Back to resultsShort and Fast Step Test: Feasibility, Validity and Tolerance of a Functional Evaluation Test of Lactic Anaerobic Capacities in Patients With Coronary Artery Disease (CORANAE)
Primary Purpose
Coronary Artery Disease Without Heart Failure
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Short and fast step test without measurement of pulmonary gas exchange
glucose meter
ECG / heart rate
questionnaires
Short and fast step test with measurement of pulmonary gas exchange
Sponsored by
About this trial
This is an interventional other trial for Coronary Artery Disease Without Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Patient who has given oral consent Adult patient (male or female) with coronary artery disease without heart failure referred for rehabilitation program Left ventricular ejection fraction (Simpson method) > 45%.
Exclusion Criteria:
- Protected adult
- Patient not affiliated to a national health insurance scheme
- Pregnant or breastfeeding woman
- Orthostatic hypotension
- Severe obstructive heart disease
- aortic valve narrowing
- Progressive severe cardiac rhythm or conduction disorders not requiring a device, detected during the initial stress test.
- intracavitary cardiac thrombus
- severe pulmonary arterial hypertension (systolic pulmonary hypertension >70mmHg)
- recent venous thromboembolic history (last 3 months)
- heart transplantation
- associated medical condition that can predominantly impair functional and respiratory capacities (examples: unstabilized metabolic disorders such as progressive renal failure, significant asthenia related to a severe unstabilized condition such as neoplasia, systemic disease, chronic obstructive pulmonary disease...)
- physical impairments of the lower limbs hindering the test, whether neurological (central or peripheral), arterial (in particular, arteriopathy of the lower limbs with systolic index < 0.6) or orthopedic (degenerative or inflammatory rheumatism)
- Treatment with Corticosteroids, Anabolics, or L-Carnitine.
Sites / Locations
- CHU de DIJON
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients
Arm Description
Outcomes
Primary Outcome Measures
percentage of patients who completed the SFST without complications
- Absence of muscular or bone-joint disorders quantified according to the VAS. The exercise will be considered as not tolerated if pain is reported during the test and/or at day 3 (VAS≥6).
AND no falls or stumbling related trauma
AND absence of cardiovascular or blood pressure events:
Hypertension (systolic pressure greater than 250 mmHg (O'Brien et al. 2005) or hypotension with clinical consequences (malaise or feeling unwell)
Discomfort, chest pain, onset of vascular claudication
Rhythm or conduction disorders or repolarization abnormalities, at a higher frequency than that observed in the pre-inclusion stress test
Abnormal increase in heart rate (greater than the maximum rate determined during the stress test).
Secondary Outcome Measures
Full Information
NCT ID
NCT03491423
First Posted
March 30, 2018
Last Updated
September 3, 2019
Sponsor
Centre Hospitalier Universitaire Dijon
1. Study Identification
Unique Protocol Identification Number
NCT03491423
Brief Title
Short and Fast Step Test: Feasibility, Validity and Tolerance of a Functional Evaluation Test of Lactic Anaerobic Capacities in Patients With Coronary Artery Disease
Acronym
CORANAE
Official Title
Short and Fast Step Test: Feasibility, Validity and Tolerance of a Functional Evaluation Test of Lactic Anaerobic Capacities in Patients With Coronary Artery Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
June 4, 2018 (Actual)
Primary Completion Date
May 3, 2019 (Actual)
Study Completion Date
May 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Recommendations for cardiovascular rehabilitation (CVR) encourage exercise training, primarily involving the aerobic system, to allow patients to regain independence in daily activities. However, the lactic anaerobic process is also involved during these activities (stair climbing, carrying loads, etc.). Hence there is a major interest in accurately assessing patients' anaerobic capacities in order to tailor suitable exercise programs. However, there are no functional tests specifically dedicated to the evaluation of lactic anaerobic metabolism and adapted to people with coronary disease. The investigators offer a dedicated test, the short and fast test (SFST), which can be applied in current clinical practice and has already been evaluated in a population of healthy subjects. The purpose of this project is to evaluate the safety, feasibility and validity of SFST in a population of patients with coronary artery disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease Without Heart Failure
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Short and fast step test without measurement of pulmonary gas exchange
Intervention Description
For one minute, the patient should climb up and down a 17.5 cm high step as quickly as possible while holding onto a bar in front of the step.
Intervention Type
Biological
Intervention Name(s)
glucose meter
Intervention Description
glucose meter to measure lactatemia
Intervention Type
Other
Intervention Name(s)
ECG / heart rate
Intervention Description
ECG and heart rate (HR) collection by telemetry
Intervention Type
Other
Intervention Name(s)
questionnaires
Intervention Description
VAS pain assessment and evaluation of effort perception according to Borg's scale
Intervention Type
Other
Intervention Name(s)
Short and fast step test with measurement of pulmonary gas exchange
Intervention Description
For one minute, the patient should climb up and down a 17.5 cm high step as quickly as possible while holding onto a bar in front of the step.
Primary Outcome Measure Information:
Title
percentage of patients who completed the SFST without complications
Description
- Absence of muscular or bone-joint disorders quantified according to the VAS. The exercise will be considered as not tolerated if pain is reported during the test and/or at day 3 (VAS≥6).
AND no falls or stumbling related trauma
AND absence of cardiovascular or blood pressure events:
Hypertension (systolic pressure greater than 250 mmHg (O'Brien et al. 2005) or hypotension with clinical consequences (malaise or feeling unwell)
Discomfort, chest pain, onset of vascular claudication
Rhythm or conduction disorders or repolarization abnormalities, at a higher frequency than that observed in the pre-inclusion stress test
Abnormal increase in heart rate (greater than the maximum rate determined during the stress test).
Time Frame
through study completion, an average of 11 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- Patient who has given oral consent Adult patient (male or female) with coronary artery disease without heart failure referred for rehabilitation program Left ventricular ejection fraction (Simpson method) > 45%.
Exclusion Criteria:
Protected adult
Patient not affiliated to a national health insurance scheme
Pregnant or breastfeeding woman
Orthostatic hypotension
Severe obstructive heart disease
aortic valve narrowing
Progressive severe cardiac rhythm or conduction disorders not requiring a device, detected during the initial stress test.
intracavitary cardiac thrombus
severe pulmonary arterial hypertension (systolic pulmonary hypertension >70mmHg)
recent venous thromboembolic history (last 3 months)
heart transplantation
associated medical condition that can predominantly impair functional and respiratory capacities (examples: unstabilized metabolic disorders such as progressive renal failure, significant asthenia related to a severe unstabilized condition such as neoplasia, systemic disease, chronic obstructive pulmonary disease...)
physical impairments of the lower limbs hindering the test, whether neurological (central or peripheral), arterial (in particular, arteriopathy of the lower limbs with systolic index < 0.6) or orthopedic (degenerative or inflammatory rheumatism)
Treatment with Corticosteroids, Anabolics, or L-Carnitine.
Facility Information:
Facility Name
CHU de DIJON
City
Dijon
ZIP/Postal Code
21079
Country
France
12. IPD Sharing Statement
Learn more about this trial
Short and Fast Step Test: Feasibility, Validity and Tolerance of a Functional Evaluation Test of Lactic Anaerobic Capacities in Patients With Coronary Artery Disease
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