- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03491423
Short and Fast Step Test: Feasibility, Validity and Tolerance of a Functional Evaluation Test of Lactic Anaerobic Capacities in Patients With Coronary Artery Disease (CORANAE)
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Dijon, France, 21079
- CHU de Dijon
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients
|
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.
glucose meter to measure lactatemia
ECG and heart rate (HR) collection by telemetry
VAS pain assessment and evaluation of effort perception according to Borg's scale
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
percentage of patients who completed the SFST without complications
Time Frame: through study completion, an average of 11 days
|
- 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:
|
through study completion, an average of 11 days
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Diagnostic Techniques and Procedures
- Diagnosis
- Circulatory and Respiratory Physiological Phenomena
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Physical Examination
- Vital Signs
- Hemodynamics
- Cardiovascular Physiological Phenomena
- Surveys and Questionnaires
- Heart Rate
- epicatechin gallate
Other Study ID Numbers
- HANNEQUIN APPARA 2016
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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