Three-min Step Test and Exercise Desaturation Detection in Chronic Respiratory Insufficiency Patients

NCT ID: NCT04911764

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-15

Study Completion Date

2023-10-24

Brief Summary

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The study project will aim at the evaluation of the occurrence of exercise desaturation phenomenon during two different modalities of exercise (walking and stepping condition). This study will allow determining the sensibility of the 3-minute step test to detect exercise desaturation, in comparison with the gold standard (6-minute walking test). The 3-minute step test could therefore appear as a complementary tool for the evaluation of oxygen desaturation in chronic respiratory disease.

Detailed Description

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The 6-minute walking test is currently the gold standard for the evaluation of oxygen desaturation phenomenon during exercise and for the adjustment of O2 flow rate. But, due to spatial constraints, this test remains difficult to apply in ecological conditions and the 3-minute step test could be a complementary method to the walking test for the evaluation of chronic respiratory diseases. For this study, patients will perform, during 2 visits, a maximal graded test and two field tests (6-min walking test and 3-min step test) under identical conditions. During these tests, pulsed oxygen saturation and psycho-physiological adaptations to exercise will be monitored.

Conditions

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COPD Chronic Respiratory Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective non-randomized interventional study, with low risks and constraints.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Three-min Step Test and Exercise desaturation detection in COPD

Each patient recruited will performed both field tests, being therefore his or her own witness.

Group Type EXPERIMENTAL

Three-min Step Test and Exercise desaturation detection in COPD

Intervention Type DIAGNOSTIC_TEST

For this research, 2 visits will be scheduled (V1 and V2) for each patient. During V1, after collecting the filled and signed consent form from the patient, anthropometric measurements and pulmonary function assessment will be performed before the realization of a maximal graded test. This inclusion visit will be carried out as part of an inclusion within a respiratory rehabilitation program. During V2, each patient will randomly perform a 6-minute walking test and a 3-minute step test, in similar standard conditions. A 30-minute resting period will be allowed between the two field tests. During the realization of the tests, cardio-respiratory adaptations will be monitored throughout both tests with portable gas analyzer and pulsed oxymetry system.

Interventions

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Three-min Step Test and Exercise desaturation detection in COPD

For this research, 2 visits will be scheduled (V1 and V2) for each patient. During V1, after collecting the filled and signed consent form from the patient, anthropometric measurements and pulmonary function assessment will be performed before the realization of a maximal graded test. This inclusion visit will be carried out as part of an inclusion within a respiratory rehabilitation program. During V2, each patient will randomly perform a 6-minute walking test and a 3-minute step test, in similar standard conditions. A 30-minute resting period will be allowed between the two field tests. During the realization of the tests, cardio-respiratory adaptations will be monitored throughout both tests with portable gas analyzer and pulsed oxymetry system.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients aged by 18 and more ;
* Patient with an chronic obstructive respiratory insufficiency, confirmed by clinical and functional criteria ;
* Patient with exercise-induced oxygen desaturation ;
* Patient clinical ly stable, with no exacerbation period within the last 2 months before inclusion ;
* Consent form signed by the patient.

Exclusion Criteria

* Patient in exacerbation period at the inclusion time ;
* Pregnant and breastfeeding women ;
* Patient with orthopedic disorder that could limit the ability of stair climbing;
* Any other disease that could influence exercise capacity of the patient or that could impair exercise test realization ;
* Patient with law protection (guardianship or protection of vulnerable adults)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Limoges

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Florent FAVARD, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Limoges

Locations

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Chu de Limoges

Limoges, , France

Site Status

Countries

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France

References

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ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available.

Reference Type BACKGROUND
PMID: 12091180 (View on PubMed)

Anthonisen NR. Prognosis in chronic obstructive pulmonary disease: results from multicenter clinical trials. Am Rev Respir Dis. 1989 Sep;140(3 Pt 2):S95-9. doi: 10.1164/ajrccm/140.3_Pt_2.S95. No abstract available.

Reference Type BACKGROUND
PMID: 2675713 (View on PubMed)

Barjaktarevic I, Cooper CB. Supplemental Oxygen Therapy for Patients with Chronic Obstructive Pulmonary Disease. Semin Respir Crit Care Med. 2015 Aug;36(4):552-66. doi: 10.1055/s-0035-1556058. Epub 2015 Aug 3.

Reference Type BACKGROUND
PMID: 26238641 (View on PubMed)

Borel B, Wilkinson-Maitland CA, Hamilton A, Bourbeau J, Perrault H, Jensen D, Maltais F. Three-minute constant rate step test for detecting exertional dyspnea relief after bronchodilation in COPD. Int J Chron Obstruct Pulmon Dis. 2016 Nov 29;11:2991-3000. doi: 10.2147/COPD.S113113. eCollection 2016.

Reference Type BACKGROUND
PMID: 27942208 (View on PubMed)

Borel, B., C. Wilkinson-Maitland, D. Jensen, J. Bourbeau, A. Hamilton, H. Perrault and F. Maltais. Sensitivity of the 3-min step test to detect dyspnea relief following bronchodilation in COPD: a randomized control trial. American journal of respiratory and critical care medicine. 2014;189: A5862.

Reference Type BACKGROUND

Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.

Reference Type BACKGROUND
PMID: 7154893 (View on PubMed)

Long term domiciliary oxygen therapy in chronic hypoxic cor pulmonale complicating chronic bronchitis and emphysema. Report of the Medical Research Council Working Party. Lancet. 1981 Mar 28;1(8222):681-6.

Reference Type BACKGROUND
PMID: 6110912 (View on PubMed)

Casanova C, Cote C, Marin JM, Pinto-Plata V, de Torres JP, Aguirre-Jaime A, Vassaux C, Celli BR. Distance and oxygen desaturation during the 6-min walk test as predictors of long-term mortality in patients with COPD. Chest. 2008 Oct;134(4):746-752. doi: 10.1378/chest.08-0520. Epub 2008 Jul 14.

Reference Type BACKGROUND
PMID: 18625667 (View on PubMed)

Garcia-Talavera I, Tauroni A, Trujillo JL, Pitti R, Eiroa L, Aguirre-Jaime A, Sanchez A, Abreu J. Time to desaturation less than one minute predicts the need for long-term home oxygen therapy. Respir Care. 2011 Nov;56(11):1812-7. doi: 10.4187/respcare.01164. Epub 2011 May 20.

Reference Type BACKGROUND
PMID: 21605486 (View on PubMed)

Perrault H, Baril J, Henophy S, Rycroft A, Bourbeau J, Maltais F. Paced-walk and step tests to assess exertional dyspnea in COPD. COPD. 2009 Oct;6(5):330-9. doi: 10.1080/15412550903156317.

Reference Type BACKGROUND
PMID: 19863362 (View on PubMed)

Poulain M, Durand F, Palomba B, Ceugniet F, Desplan J, Varray A, Prefaut C. 6-minute walk testing is more sensitive than maximal incremental cycle testing for detecting oxygen desaturation in patients with COPD. Chest. 2003 May;123(5):1401-7. doi: 10.1378/chest.123.5.1401.

Reference Type BACKGROUND
PMID: 12740254 (View on PubMed)

Takigawa N, Tada A, Soda R, Date H, Yamashita M, Endo S, Takahashi S, Kawata N, Shibayama T, Hamada N, Sakaguchi M, Hirano A, Kimura G, Okada C, Takahashi K. Distance and oxygen desaturation in 6-min walk test predict prognosis in COPD patients. Respir Med. 2007 Mar;101(3):561-7. doi: 10.1016/j.rmed.2006.06.017. Epub 2006 Aug 8.

Reference Type BACKGROUND
PMID: 16899358 (View on PubMed)

Other Identifiers

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87RI19-0003_STEPSAT

Identifier Type: -

Identifier Source: org_study_id

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