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

NCT ID: NCT06345807

Last Updated: 2024-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2026-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Individualised Physical Activity Program Coronary Patient

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

interventional study, randomized in 3 parallel groups, single center,
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Individualized physical activity program

Group Type EXPERIMENTAL

Individuals activity programs

Intervention Type 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)

Physical Activity program defined without optimisation

Group Type ACTIVE_COMPARATOR

activity program

Intervention Type OTHER

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

no Physical Activity program

Group Type OTHER

no Physical Activity program

Intervention Type 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

Interventions

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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)

Intervention Type OTHER

activity program

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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Elsan

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Deva BAS, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique SSR SuperValtech

Central Contacts

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christine Blanc

Role: CONTACT

0468562895

Deva BAS, MD

Role: CONTACT

0468874022

Other Identifiers

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2023-A02617-38

Identifier Type: -

Identifier Source: org_study_id

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