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Clinical Trials/NCT04699136
NCT04699136
Completed
Not Applicable

Use and Validation of the 6-minute Stepper Test in in Patients With Cardiac Pathologies Needing Rehabilitation and Reeducation (CVRR)

Lille Catholic University1 site in 1 country60 target enrollmentJanuary 13, 2021
ConditionsCardiac Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiac Disease
Sponsor
Lille Catholic University
Enrollment
60
Locations
1
Primary Endpoint
Internal validity of the 6 minutes step test (ST6)
Status
Completed
Last Updated
4 months ago

Overview

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

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.

Registry
clinicaltrials.gov
Start Date
January 13, 2021
End Date
April 28, 2022
Last Updated
4 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Lille Catholic University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age ≥ 18 years old,
  • Patient with a cardiac pathology (coronary bypass, valve replacement, heart transplant, coronary angioplasty),
  • Registered in Cardiovascular Rehabilitation at the Mitterie Clinic,
  • Number of rehabilitation sessions at least equal to 30,
  • Ejection fraction ≥ 45%,
  • Signed written consent of the patient,
  • Affiliation to a social security scheme.

Exclusion Criteria

  • Cardiac decompensation,
  • Severe functional limitation,
  • Unstable acute coronary syndrome,
  • Decompensated heart failure,
  • Severe ventricular rhythm disorders,
  • Presence of an intracardiac thrombus with high embolic risk,
  • Presence of a medium to large pericardial effusion (effusion of more than 10mm circumferential or 14mm localized on ultrasound),
  • Recent history (months prior to inclusion) of thrombophlebitis with or without pulmonary embolism,
  • Severe and/or symptomatic left ventricular ejection obstruction,
  • Any progressive inflammatory and/or infectious disease,

Outcomes

Primary Outcomes

Internal validity of the 6 minutes step test (ST6)

Time Frame: 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)

Time Frame: 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 Outcomes

  • External validity of the ST6 with respect to the cardiac stress test(Day 0)
  • External validity of the ST6 with respect to the Oxygen saturation at rest.(Day 0)
  • External validity of the ST6 with respect to the heart rate at maximum effort(Day 0)

Study Sites (1)

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