NCT03491423

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 9, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

June 4, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2019

Completed
Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

March 30, 2018

Last Update Submit

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

EXPERIMENTAL
Other: Short and fast step test without measurement of pulmonary gas exchangeBiological: glucose meterOther: ECG / heart rateOther: questionnairesOther: Short and fast step test with measurement of pulmonary gas exchange

Interventions

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.

Patients
glucose meterBIOLOGICAL

glucose meter to measure lactatemia

Patients

ECG and heart rate (HR) collection by telemetry

Patients

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

Patients

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.

Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

MeSH Terms

Interventions

epicatechin gallateHeart RateSurveys and Questionnaires

Intervention Hierarchy (Ancestors)

Vital SignsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological PhenomenaData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

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

Locations