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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02873780
Other study ID # BE403201317621
Secondary ID
Status Completed
Phase N/A
First received July 31, 2016
Last updated January 30, 2017
Start date July 2016
Est. completion date September 2016

Study information

Verified date January 2017
Source Centre Hospitalier des Pays de Morlaix
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to compare oxygen desaturation during two tests: the 6 minute walk test and the 3 minute step test, for COPD patients.


Description:

The 6 minute walk test (6MWT) is the best field test to determine oxygen desaturation during effort, in COPD patients. However, the test need a 30m corridor.

The 3 minute step test (3MST) is a other field test used in COPD patients. But no study shows that 3MST can be used to determine oxygen desaturation.

The aim of this study is to compare oxygen desaturation during these to tests : the 6MWT and the 3MST.

50 patients will be included in this study.

Patients realize two 6MWT and two 3MST, with rest between each test.

Oxygen saturation, heart rate are registered during the tests, dyspnea, leg peniblility are notified before and after each test, distance or number of steps are noted.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender All
Age group 40 Years to 90 Years
Eligibility Inclusion Criteria:

- stable COPD patients hospitalized for pulmonary rehabilitation program

Exclusion Criteria:

- acute exacerbation of COPD

- incapacity to realize the tests

- absence of written informed consent

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France CH Des pays de Morlaix Morlaix

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier des Pays de Morlaix Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

France, 

References & Publications (3)

Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An o — View Citation

Polkey MI, Spruit MA, Edwards LD, Watkins ML, Pinto-Plata V, Vestbo J, Calverley PM, Tal-Singer R, Agustí A, Bakke PS, Coxson HO, Lomas DA, MacNee W, Rennard S, Silverman EK, Miller BE, Crim C, Yates J, Wouters EF, Celli B; Evaluation of COPD Longitudinal — View Citation

Roberts MM, Cho JG, Sandoz JS, Wheatley JR. Oxygen desaturation and adverse events during 6-min walk testing in patients with COPD. Respirology. 2015 Apr;20(3):419-25. doi: 10.1111/resp.12471. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary oxygen saturation oxygen saturation is compared between 6MWT and 3MST at the end of the 2 tests 3 minutes
Secondary heart rate heart rate is compared between 6MWT and 3MST at the end of the 2 tests 3 minutes
Secondary dyspnea (Borg Scale) dyspnea (Borg Scale) is compared between 6MWT and 3MST at the end of the 2 tests 3 minutes
Secondary leg penibility (Borg Scale) leg penibility (Borg Scale) is compared between 6MWT and 3MST at the end of the 2 tests 3 minutes
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