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Not yet recruiting NCT06345807

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

No phase Interventional Individualised Physical Activity Program Coronary Patient

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Individuals activity programs, activity program, no Physical Activity program.
Who it may be relevant to
Registry conditions: Individualised Physical Activity Program, Coronary Patient. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other Individuals activity programs
    activity 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)
  • Other activity program
    pre established program without adjustement. The patient has connected whatch and bellt for 12 months
  • Other no Physical Activity program
    no 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

Primary outcome measures

  • 6 minutes walk test [Time frame: 18 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06345807 · 2023-A02617-38

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗