Short and Fast Step Test: Feasibility, Validity and Tolerance of a Functional Evaluation Test of Lactic Anaerobic Capacities in Patients With Coronary Artery Disease

Not Applicable

Completed

• Conditions: Coronary Artery Disease Without Heart Failure
• Interventions: Other: Short and fast step test without measurement of pulmonary gas exchange; Biological: glucose meter; Other: ECG / heart rate; Other: questionnaires; Other: Short and fast step test with measurement of pulmonary gas exchange

• Registration Number: NCT03491423
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-30
• Study First Submitted QC: 2018-04-06
• Study First Posted: 2018-04-09
• Study Start: 2018-06-04
• Primary Completion: 2019-05-03
• Study Completion: 2019-05-03
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-03
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients	glucose meter	-
Patients	Short and fast step test without measurement of pulmonary gas exchange	-
Patients	questionnaires	-
Patients	Short and fast step test with measurement of pulmonary gas exchange	-
Patients	ECG / heart rate	-

Primary Outcome Measures

Name	Time	Method
percentage of patients who completed the SFST without complications	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: * 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).

Trial Locations

Locations (1)

CHU de DIJON; 🇫🇷 Dijon, France