STEPPER: Cardiovascular Rehabilitation and Reeducation (CVRR) in Patients With Cardiac Pathologies and the 6-minute Stepper Test
Study Details
Study Description
Brief Summary
The objective is to study the validity of the 6-minute stepper test (ST6) in order to determine tolerance to effort in cardiovascular patients
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The 6-minute stepper test (ST6) is an test used and validated in patients with respiratory disorders (chronic obstructive pulmonary disease) in order to evaluate their tolerance to exercise. It is well tolerated and reproducible in these patients, with the advantage that it can be performed without spatial constraints.
However, this test is not yet used in cardiology. This study proposes to validate the ST6, to evaluate the exercise tolerance of patients suffering from cardiovascular pathologies.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Cardiovascular disease
|
Other: 6 minutes step test (ST6)
Performing a 6 minutes step test at different intervals and comparing with respect with the 6 minutes walk test and cardiac stress test
|
Outcome Measures
Primary Outcome Measures
- Internal validity of the 6 minutes step test (ST6) [Day 0]
The number of steps taken in 6 minutes with the ST6 will be measured twice on the first day of the cardiovascular rehabilitation and education. The second ST6 will be performed 30 minutes after the first. Internal validity will be studied by calculating the intra-class correlation coefficient (ICC) of the number of steps from the two ST6 carried out and its 95% confidence interval.
- External validity of the ST6 with respect to the 6 minutes walk test (WT6) [Day 0]
The external validity with respect to the (6 minutes walk test) WT6 will be studied by calculating the Pearson correlation coefficient and its 95% confidence interval between the number of steps from the ST6 and the distance travelled in meters from the WT6.
Secondary Outcome Measures
- External validity of the ST6 with respect to the cardiac stress test [Day 0]
The external validity with respect to the cardiac stress test will be studied by calculating the Pearson correlation coefficient and its 95% confidence interval between the number of steps from the ST6 and the cardiac stress test.
- External validity of the ST6 with respect to the Oxygen saturation at rest. [Day 0]
The external validity with respect to the Oxygen saturation at rest will be studied by calculating the Pearson correlation coefficient and its 95% confidence interval between the number of steps from the ST6 and the Oxygen saturation at rest.
- External validity of the ST6 with respect to the heart rate at maximum effort [Day 0]
The external validity with respect to the heart rate at maximum effort will be studied by calculating the Pearson correlation coefficient and its 95% confidence interval between the number of steps from the ST6 and the heart rate.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years old,
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Patient with a cardiac pathology (coronary bypass, valve replacement, heart transplant, coronary angioplasty),
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Registered in Cardiovascular Rehabilitation at the Mitterie Clinic,
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Number of rehabilitation sessions at least equal to 30,
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Ejection fraction ≥ 45%,
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Signed written consent of the patient,
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Affiliation to a social security scheme.
Exclusion Criteria:
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Cardiac decompensation,
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Severe functional limitation,
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Unstable acute coronary syndrome,
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Decompensated heart failure,
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Severe ventricular rhythm disorders,
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Presence of an intracardiac thrombus with high embolic risk,
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Presence of a medium to large pericardial effusion (effusion of more than 10mm circumferential or 14mm localized on ultrasound),
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Recent history (months prior to inclusion) of thrombophlebitis with or without pulmonary embolism,
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Severe and/or symptomatic left ventricular ejection obstruction,
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Any progressive inflammatory and/or infectious disease,
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Severe pulmonary arterial hypertension,
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Oxygen therapy,
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Musculoskeletal or balance problems that would limit the ability to do any of the following the fiscal year.
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Pregnant or breastfeeding women,
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Incapacity to consent (including persons under guardianship or curatorship)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinique de la Mitterie | Lille | France | 59160 |
Sponsors and Collaborators
- Lille Catholic University
Investigators
- Principal Investigator: Amandine SECQ, MD, Clinique de la Mitterie
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RC-P0087
- 2019-A02483-54