Innovative Care Pathway in Physical Activity and Behavior Change in Coronary Patients Post-cardiac Rehabilitation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorElsan
About this trial
The objective of this 18-month research is to show the effectiveness of an individualized physical activity( PA) compared to standard PA management and voluntary PA, to achieve a change in the behavior of the coronary patient.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Post-infarction coronary artery patient aged 18 years and older, with no gender difference.
Patients engaged in a follow-up care and cardiovascular rehabilitation program at the Supervaltech center.
Patient at low to moderate RARE risk of complication (RARE score 2 to 3)
Patients equipped with smartphones, laptops or other equipment compatible with downloading an application with their personal ID
Disqualifiers
Patients with a formal contraindication to physical activity such as: unstabilized coronary syndrome, decompensated heart failure, severe ventricular arrhythmias, intracardiac thrombus at risk embolic, PAH, moderate pericardial effusion, history of thrombophlebitis with or without pulmonary embolism, severe and/or symptomatic left ventricular ejection obstruction.
Patients with ongoing infectious disease
Participant whose physical and/or psychological health is severely impaired, which in the opinion of the investigator may affect the study participant's compliance.
Participant included in other research
Trial design
Design model
Parallel
Treatments tested in this trial
Individuals activity programs
Other interventionactivity program will be adjusted every week by practitioner for each patient following data coming from the wearable device ( connected whatch and bellt for 12 months)
activity program
Other interventionpre established program without adjustement. The patient has connected whatch and bellt for 12 months
no Physical Activity program
Other interventionno Physical Activity (PA)program but just PA recommendations.PA is carried out independently (common practice).The patient has connected whatch and bellt for 12 months
Treatment groups
192 Participants
are divided into 3 treatment groupsGroup A: Individualized physical activity programExperimental treatment 1 intervention
Group B: Physical Activity program defined without optimisationActive comparator 1 intervention
Group C: no Physical Activity programOther 1 intervention
Trial outcomes
Primary outcomes
1
6 minutes walk test
patient behaviour change measured with the six minute walk test distance
Time frame
18 monthsLocations
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: