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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02348151
Other study ID # DPOCPC
Secondary ID
Status Recruiting
Phase N/A
First received January 22, 2015
Last updated March 9, 2015
Start date January 2014
Est. completion date June 2016

Study information

Verified date March 2015
Source University of Nove de Julho
Contact Fernanda C Lanza, PhD
Phone 55113385-9241
Email lanza@uninove.br
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical Trial Summary

It is still not clearly known whether doing the walk test in a course is different from doing it on a treadmill in the lack of a ten-meter-long corridor. In case of a positive outcome in this study, we will have an alternative for this test in places where there is not enough room, benefiting the assessment of COPD patients' functional capacity. In the literature, there are still some controversies about performing the test on a treadmill or in a corridor and whether there is interference with the distance walked. Our hypothesis is that there is no interference with the distance walked, and thus we have one more option to perform the test in case there is no 10-meter corridor available.


Description:

Spirometry tests will be performed using ULTIMA CPX equipment. Volunteers will perform the tests twice, on different days (see protocol description), in a corridor and on a treadmill, until reaching their limit of tolerance. In the test performed on the treadmill and in the one performed in the corridor, subjects will simultaneously use the VO 2000. And the volunteers will fill out the Saint George's Respiratory Questionnaire (SGRQ).


Recruitment information / eligibility

Status Recruiting
Enrollment 47
Est. completion date June 2016
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- clinically stable

- not dependent on oxygen to exercise

- diagnosis of COPD according to the GOLD

Exclusion Criteria:

- cognitive deficit or musculoskeletal

- in process of exacerbation

- have performed pulmonary rehabilitation

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
Treadmill
The volunteers will perform the shuttle walk test on the treadmill
Corridor
The volunteers will perform the shuttle walk test on the corridor

Locations

Country Name City State
Brazil Patricia Lira dos Santos Mogi das Cruzes São Paulo/Mogi das Cruzes

Sponsors (1)

Lead Sponsor Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Singh SJ, Morgan MD, Scott S, Walters D, Hardman AE. Development of a shuttle walking test of disability in patients with chronic airways obstruction. Thorax. 1992 Dec;47(12):1019-24. — View Citation

Stevens D, Elpern E, Sharma K, Szidon P, Ankin M, Kesten S. Comparison of hallway and treadmill six-minute walk tests. Am J Respir Crit Care Med. 1999 Nov;160(5 Pt 1):1540-3. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The distance reached in shuttle walk test two year No
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