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

Primary Purpose

COPD, Chronic Respiratory Disease

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Three-min Step Test and Exercise desaturation detection in COPD

About this trial

This is an interventional diagnostic trial for COPD focused on measuring COPD, Exercise, oxygen desaturation, field tests

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Three-min Step Test and Exercise desaturation detection in COPD

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

CO2 production (VCO2)

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.

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.

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

Full Information

NCT ID

NCT04911764

First Posted

May 20, 2021

Last Updated

May 27, 2021

Sponsor

University Hospital, Limoges

1. Study Identification

Unique Protocol Identification Number

NCT04911764

Brief Title

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

Acronym

STEPSAT

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

June 2021 (Anticipated)

Primary Completion Date

September 2022 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Limoges

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COPD, Chronic Respiratory Disease

Keywords

COPD, Exercise, oxygen desaturation, field tests

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Three-min Step Test and Exercise desaturation detection in COPD

Arm Type

Experimental

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

Three-min Step Test and Exercise desaturation detection in COPD

Intervention Description

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.

Primary Outcome Measure Information:

Title

Detection of exercise desaturation occurrence

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Patient-perceived sensation of dyspnea

Description

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.

Time Frame

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

Title

Patient-perceived sensation of lower extremity fatigue

Description

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.

Time Frame

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

Title

Oxygen consumption (VO2)

Description

Time Frame

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

Title

CO2 production (VCO2)

Description

Time Frame

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

Title

Ventilatory output (VE)

Description

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.

Time Frame

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

Title

Heart rate (HR)

Description

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.

Time Frame

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

Title

Muscle deoxygenation (delta HHb)

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

sandra JUGE, Project Manager

Phone

05 55 05 64 14

sandra.juge@chu-limoges.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Benoit BOREL, Maitre de conférence

Phone

05 55 45 76 32

benoit.borel@unilim.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Florent FAVARD, doctor

Organizational Affiliation

CHU de LIMOGES _ florent.favard@chu-limoges.fr

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

12091180

Citation

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. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.

Results Reference

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PubMed Identifier

2675713

Citation

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.

Results Reference

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PubMed Identifier

26238641

Citation

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.

Results Reference

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PubMed Identifier

27942208

Citation

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.

Results Reference

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Citation

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.

Results Reference

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PubMed Identifier

7154893

Citation

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

Results Reference

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PubMed Identifier

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Citation

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.

Results Reference

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PubMed Identifier

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Citation

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.

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PubMed Identifier

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Citation

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.

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PubMed Identifier

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Citation

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.

Results Reference

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PubMed Identifier

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Citation

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.

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

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