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NCT Number: NCT04911764

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.

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Key information

Conditions

COPD Behavior Chronic Disease Chronic Respiratory Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu de Limoges

Limoges, 87000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Patient-perceived sensation of dyspnea

    Time frame: 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.

  2. Patient-perceived sensation of lower extremity fatigue

    Time frame: 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.

  3. Oxygen consumption (VO2)

    Time frame: 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.

  4. CO2 production (VCO2)

    Time frame: 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.

  5. Ventilatory output (VE)

    Time frame: 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.

  6. Heart rate (HR)

    Time frame: 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.

  7. Muscle deoxygenation (delta HHb)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Official study 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

Acronym: STEPSAT

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 3, 2021
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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