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

NCT04911764 | Completed

• 1 other identifier: 87RI19-0003_STEPSAT
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

COPD; Chronic Respiratory Disease

Keywords

COPD; Exercise; oxygen desaturation; field tests

Outcome Measures

Primary Outcomes (1)

• Detection of exercise desaturation occurrence

  Detection of exercise desaturation occurrence correspond to a fall of SpO2 rest value by at least 4 points during exercise, assessed with the measurement of pulsed oxygen saturation during the different tests.

  At Visit 2: between Day 3 and Day 15 after Visit 1

Secondary Outcomes (7)

• Patient-perceived sensation of dyspnea

  At Visit 2: between Day 3 and Day 15 after Visit 1

• Patient-perceived sensation of lower extremity fatigue

  At Visit 2: between Day 3 and Day 15 after Visit 1

• Oxygen consumption (VO2)

  At Visit 2: between Day 3 and Day 15 after Visit 1

• CO2 production (VCO2)

  At Visit 2: between Day 3 and Day 15 after Visit 1

• Ventilatory output (VE)

  At Visit 2: between Day 3 and Day 15 after Visit 1

Study Arms (1)

Three-min Step Test and Exercise desaturation detection in COPD

EXPERIMENTAL

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

Diagnostic Test: Three-min Step Test and Exercise desaturation detection in COPD

Interventions

Three-min Step Test and Exercise desaturation detection in COPD 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.

Three-min Step Test and Exercise desaturation detection in COPD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ;
• Consent form signed by the patient.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

Chu de Limoges

Limoges, 87000, France

Location

Related Publications (12)

• 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.

  PMID: 12091180 BACKGROUND

• 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.

  PMID: 2675713 BACKGROUND

• 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.

  PMID: 26238641 BACKGROUND

• 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.

  PMID: 27942208 BACKGROUND

• 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.

  BACKGROUND

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

  PMID: 7154893 BACKGROUND

• 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.

  PMID: 6110912 BACKGROUND

• 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.

  PMID: 18625667 BACKGROUND

• 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.

  PMID: 21605486 BACKGROUND

• 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.

  PMID: 19863362 BACKGROUND

• 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.

  PMID: 12740254 BACKGROUND

• 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.

  PMID: 16899358 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Florent FAVARD, MD

  University Hospital, Limoges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective non-randomized interventional study, with low risks and constraints.

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: June 3, 2021
• Study Start: April 15, 2022
• Primary Completion: October 24, 2023
• Study Completion: October 24, 2023
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)