Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000244909
Ethics application status
Approved
Date submitted
4/03/2011
Date registered
4/03/2011
Date last updated
16/03/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of six-minute walk distance and average speed in subjects with lung disorders.
Scientific title
Evaluation of six-minute walk distance and average speed in subjects with lung disorders
Secondary ID [1] 259733 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic obstructive respiratory disease 261312 0
interstitial pulmonary disease 261313 0
Condition category
Condition code
Respiratory 259464 259464 0 0
Chronic obstructive pulmonary disease
Respiratory 259465 259465 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The patients have been perform the Six-minute walk test according to American Thoracic Society. The test was performed only once
Intervention code [1] 264162 0
Not applicable
Comparator / control treatment
The patients were divided in three groups obstructive, restrictive and mixed from the lung functions results. And after compare the six-minute walk distance and average speed between the groups.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262276 0
Six-minute walk distance
Timepoint [1] 262276 0
at after performed the six-minute walk test
Primary outcome [2] 262277 0
Average speed in six-minute walk test
Timepoint [2] 262277 0
At during perfom test
Secondary outcome [1] 273441 0
Nil
Timepoint [1] 273441 0
Nil

Eligibility
Key inclusion criteria
Patients witih diagnosis of lung disorders.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Healthy subjects, patients with needed supplemental oxygen , and subjects with cardiovascular and neurological disorders

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
124
Accrual to date
Final
Recruitment outside Australia
Country [1] 3291 0
Brazil
State/province [1] 3291 0

Funding & Sponsors
Funding source category [1] 264613 0
Hospital
Name [1] 264613 0
Hospital de Clinicas
Country [1] 264613 0
Brazil
Funding source category [2] 264614 0
University
Name [2] 264614 0
Universidade Estadual de Campinas
Country [2] 264614 0
Brazil
Primary sponsor type
Individual
Name
Vinicius Minatel
Address
Cidade Universitaria Zeferino Vaz.
City: Campinas
UF: Sao Paulo, Brasil
Zip Code: 13083-888
Country
Brazil
Secondary sponsor category [1] 263751 0
Individual
Name [1] 263751 0
Ivet Alonso Bredda Saad
Address [1] 263751 0
Cidade Universitaria Zeferino Vaz.
City: Campinas
UF: Sao Paulo, Brasil
Zip Code: 13083-888
Country [1] 263751 0
Brazil

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The six-minute walking test (6MWT) is a submaximal clinic assessment tool, which has produced good results when employed in subjects with lung disease, diagnosticated as from a lung function test. However, the objectives of this studyare evaluate and compare the six-minute walking distance (6MWD) with predicted six-minute walking distance in different lung disorders; as well as the average speed during the 6MWT. Beyond to check if age, body-mass index, lung function and average speed can influence the 6MWT response. In this study was included 124 subjects with lung diseases, which have been divided in three groups: obstructive, restrictive and mixed from the lung functions results. Have been evaluated their anthropometrics and personal data, and then sent to perform the 6MWT according to ATS.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32310 0
Address 32310 0
Country 32310 0
Phone 32310 0
Fax 32310 0
Email 32310 0
Contact person for public queries
Name 15557 0
Vinicius Minatel
Address 15557 0
Cidade Universitaria Zeferino Vaz.
City: Campinas
UF: Sao Paulo, Brasil
Zip Code: 13083-888
Country 15557 0
Brazil
Phone 15557 0
+55 19 8101-8758
Fax 15557 0
Email 15557 0
[email protected]
Contact person for scientific queries
Name 6485 0
Vinicius Minatel
Address 6485 0
Cidade Universitaria Zeferino Vaz.
City: Campinas
UF: Sao Paulo, Brasil
Zip Code: 13083-888
Country 6485 0
Brazil
Phone 6485 0
+55 19 8101-8758
Fax 6485 0
Email 6485 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
No documents have been uploaded by study researchers.

Documents added automatically
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