Clinical trial NCT02873780: Comparison of 3-Minute Step Test (3MStepT) and 6-Minute Walk Test (6MWT) in COPD Patients
Official title: Comparison of 3-Minute Step Test (3MStepT) and 6-Minute Walk Test (6MWT) in Chronic Obstructive Pulmonary Disease Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Chronic Obstructive Pulmonary Disease
Keywords: Pulmonary rehabilitation
COPD
Evaluation
oxygen desaturation
exercise capacity
Lead sponsor: Centre Hospitalier des Pays de Morlaix
Sponsor class: OTHER
Collaborators: name: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
First posted: 2016-08-22
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: COPD patients hospitalized for pulmonary rehabilitation program

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: oxygen saturation
timeFrame: 3 minutes
Secondary outcomes:
measure: heart rate
timeFrame: 3 minutes
measure: dyspnea (Borg Scale)
timeFrame: 3 minutes
measure: leg penibility (Borg Scale)
timeFrame: 3 minutes
Other outcomes:
Locations:
city: Morlaix
country: France
facility: CH Des pays de Morlaix
Study officials:
affiliation: France, Britain, CH Des Pays de Morlaix
name: Marc Beaumont, PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Belgium, Cliniques universitaires de Saint Luc
name: Gregory Reychler, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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. Epub 2015 Jan 20.
citation: Polkey MI, Spruit MA, Edwards LD, Watkins ML, Pinto-Plata V, Vestbo J, Calverley PM, Tal-Singer R, Agusti 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 Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) Study Investigators. Six-minute-walk test in chronic obstructive pulmonary disease: minimal clinically important difference for death or hospitalization. Am J Respir Crit Care Med. 2013 Feb 15;187(4):382-6. doi: 10.1164/rccm.201209-1596OC. Epub 2012 Dec 21.
citation: 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 official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.