clinically stable, ie no exacerbation of the disease
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
We excluded patients who had a comorbidity that causes changes in pulmonary function or physical limitation.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
49
Accrual to date
Final
Recruitment outside Australia
Country [1] 2416 0
Brazil
State/province [1] 2416 0

Funding & Sponsors
Funding source category [1] 256341 0
Hospital
Name [1] 256341 0
Hospital das Forcas Armadas
Country [1] 256341 0
Brazil
Primary sponsor type
Hospital
Name
Hospital das Forças Armadas
Address
Hospital das Forças Armadas, Clínica de Pneumologia, Estrada Contorno do Bosque, s/nº, Bairro: Cruzeiro Novo, Brasília – DF, CEP: 70603-900
Country
Brazil
Secondary sponsor category [1] 251655 0
Government body
Name [1] 251655 0
Ministerio da Defesa
Address [1] 251655 0
Ministerio da Defesa, Esplanada dos Ministerios Bloco Q, 7 andar, sala 723, Cep: 70.049-900 - Brasilia, DF.
Country [1] 251655 0
Brazil
Other collaborator category [1] 1040 0
Individual
Name [1] 1040 0
Renata Claudia Zanchet.
Address [1] 1040 0
Renata Claudia Zanchet. Hospital das Forcas Armadas, Clinica de Pneumologia, Estrada Contorno do Bosque, s/n, Bairro: Cruzeiro Novo, Brasilia, DF, CEP: 70603-900
Country [1] 1040 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258413 0
Comite de Etica da Universidade Catolica de Brasilia
Ethics committee address [1] 258413 0
Ethics committee country [1] 258413 0
Brazil
Date submitted for ethics approval [1] 258413 0
Approval date [1] 258413 0
Ethics approval number [1] 258413 0
82/2007

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30721 0
Address 30721 0
Country 30721 0
Phone 30721 0
Fax 30721 0
Email 30721 0
Contact person for public queries
Name 13968 0
Renata Claudia Zanchet
Address 13968 0
Hospital das Forças Armadas, Clinica de Pneumologia, Estrada Contorno do Bosque, s/n, Bairro: Cruzeiro Novo, Brasilia, DF, CEP: 70603-900
Country 13968 0
Brazil
Phone 13968 0
+55 61 3966 2318
Fax 13968 0
Email 13968 0
[email protected]
Contact person for scientific queries
Name 4896 0
Renata Claudia Zanchet
Address 4896 0
Hospital das Forças Armadas, Clinica de Pneumologia, Estrada Contorno do Bosque, s/n, Bairro: Cruzeiro Novo, Brasilia, DF, CEP: 70603-900
Country 4896 0
Brazil
Phone 4896 0
+55 61 3966 2318
Fax 4896 0
Email 4896 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
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Documents added automatically
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