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NCT Number: NCT06345807

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Individuals activity programs

Other

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)

activity program

Other

pre established program without adjustement. The patient has connected whatch and bellt for 12 months

no Physical Activity program

Other

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 outcomes

  1. 6 minutes walk test

    Time frame: 18 months

    patient behaviour change measured with the six minute walk test distance

Study contacts

Contact information is provided by the study sponsor or research team.

Deva BAS, MD

CONTACT

0468874022

christine Blanc

CONTACT

[email protected]

0468562895

Sponsors and collaborators

Lead sponsor

Elsan

Other

Registry information

Official study title

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

Acronym: APIC

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 3, 2024
Registry last updated
Sep 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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