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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03491423
Recruitment Status : Completed
First Posted : April 9, 2018
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Without Heart Failure 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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : June 4, 2018
Actual Primary Completion Date : May 3, 2019
Actual Study Completion Date : May 3, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patients Other: 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.

Biological: glucose meter
glucose meter to measure lactatemia

Other: ECG / heart rate
ECG and heart rate (HR) collection by telemetry

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

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.




Primary Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491423


Locations
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France
CHU de DIJON
Dijon, France, 21079
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03491423    
Other Study ID Numbers: HANNEQUIN APPARA 2016
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases