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Cardiovascular Rehabilitation and Reeducation (CVRR) in Patients With Cardiac Pathologies and the 6-minute Stepper Test (STEPPER)

Primary Purpose

Cardiac Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
6 minutes step test (ST6)
Sponsored by
Lille Catholic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cardiac Disease focused on measuring Cardiovascular rehabilitation, Stepper test, 6-minute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,
  • Severe pulmonary arterial hypertension,
  • Oxygen therapy,
  • Musculoskeletal or balance problems that would limit the ability to do any of the following the fiscal year.
  • Pregnant or breastfeeding women,
  • Incapacity to consent (including persons under guardianship or curatorship)

Sites / Locations

  • Clinique de la Mitterie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cardiovascular disease

Arm Description

Outcomes

Primary Outcome Measures

Internal validity of the 6 minutes step test (ST6)
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)
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
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.
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
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.

Full Information

First Posted
January 6, 2021
Last Updated
November 28, 2022
Sponsor
Lille Catholic University
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1. Study Identification

Unique Protocol Identification Number
NCT04699136
Brief Title
Cardiovascular Rehabilitation and Reeducation (CVRR) in Patients With Cardiac Pathologies and the 6-minute Stepper Test
Acronym
STEPPER
Official Title
Use and Validation of the 6-minute Stepper Test in in Patients With Cardiac Pathologies Needing Rehabilitation and Reeducation (CVRR)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 13, 2021 (Actual)
Primary Completion Date
April 28, 2022 (Actual)
Study Completion Date
April 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lille Catholic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Disease
Keywords
Cardiovascular rehabilitation, Stepper test, 6-minute

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cardiovascular disease
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
6 minutes step test (ST6)
Intervention Description
Performing a 6 minutes step test at different intervals and comparing with respect with the 6 minutes walk test and cardiac stress test
Primary Outcome Measure Information:
Title
Internal validity of the 6 minutes step test (ST6)
Description
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.
Time Frame
Day 0
Title
External validity of the ST6 with respect to the 6 minutes walk test (WT6)
Description
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.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
External validity of the ST6 with respect to the cardiac stress test
Description
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.
Time Frame
Day 0
Title
External validity of the ST6 with respect to the Oxygen saturation at rest.
Description
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.
Time Frame
Day 0
Title
External validity of the ST6 with respect to the heart rate at maximum effort
Description
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.
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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, Severe pulmonary arterial hypertension, Oxygen therapy, Musculoskeletal or balance problems that would limit the ability to do any of the following the fiscal year. Pregnant or breastfeeding women, Incapacity to consent (including persons under guardianship or curatorship)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amandine SECQ, MD
Organizational Affiliation
Clinique de la Mitterie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique de la Mitterie
City
Lille
ZIP/Postal Code
59160
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cardiovascular Rehabilitation and Reeducation (CVRR) in Patients With Cardiac Pathologies and the 6-minute Stepper Test

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