Individualised Physical Activity ProgramAPICNCT06345807
Innovative Care Pathway in Physical Activity and Behavior Change in Coronary Patients Post-cardiac Rehabilitation
A study testing Individuals activity programs, activity program and no Physical Activity program in people with Individualised Physical Activity Program and Coronary Patient, run by Elsan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Individualised Physical Activity Program, Coronary Patient
- What is being tested?
- Individuals activity programs, activity program and no Physical Activity program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Deva BAS, MD contact
About this study
Official title: 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.
- Being tested
- Individuals activity programs, activity program, no Physical Activity program
- Keywords
- cardiac rehabilitation, ischemic heart disease, physical activity, wearables
- Medical subject headings
- Myocardial Ischemia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individuals activity programsOther
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 programOther
pre established program without adjustement. The patient has connected whatch and bellt for 12 months
no Physical Activity programOther
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
| Study group | Role | What they receive |
|---|---|---|
| Individualized physical activity program | Experimental | Not described Receives: Other: Individuals activity programs |
| Physical Activity program defined without optimisation | Active comparator | Not described Receives: Other: activity program |
| no Physical Activity program | Other | Not described Receives: Other: no Physical Activity program |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minutes walk test
patient behaviour change measured with the six minute walk test distance
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study startOct 2024 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Individualised Physical Activity ProgramStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- interventional study, randomized in 3 parallel groups, single center,
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deva BAS, MD, Principal investigator, Clinique SSR SuperValtech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345807
- Sponsor's protocol ID
- 2023-A02617-38
- Acronym
- APIC
- Status last verified
- Aug 2024
- First submitted
- 28 Mar 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Care Pathway in Physical Activity and Behavior Change in Coronary Patients Post Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT06345807
- Acronym / sponsor ID
- APIC / 2023-A02617-38
- Keywords
- cardiac rehabilitation, ischemic heart disease, physical activity, wearables
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- interventional study, randomized in 3 parallel groups, single center,
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individuals activity programsactivity 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 | Individualized physical activity program |
| activity programpre established program without adjustement. The patient has connected whatch and bellt for 12 months | Other | Physical Activity program defined without optimisation |
| no Physical Activity programno 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 | Other | no Physical Activity program |
Primary outcome
6 minutes walk test
Time frame: 18 months
patient behaviour change measured with the six minute walk test distance
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Deva BAS, MD contact
Deva BAS, MD principal investigator
Clinique SSR SuperValtech
Questions about this trial
What is this clinical trial studying?
A study testing Individuals activity programs, activity program and no Physical Activity program in people with Individualised Physical Activity Program and Coronary Patient, run by Elsan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact christine Blanc (0468562895, christine.blanc@elsan.care), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minutes walk test (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024; AzTrials last refreshed its copy on 3 Nov 2026.