Cardiac RehabilitationAPA&CO2NCT05646849
Using a Connected Application to Maintain Physical Activity After Cardiac Rehabilitation
A study testing Connected application in people with Cardiac Rehabilitation and Acute Coronary Syndrome, run by University Hospital, Angers at 1 site in France.
Trial summary
Maintaining physical activity after cardiac rehabilitation has a major role in disease progression and patient prognosis. 6 months after the cardiac rehabilitation, we find during a nursing interview that many patients do not maintain regular physical activity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Rehabilitation, Acute Coronary Syndrome, Heart Failure
- What is being tested?
- Connected application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jan 2023to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patient participating in cardiac rehabilitation
- Patient with a smartphone compatible with the application
- Patient with internet connection
- Patient having signed the written consent to participate
Who cannot join
- Patient reluctant or unable to comply with the protocol
- Pregnant, parturient and nursing mothers
- Persons deprived of their liberty or under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Maintaining physical activity after cardiac rehabilitation has a major role in disease progression and patient prognosis. 6 months after the cardiac rehabilitation, we find during a nursing interview that many patients do not maintain regular physical activity.
1 year after cardiac rehabilitation, between 30% and 60% of patients do not maintain the recommendations in terms of physical activity.
Read more
It is recommended to perform studies evaluating the effectiveness of new technologies in the fight against non-compliance recommendations for physical activity.
That is why, study the interest of using an application connected post-cardiac rehabilitation seems necessary to fight against dropouts in terms of physical activity.
Read the detailed description
The objective is to study compliance with the recommendations, assessed by accelerometer at 6 months post-cardiac rehabilitation within two groups : classic care versus using a connected application.
- Being tested
- Connected application
- Keywords
- Cardiac Rehabilitation, Acute Coronary Syndrome, Heart Failure
- Medical subject headings
- Acute Coronary Syndrome, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connected applicationOther
Recording and sharing sessions. Exchanges and interactions with other patients. Participation in three collective challenges.
| Study group | Role | What they receive |
|---|---|---|
| Classic care | No intervention | Home exercise book, personalized advices and development of an individualized project post-cardiac rehabilitation. |
| Connected application | Experimental | Recording and sharing sessions. Exchanges and interactions with other patients. Participation in three collective challenges. Receives: Other: Connected application |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate an increase in the percentage of patients respecting at 6 months post-cardiac rehabilitation the recommendations in terms of physical activity
accelerometer
Measured: at 6 months
Secondary outcomes (12)
to study within each group the evolution of the level of physical activity between the end of the cardiac rehabilitation.
questionnaires IPAQ
Measured: at 6 months
to study within each group the evolution of the motivation to physical activity between the end of the cardiac rehabilitation.
questionnaire EMAPS
Measured: at 6 months
to study the difference in the level of physical activity at 6 months post-cardiac rehabilitation between the two groups
questionnaires IPAQ
Measured: at 6 months
to study the difference in the motivation to physical activity at 6 months post-cardiac rehabilitation between the two groups
questionnaire EMAPS
Measured: at 6 months
to describe the maintenance of the physical activity of the two groups according to the seasonality following the end of the cardiac rehabilitation (winter, spring, summer, autumn).
accelerometer
Measured: at 6 months
to describe the use of the application in the intervention group
number of recorded sessions
Measured: at 6 months
to describe patient satisfaction in the intervention group
scale 0-10 (min 0 - max 10)
Measured: at 6 months
to describe the frequency of use of patients in the intervention group to be recorded their sessions
scale 0-4 (min 0 - max 4)
Measured: at 6 months
to describe the interactions with other users in the intervention group
scale 0-4 (min 0 -max 4)
Measured: at 6 months
to describe participation in challenges in the intervention group
scale 0-3 (min 0 - max 3)
Measured: at 6 months
to describe the continued use of the application in the intervention group
number of recorded sessions
Measured: at 12 months
to describe the continued use of the application in the intervention group
number of recorded sessions
Measured: at 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start12 Jan 2023
- Primary completion11 Jan 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RehabilitationStudies 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
- Masking
- None (open label)
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Paul Da Ros Vettoretto, Principal investigator, Centre Hospitalier de Cholet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05646849
- Sponsor's protocol ID
- 2022-A01974-39
- Acronym
- APA&CO2
- Status last verified
- Mar 2024
- First submitted
- 21 Nov 2022
- Last updated
- 27 Mar 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 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Connected Application to Maintain Physical Activity After Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT05646849
- Acronym / sponsor ID
- APA&CO2 / 2022-A01974-39
- Keywords
- Cardiac Rehabilitation, Acute Coronary Syndrome, Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 11 Jan 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 12 Dec 2022 (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.
Maintaining physical activity after cardiac rehabilitation has a major role in disease progression and patient prognosis. 6 months after the cardiac rehabilitation, we find during a nursing interview that many patients do not maintain regular physical activity.
1 year after cardiac rehabilitation, between 30% and 60% of patients do not maintain the recommendations in terms of physical activity.
It is recommended to perform studies evaluating the effectiveness of new technologies in the fight against non-compliance recommendations for physical activity.
That is why, study the interest of using an application connected post-cardiac rehabilitation seems necessary to fight against dropouts in terms of physical activity.
Detailed description
The objective is to study compliance with the recommendations, assessed by accelerometer at 6 months post-cardiac rehabilitation within two groups : classic care versus using a connected application.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classic care | No intervention | –Home exercise book, personalized advices and development of an individualized project post-cardiac rehabilitation. |
| Connected application | Experimental | Other: Connected applicationRecording and sharing sessions. Exchanges and interactions with other patients. Participation in three collective challenges. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient participating in cardiac rehabilitation
- Patient with a smartphone compatible with the application
- Patient with internet connection
- Patient having signed the written consent to participate
Key exclusion criteria (3 listed)
- Patient reluctant or unable to comply with the protocol
- Pregnant, parturient and nursing mothers
- Persons deprived of their liberty or under guardianship
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 |
|---|---|---|
| Connected applicationRecording and sharing sessions. Exchanges and interactions with other patients. Participation in three collective challenges. | Other | Connected application |
Primary outcome
To demonstrate an increase in the percentage of patients respecting at 6 months post-cardiac rehabilitation the recommendations in terms of physical activity
Time frame: at 6 months
accelerometer
12 secondary outcomes
to study within each group the evolution of the level of physical activity between the end of the cardiac rehabilitation.
Time frame: at 6 months
to study within each group the evolution of the motivation to physical activity between the end of the cardiac rehabilitation.
Time frame: at 6 months
to study the difference in the level of physical activity at 6 months post-cardiac rehabilitation between the two groups
Time frame: at 6 months
to study the difference in the motivation to physical activity at 6 months post-cardiac rehabilitation between the two groups
Time frame: at 6 months
to describe the maintenance of the physical activity of the two groups according to the seasonality following the end of the cardiac rehabilitation (winter, spring, summer, autumn).
Time frame: at 6 months
to describe the use of the application in the intervention group
Time frame: at 6 months
to describe patient satisfaction in the intervention group
Time frame: at 6 months
to describe the frequency of use of patients in the intervention group to be recorded their sessions
Time frame: at 6 months
to describe the interactions with other users in the intervention group
Time frame: at 6 months
to describe participation in challenges in the intervention group
Time frame: at 6 months
to describe the continued use of the application in the intervention group
Time frame: at 12 months
to describe the continued use of the application in the intervention group
Time frame: at 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Paul Da Ros Vettoretto principal investigator
Centre Hospitalier de Cholet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connected application in people with Cardiac Rehabilitation and Acute Coronary Syndrome, run by University Hospital, Angers at 1 site in France.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie Gaume (+33241496000, unite-recherche-clinique@ch-cholet.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate an increase in the percentage of patients respecting at 6 months post-cardiac rehabilitation the recommendations in terms of physical activity (time frame: at 6 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 27 Mar 2024.