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
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2018
CompletedFirst Posted
Study publicly available on registry
April 9, 2018
CompletedStudy Start
First participant enrolled
June 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 3, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 3, 2019
CompletedFebruary 4, 2026
February 1, 2026
11 months
March 30, 2018
February 2, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
percentage of patients who completed the SFST without complications
\- 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).
through study completion, an average of 11 days
Study Arms (1)
Patients
EXPERIMENTALInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- \- 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%.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de DIJON
Dijon, 21079, France
Related Publications (1)
Besson D, Gouteron A, Sinssaine-Ayillo A, Casillas JM, Rigaud L, Ornetti P, Fournel I, Ksiazek E, Laroche D, Gueugnon M. Is the Short and Fast Step Test a safe and feasible tool for exploring anaerobic capacities of individuals with coronary heart disease in clinical practice? Eur J Phys Rehabil Med. 2021 Dec;57(6):977-984. doi: 10.23736/S1973-9087.21.06713-7. Epub 2021 Feb 23.
PMID: 33619946RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2018
First Posted
April 9, 2018
Study Start
June 4, 2018
Primary Completion
May 3, 2019
Study Completion
May 3, 2019
Last Updated
February 4, 2026
Record last verified: 2026-02