Acute Coronary SyndromePROPIUNCT06107452
Customization of Cardiac Readaptation Based on Force-velocity Profile and Heart Rate Variability
A study testing training strategy with adaptation of training strategies to the ANS and training strategy (standard practice) in people with Acute Coronary Syndrome, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Cardiac readaptation aims to mitigate cardiovascular risks and enhance the quality of life among coronary patients. Our research laboratory has an international expertise in training optimization in top-athletes and a previous study has demonstrated the efficacy of optimizing cardiac rehabilitation through the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- training strategy with adaptation of training strategies to the ANS and training strategy (standard practice)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteFrance
- Study dates
- 5 Feb 2024to 27 Oct 2025
- 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
- >18
- Acute Coronary Syndrome treated in the last 6 months
- Medical revascularization (angioplasty ± stenting) or surgical (coronary artery bypass)
- Initial CPETt: MPA ≥ 60w in women and ≥80w in men
- French
- Informed consent
Who cannot join
- Significant co-morbidities limited practice of physical activity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Customization of Cardiac Readaptation Based on Force-velocity Profile and Heart Rate Variability: A Controlled and Randomized Study
Cardiac readaptation aims to mitigate cardiovascular risks and enhance the quality of life among coronary patients. Our research laboratory has an international expertise in training optimization in top-athletes and a previous study has demonstrated the efficacy of optimizing cardiac rehabilitation through the power-force-velocity profile (PFVP). The findings exhibited significant improvements in aerobic capacity, muscular strength, and cardiovascular parameters among patients who were trained based on their PFVP. Guided training utilizing heart rate variability (HRV) is also garnering increasing interest as a means to optimize training load and promote recovery
Read the detailed description
Our study aims to evaluate the application of HRV in regulating training load based on fatigue levels in cardiac rehabilitation patients utilizing the PFVP framework.
- Conditions
- Acute Coronary Syndrome
- Being tested
- training strategy with adaptation of training strategies to the ANS, training strategy (standard practice)
- Keywords
- Cardiac rehabilitation, Physical activity, Force-velocity profile, Autonomic nervous system, Coronary artery disease
- Medical subject headings
- Acute Coronary Syndrome, Motor Activity, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
training strategy with adaptation of training strategies to the ANSOther
a training strategy for subjects whose PFVP is in favour of strength or speed with training load adjusted according to SNA
training strategy (standard practice)Other
a training strategy for subjects whose PFVP is in favour of strength or speed
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patient with acute coronary syndrome will be included. According to their initial strength-speed profile, coronary patients will benefit from an individualized cardiac rehabilitation program, with strength or speed training adapted to the autonomic nervous system (ANS). Receives: Other: training strategy with adaptation of training strategies to the ANS |
| Control group | Active comparator | Patient with acute coronary syndrome will be included. According to their initial force-velocity profile, coronary patients will have an individualized cardiac rehabilitation program, either with a training in force or in velocity. Receives: Other: training strategy (standard practice) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The root mean square of successive differences in heart rate or RMSSD
The root mean square of successive differences in heart rate or RMSSD will be measured from a nocturnal Holter ECG recording at the end of 8 weeks of exercise retraining and compared with the initial pre-training value. weeks of exercise re-training and compared with the initial pre-training value.
Measured: Baseline to 2 months
Secondary outcomes (10)
Value of maximum oxygen consumption
VO2 max (ml/min/kg) thanks to 24-hour ECG recording
Measured: Baseline to 2 months
Assessment of the ANS sympathetic branch
Assessment of the ANS sympathetic branch thanks to SDNN index value
Measured: Baseline to 2 months
Assessment of the ANS parasympathetic branch
Assessment of the ANS parasympathetic branch thanks to RMSSSD index value
Measured: Baseline to 2 months
non-invasive measurement of arterial stiffness
value of pulse wave propagation velocity
Measured: Baseline to 2 months
measurement of upper and lower limb muscle strength
it's a composite outcome :
- measurement of handgrip (kg) thanks to Jamar hydraulic hand dynamometer
- measurement maximum quadriceps strength (kg) thanks to Contrex, Physiomed
Measured: Baseline to 2 months
assessment of PFVP evolution
assessment of PFVP evolution thaks to cycloergometer sprint (Monark, Vansbro)
Measured: Baseline to 2 months
assessment of physical a activity and sedentary behavior
it's a composite outcome :
- assessment of physical a activity and sedentary behavior thanks to actimetry (Actigraph GT9x)
- assessment of physical a activity and sedentary behavior thanks to Adult Physical Activity Questionnaire (APAQ)
Measured: Baseline to 2 months
quality of life assessment
it's a composite outcome :
- with mental quality of life score
- with physical quality of life score
Measured: Baseline to 2 months
assessment of subjective fatigue
assessment of subjective fatigue thanks to FACIT-F questionary
Measured: Baseline to 2 months
biological data
it's a composite outcome : complete blood biology and relevant inflammatory biomarkers involved in cardiac rehabilitation.
Measured: Baseline to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start5 Feb 2024
- Primary completion12 Sep 2025
- Study completion27 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David HUPIN, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107452
- Sponsor's protocol ID
- 23CH152
- Other IDs
- 2023-A01452-43
- Acronym
- PROPIU
- Status last verified
- Sep 2026
- First submitted
- 11 Oct 2023
- Last updated
- 17 Sep 2026
- 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 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Customization of Cardiac Readaptation Based on Force-velocity Profile and Heart Rate Variability: A Controlled and Randomized Study
- ClinicalTrials.gov ID
- NCT06107452
- Acronym / sponsor ID
- PROPIU / 23CH152
- Conditions
- Acute Coronary Syndrome
- Keywords
- Cardiac rehabilitation, Physical activity, Force-velocity profile, Autonomic nervous system, Coronary artery disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 12 Sep 2025 (actual)
- Study completion
- 27 Oct 2025 (actual)
- First posted
- 30 Oct 2023 (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.
Cardiac readaptation aims to mitigate cardiovascular risks and enhance the quality of life among coronary patients. Our research laboratory has an international expertise in training optimization in top-athletes and a previous study has demonstrated the efficacy of optimizing cardiac rehabilitation through the power-force-velocity profile (PFVP). The findings exhibited significant improvements in aerobic capacity, muscular strength, and cardiovascular parameters among patients who were trained based on their PFVP. Guided training utilizing heart rate variability (HRV) is also garnering increasing interest as a means to optimize training load and promote recovery
Detailed description
Our study aims to evaluate the application of HRV in regulating training load based on fatigue levels in cardiac rehabilitation patients utilizing the PFVP framework.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: training strategy with adaptation of training strategies to the ANSPatient with acute coronary syndrome will be included. According to their initial strength-speed profile, coronary patients will benefit from an individualized cardiac rehabilitation program, with strength or speed training adapted to the autonomic nervous system (ANS). |
| Control group | Active comparator | Other: training strategy (standard practice)Patient with acute coronary syndrome will be included. According to their initial force-velocity profile, coronary patients will have an individualized cardiac rehabilitation program, either with a training in force or in velocity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- >18
- Acute Coronary Syndrome treated in the last 6 months
- Medical revascularization (angioplasty ± stenting) or surgical (coronary artery bypass)
- Initial CPETt: MPA ≥ 60w in women and ≥80w in men
- French
Key exclusion criteria (1 listed)
- Significant co-morbidities limited practice of physical activity
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 |
|---|---|---|
| training strategy with adaptation of training strategies to the ANSa training strategy for subjects whose PFVP is in favour of strength or speed with training load adjusted according to SNA | Other | Experimental group |
| training strategy (standard practice)a training strategy for subjects whose PFVP is in favour of strength or speed | Other | Control group |
Primary outcome
The root mean square of successive differences in heart rate or RMSSD
Time frame: Baseline to 2 months
The root mean square of successive differences in heart rate or RMSSD will be measured from a nocturnal Holter ECG recording at the end of 8 weeks of exercise retraining and compared with the initial pre-training value. weeks of exercise re-training and compared with the initial pre-training value.
10 secondary outcomes
Value of maximum oxygen consumption
Time frame: Baseline to 2 months
Assessment of the ANS sympathetic branch
Time frame: Baseline to 2 months
Assessment of the ANS parasympathetic branch
Time frame: Baseline to 2 months
non-invasive measurement of arterial stiffness
Time frame: Baseline to 2 months
measurement of upper and lower limb muscle strength
Time frame: Baseline to 2 months
assessment of PFVP evolution
Time frame: Baseline to 2 months
assessment of physical a activity and sedentary behavior
Time frame: Baseline to 2 months
quality of life assessment
Time frame: Baseline to 2 months
assessment of subjective fatigue
Time frame: Baseline to 2 months
biological data
Time frame: Baseline to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- 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.
David HUPIN, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing training strategy with adaptation of training strategies to the ANS and training strategy (standard practice) in people with Acute Coronary Syndrome, run by Centre Hospitalier Universitaire de Saint Etienne 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 6 inclusion and 1 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: finished, as of the sponsor's last update on 17 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The root mean square of successive differences in heart rate or RMSSD (time frame: Baseline to 2 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 17 Sep 2026.