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

NCT06345807 | Not Yet Recruiting

• 1 other identifier: 2023-A02617-38
• Study Type: interventional
• Target: 192
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Individualised Physical Activity Program; Coronary Patient

Keywords

cardiac rehabilitation; ischemic heart disease; physical activity; wearables

Outcome Measures

Primary Outcomes (1)

• 6 minutes walk test

  patient behaviour change measured with the six minute walk test distance

  18 months

Study Arms (3)

Individualized physical activity program

EXPERIMENTAL

Other: Individuals activity programs

Physical Activity program defined without optimisation

ACTIVE COMPARATOR

Other: activity program

no Physical Activity program

OTHER

Other: no Physical Activity program

Interventions

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)

Individualized physical activity program

activity program OTHER

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

Physical Activity program defined without optimisation

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

no Physical Activity program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Elsan: lead

MeSH Terms

Conditions

Myocardial Ischemia; Motor Activity

Interventions

Commission on Professional and Hospital Activities

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Medical Audit; Clinical Audit; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Deva BAS, MD

  Clinique SSR SuperValtech

  PRINCIPAL INVESTIGATOR

Central Study Contacts

christine Blanc

CONTACT

0468562895; christine.blanc@elsan.care

Deva BAS, MD

CONTACT

0468874022

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: interventional study, randomized in 3 parallel groups, single center,

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 3, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share