Clinical trial NCT04911764: Three-min Step Test and Exercise Desaturation Detection in Chronic Respiratory Insufficiency Patients
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
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Chronic Respiratory Disease
Keywords: COPD
Exercise
oxygen desaturation
field tests
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2021-06-03
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective non-randomized interventional study, with low risks and constraints.
Primary purpose: DIAGNOSTIC

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.

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)

Primary outcomes:
measure: Detection of exercise desaturation occurrence
timeFrame: At Visit 2: between Day 3 and Day 15 after Visit 1
Secondary outcomes:
measure: Patient-perceived sensation of dyspnea
timeFrame: At Visit 2: between Day 3 and Day 15 after Visit 1
measure: Patient-perceived sensation of lower extremity fatigue
timeFrame: At Visit 2: between Day 3 and Day 15 after Visit 1
measure: Oxygen consumption (VO2)
timeFrame: At Visit 2: between Day 3 and Day 15 after Visit 1
measure: CO2 production (VCO2)
timeFrame: At Visit 2: between Day 3 and Day 15 after Visit 1
measure: Ventilatory output (VE)
timeFrame: At Visit 2: between Day 3 and Day 15 after Visit 1
measure: Heart rate (HR)
timeFrame: At Visit 2: between Day 3 and Day 15 after Visit 1
measure: Muscle deoxygenation (delta HHb)
timeFrame: At Visit 2: between Day 3 and Day 15 after Visit 1
Other outcomes:
Locations:
Study officials:
affiliation: CHU de LIMOGES _ florent.favard@chu-limoges.fr
name: Florent FAVARD, doctor
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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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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.
citation: Takigawa 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.