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

Study Overview
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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.

Official Title
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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

Conditions
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COPD, Chronic Respiratory Disease

Intervention / Treatment
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* Diagnostic Test: Three-min Step Test and Exercise desaturation detection in COPD


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective non-randomized interventional study, with low risks and constraints.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Three-min Step Test and Exercise desaturation detection in COPD<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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 | At Visit 2: between Day 3 and Day 15 after Visit 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Exercise, oxygen desaturation, field tests