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

Cardiac Disease Clinical Trial

— STEPPER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04699136
• Other study ID #: RC-P0087
• Secondary ID: 2019-A02483-54
• Status: Completed
• Phase: N/A
• Start date: January 13, 2021
• Est. completion date: April 28, 2022

Study information

• Verified date: November 2022
• Source: Lille Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 28, 2022
• Est. primary completion date: April 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Intervention

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

Locations

Country	Name	City	State
France	Clinique de la Mitterie	Lille

Sponsors (1)

Lead Sponsor	Collaborator
Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0
Primary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0
Secondary	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.	Day 0