Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000618459
Ethics application status
Approved
Date submitted
27/11/2007
Date registered
29/11/2007
Date last updated
29/11/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Correlation between Mild Hypoxemia and Limb Skeletal Muscle Function in Chronic Obstructive Pulmonary Disease – Pilot Study
Scientific title
Correlation between Mild Hypoxemia and Limb Skeletal Muscle Function
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 2585 0
Condition category
Condition code
Respiratory 2707 2707 0 0
Asthma

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The lung function was evaluated by spirometry and arterial blood gas analysis, and the functional evaluation by 6 minute walk distance and by isometric contraction of deltoid and quadriceps muscles. Observation time: one year
Intervention code [1] 2318 0
Not applicable
Comparator / control treatment
No treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3594 0
The mild hypoxemia and the precocious limb muscular disability have decrease functional capacity as main negative impact in COPD patients
Timepoint [1] 3594 0
At first 6 minute walk distance (6-MWD) and at isometric contraction of deltoid and quadriceps muscles
Secondary outcome [1] 6019 0
The arterial pressure of oxygen (PaO2) has important correlations with variables of muscular function
Timepoint [1] 6019 0
At first isometric contraction of quadriceps

Eligibility
Key inclusion criteria
COPD Patients
PaO2 = 56 - 59 mmHg
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Concomitant heart failure, diseases with mobility impairment, and medical conditions that were contraindicated for exercise testing

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 698 0
Brazil
State/province [1] 698 0
Distrito Federal

Funding & Sponsors
Funding source category [1] 2828 0
University
Name [1] 2828 0
University of Brasilia
Country [1] 2828 0
Brazil
Primary sponsor type
Individual
Name
Sergio Leite Rodrigues
Address
R 05 Norte Lote 02 bl. B Apto 1304 Águas Claras 71907-720 Brasilia - DF Brazil
Country
Brazil
Secondary sponsor category [1] 2554 0
None
Name [1] 2554 0
Address [1] 2554 0
Country [1] 2554 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4764 0
Comite de Etica em Pesquisa
Ethics committee address [1] 4764 0
Campus Universitario Darcy Ribeiro - Asa Norte
70.910-900 Brasilia DF Brazil
Ethics committee country [1] 4764 0
Brazil
Date submitted for ethics approval [1] 4764 0
27/11/2007
Approval date [1] 4764 0
Ethics approval number [1] 4764 0

Summary
Brief summary
To investigate the correlation between PaO2 and muscular strength, muscular fatigue and functional capacity in COPD patients
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28213 0
Address 28213 0
Country 28213 0
Phone 28213 0
Fax 28213 0
Email 28213 0
Contact person for public queries
Name 11370 0
Sergio Leite Rodrigues
Address 11370 0
R 05 Norte Lote 02 bl. B Apto 1304 Águas Claras 71907-720 Brasilia DF Brazil
Country 11370 0
Brazil
Phone 11370 0
55 61 81323156
Fax 11370 0
55 61 33073224
Email 11370 0
[email protected]
Contact person for scientific queries
Name 2298 0
Sergio Leite Rodrigues
Address 2298 0
R 05 Norte Lote 02 bl. B Apto 1304 Águas Claras 71907-720 Brasilia DF Brazil
Country 2298 0
Brazil
Phone 2298 0
55 61 81323156
Fax 2298 0
55 61 33073224
Email 2298 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
No additional documents have been identified.