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Completed

NCT Number: 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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de DIJON

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Short and fast step test without measurement of pulmonary gas exchange

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

Biological

glucose meter to measure lactatemia

ECG / heart rate

Other

ECG and heart rate (HR) collection by telemetry

questionnaires

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

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.

Primary outcomes

  1. 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:

    • 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).

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: CORANAE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 9, 2018
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.