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

Not Applicable

• Conditions: COPD; Chronic Respiratory Disease
• Interventions: Diagnostic Test: Three-min Step Test and Exercise desaturation detection in COPD

• Registration Number: NCT04911764
• Lead Sponsor: University Hospital, Limoges

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.

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-20
• Study First Submitted QC: 2021-05-27
• Last Update Submitted: 2021-05-27
• Study Start: 2021-06
• Study First Posted: 2021-06-03
• Last Update Posted: 2021-06-03
• Primary Completion: 2022-09
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Detection of exercise desaturation occurrence	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.

Secondary Outcome Measures

Name	Time	Method
Ventilatory output (VE)	At Visit 2: between Day 3 and Day 15 after Visit 1	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.
CO2 production (VCO2)	At Visit 2: between Day 3 and Day 15 after Visit 1	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.
Muscle deoxygenation (delta HHb)	At Visit 2: between Day 3 and Day 15 after Visit 1	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
Patient-perceived sensation of dyspnea	At Visit 2: between Day 3 and Day 15 after Visit 1	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	At Visit 2: between Day 3 and Day 15 after Visit 1	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.
Heart rate (HR)	At Visit 2: between Day 3 and Day 15 after Visit 1	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.
Oxygen consumption (VO2)	At Visit 2: between Day 3 and Day 15 after Visit 1	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.