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

NCT ID: NCT03491423

Last Updated: 2019-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-04
• Study Completion Date: 2019-05-03

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.

Conditions

Coronary Artery Disease Without Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients

Group Type: EXPERIMENTAL

Short and fast step test without measurement of pulmonary gas exchange

Intervention Type: OTHER

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

Intervention Type: BIOLOGICAL

glucose meter to measure lactatemia

ECG / heart rate

Intervention Type: OTHER

ECG and heart rate (HR) collection by telemetry

questionnaires

Intervention Type: OTHER

VAS pain assessment and evaluation of effort perception according to Borg's scale

Short and fast step test with measurement of pulmonary gas exchange

Intervention Type: OTHER

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.

Interventions

Short and fast step test without measurement of pulmonary gas exchange

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: OTHER

glucose meter

glucose meter to measure lactatemia

Intervention Type: BIOLOGICAL

ECG / heart rate

ECG and heart rate (HR) collection by telemetry

Intervention Type: OTHER

questionnaires

VAS pain assessment and evaluation of effort perception according to Borg's scale

Intervention Type: OTHER

Short and fast step test with measurement of pulmonary gas exchange

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: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de DIJON

Dijon, , France

Countries

France

Other Identifiers

HANNEQUIN APPARA 2016

Identifier Type: -

Identifier Source: org_study_id