COPDSTEPSATNCT04911764
Three-min Step Test and Exercise Desaturation Detection in Chronic Respiratory Insufficiency Patients
A study testing Three-min Step Test and Exercise desaturation detection in COPD in people with COPD and Chronic Respiratory Disease, run by University Hospital, Limoges at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Chronic Respiratory Disease
- What is being tested?
- Three-min Step Test and Exercise desaturation detection in COPD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2022to 24 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ability of the 3-minute Step Test Protocol for Detecting Exercise Desaturation Episodes in Chronic Respiratory Insufficiency: Protocol STEPSAT: Three-min Step Test and Exercise Desaturation Detection in Chronic Respiratory Insufficiency Patients
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.
Read the detailed description
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
- COPD, Chronic Respiratory Disease
- Being tested
- Three-min Step Test and Exercise desaturation detection in COPD
- Keywords
- COPD, Exercise, oxygen desaturation, field tests
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-min Step Test and Exercise desaturation detection in COPDDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Three-min Step Test and Exercise desaturation detection in COPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Visit 2: between Day 3 and Day 15 after Visit 1
Secondary outcomes (7)
Patient-perceived sensation of dyspnea
scoring by Borg Category Ratio 10 scale (CR-10)
- Scale going from 0 to 10
- 0 being an absence of sensation, 10 a very high sensation or even maximum.
Measured: At Visit 2: between Day 3 and Day 15 after Visit 1
Patient-perceived sensation of lower extremity fatigue
scoring by Borg Category Ratio 10 scale (CR-10)
- Scale going from 0 to 10
- 0 being an absence of sensation, 10 a very high sensation or even maximum.
Measured: At Visit 2: between Day 3 and Day 15 after Visit 1
Oxygen consumption (VO2)
This parameter will be obtained from a measuring device (Metamax), allowing a real time measurement and its registration will be collected at the end of the walking and stepping tests.
Reported value in ml/min/kg : mean value of the last thirty seconds of each test.
Measured: At Visit 2: between Day 3 and Day 15 after Visit 1
CO2 production (VCO2)
This parameter will be obtained from a measuring device (Metamax), allowing a real time measurement and its registration will be collected at the end of the walking and stepping tests.
Reported value in ml/min/kg : mean value of the last thirty seconds of each test.
Measured: At Visit 2: between Day 3 and Day 15 after Visit 1
Ventilatory output (VE)
This parameter will be obtained from a measuring device (Metamax), allowing a real time measurement and its registration will be collected at the end of the walking and stepping tests.
Reported value in l/min : mean value of the last thirty seconds of each test.
Measured: At Visit 2: between Day 3 and Day 15 after Visit 1
Heart rate (HR)
This parameter will be obtained from a measuring device (Metamax), allowing a real time measurement and its registration will be collected at the end of the walking and stepping tests.
Reported value in Beats/min : mean value of the last thirty seconds of each test.
Measured: At Visit 2: between Day 3 and Day 15 after Visit 1
Muscle deoxygenation (delta HHb)
The assessment of muscle deoxygenation observed by near infrared spectroscopy (NIRS) technology.
Reported value in arbitrary unit : difference between mean HHb value at rest and the lowest HHb value during each exercise
Measured: At Visit 2: between Day 3 and Day 15 after Visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start15 Apr 2022
- Primary completion24 Oct 2023
- Study completion24 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective non-randomized interventional study, with low risks and constraints.
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florent FAVARD, MD, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911764
- Sponsor's protocol ID
- 87RI19-0003_STEPSAT
- Acronym
- STEPSAT
- Status last verified
- Jun 2025
- First submitted
- 20 May 2021
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 12091180Anthonisen 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.
PubMed 2675713Barjaktarevic 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.
PubMed 26238641Borel 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.
PubMed 27942208Borel, 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.
Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
PubMed 7154893Long 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.
PubMed 6110912Casanova 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.
PubMed 18625667Garcia-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.
PubMed 21605486Perrault 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.
PubMed 19863362Poulain 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.
PubMed 12740254Takigawa 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.
PubMed 16899358
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ability of the 3-minute Step Test Protocol for Detecting Exercise Desaturation Episodes in Chronic Respiratory Insufficiency: Protocol STEPSAT: Three-min Step Test and Exercise Desaturation Detection in Chronic Respiratory Insufficiency Patients
- ClinicalTrials.gov ID
- NCT04911764
- Acronym / sponsor ID
- STEPSAT / 87RI19-0003_STEPSAT
- Conditions
- COPD, Chronic Respiratory Disease
- Keywords
- COPD, Exercise, oxygen desaturation, field tests
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 24 Oct 2023 (actual)
- Study completion
- 24 Oct 2023 (actual)
- First posted
- 3 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective non-randomized interventional study, with low risks and constraints.
| Arm | Type | Receives |
|---|---|---|
| Three-min Step Test and Exercise desaturation detection in COPD | Experimental | Diagnostic Test: Three-min Step Test and Exercise desaturation detection in COPDEach patient recruited will performed both field tests, being therefore his or her own witness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Three-min Step Test and Exercise desaturation detection in COPDFor 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. | Diagnostic test | Three-min Step Test and Exercise desaturation detection in COPD |
Primary outcome
Detection of exercise desaturation occurrence
Time frame: At Visit 2: between Day 3 and Day 15 after Visit 1
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.
7 secondary outcomes
Patient-perceived sensation of dyspnea
Time frame: At Visit 2: between Day 3 and Day 15 after Visit 1
Patient-perceived sensation of lower extremity fatigue
Time frame: At Visit 2: between Day 3 and Day 15 after Visit 1
Oxygen consumption (VO2)
Time frame: At Visit 2: between Day 3 and Day 15 after Visit 1
CO2 production (VCO2)
Time frame: At Visit 2: between Day 3 and Day 15 after Visit 1
Ventilatory output (VE)
Time frame: At Visit 2: between Day 3 and Day 15 after Visit 1
Heart rate (HR)
Time frame: At Visit 2: between Day 3 and Day 15 after Visit 1
Muscle deoxygenation (delta HHb)
Time frame: At Visit 2: between Day 3 and Day 15 after Visit 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Background: PubMed 12091180ATS 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.
- Background: PubMed 2675713Anthonisen 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.
- Background: PubMed 26238641Barjaktarevic 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.
- Background: PubMed 27942208Borel 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.
- BackgroundBorel, 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: PubMed 7154893Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
- Background: PubMed 6110912Long 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.
- Background: PubMed 18625667Casanova 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.
- Background: PubMed 21605486Garcia-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.
- Background: PubMed 19863362Perrault 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.
- Background: PubMed 12740254Poulain 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.
- Background: PubMed 16899358Takigawa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florent FAVARD, MD principal investigator
University Hospital, Limoges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Three-min Step Test and Exercise desaturation detection in COPD in people with COPD and Chronic Respiratory Disease, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of exercise desaturation occurrence (time frame: At Visit 2: between Day 3 and Day 15 after Visit 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04911764, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.