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Clinical Trials/NCT06345807
NCT06345807
Not Yet Recruiting
N/A

Innovative Care Pathway in Physical Activity and Behavior Change in Coronary Patients Post Cardiac Rehabilitation

Elsan0 sites192 target enrollmentMay 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Individualised Physical Activity Program
Sponsor
Elsan
Enrollment
192
Primary Endpoint
6 minutes walk test
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 2024
End Date
November 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Elsan
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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
  • Patient able to understand French for the purpose of conducting the study.
  • Affiliated member or beneficiary of a social security scheme.
  • Participant who has been informed and has given free, informed and written consent (no later than the day of inclusion and before any examination required by the research).

Exclusion Criteria

  • 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
  • Participant in a period of exclusion from another research still in progress at the time of inclusion.
  • Protected participant: an adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
  • Pregnant, breastfeeding or parturient women.
  • Participant hospitalized without consent.

Outcomes

Primary Outcomes

6 minutes walk test

Time Frame: 18 months

patient behaviour change measured with the six minute walk test distance

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