Myocardial InfarctionHRV REEDUCNCT03745742
Post Myocardial Infarction's Rehabilitation Guided by Heart Rate Variability
A study testing HRV measurement in people with Myocardial Infarction and Cardiac Rehabilitation, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Cardiac rehabilitation reduces morbidity and mortality after myocardial infarction (MI) and improve the sympathovagal balance. The autonomic nervous system (ANS) can be explored by the variation of heart rate (HRV). The HRV is a fatigue marker and guides the athletes training programs. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Myocardial Infarction, Cardiac Rehabilitation
- What is being tested?
- HRV measurement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2016to 30 Sep 2017
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man, Woman ≥18 years old and <70 years old
- STEMI or NSTEMI having undergone angioplasty revascularization at least 8 day before the beginning of reeducation
- Sinus rhythm
- LVEF> 40% (Simpson Biplane echocardiography
Who cannot join
- Contraindications to cardiac re-training:
- Ventricular or supraventricular rhythm disorder
- Heart failure.
- Pericardial effusion.
- STEMI or NSTEMI <J8
- NSTEMI or STEMI , post revascularization by bypass surgery
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- Non-sinus rhythm
- Comorbidity preventing all sports activity: severe AOMI; amputation; neurological disorder, hemiplegia.
- Pathology leading to modifications of the HRV:
- Chronic lung disease
- Renal insufficiency with clearance <30 ml / min (MDRD)
- LVEF <40%
- Electrical cardiac stimulation
- Linked to the person:
- Protected Majors
- People unable to express their consent.
- Pregnant woman
Trial locations and contacts
1 site in 1 country.
About this study
Cardiac rehabilitation reduces morbidity and mortality after myocardial infarction (MI) and improve the sympathovagal balance. The autonomic nervous system (ANS) can be explored by the variation of heart rate (HRV). The HRV is a fatigue marker and guides the athletes training programs. A smartphone app can measure the HRV via a heart rate monitor.
The main study objective is to compare the effect on the functional capacities of a re-training adapted to the HRV compared to a standard program in the post-MI The secondary objective is to compare the patients' quality of life according to the rehabilitation program and to validate the HRV smartphone app.
This is a prospective, multicenter study. Post-MI patients treated with angioplasty with a LVEF> 40% are randomized into 2 groups: HRV (re-training adapted to HRV daily: 10W decrease or increase in workload according to the HRV) or control (continuous training in SV1). Patients underwent a cardiopulmonary test, a walking test (TM6) and a SF36 questionaries' at the entrance and exit. The taking of HRV was done every morning in a standardized way via the smartphone app during the 20 re-training sessions.
Read the detailed description
Description of the study:
Patients with myocardial infarction (STEMI or NSTEMI) without alteration of left ventricle systolic function, agreeing to participate at a cardiac rehabilitation program will be included in the study and randomized into two groups:
- Group A (= control): standard rehabilitation protocol according to the personal functional capacities (measured by a cardiopulmonary test on the beginning of the cardiac reeducation.)
- Group B (= strategy to the study): individualization of the rehabilitation program according to the daily HRV measure and the personal functional capacity (measured by a cardiopulmonary test on the program beginning).
The duration of the rehabilitation program will be 4 weeks with 5 training sessions per week (Monday to Friday), or 20 training sessions. At the end of the program, patients will benefit from an assessment of functional abilities and their quality of life.
- Conditions
- Myocardial Infarction, Cardiac Rehabilitation
- Being tested
- HRV measurement
- Keywords
- Cardiac rehabilitation, myocardial infarction, heart rate variability, physical fitness
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRV measurementOther
Also called Rehabilitation program based on HRV measurement
Patients in group A (control) will benefit from a standard re-training protocol based on initial functional abilities. The training is done at a target heart rate corresponding to the heart rate reached at the first ventilatory threshold (about 55% of VO2max).
- Patients in group B (study strategy) will benefit from a re-training protocol based on HRV and initial functional abilities. Any increase in HRV compared to the previous day will result in an increase in workload of 10Watt. Any increase or decrease in HRV for 3 days in a row will cause the stagnation of the workload for 2 days.
HRV is measured every day in each group via a heart rate belt and a smartphone App.
| Study group | Role | What they receive |
|---|---|---|
| control | Other | standard rehabilitation protocol according to the personal functional capacities (measured by a cardiopulmonary test on the beginning of the cardiac reeducation. Receives: Other: HRV measurement |
| study strategy | Experimental | individualization of the rehabilitation program according to the daily HRV measure and the personal functional capacity (measured by a cardiopulmonary test on the program beginning). Receives: Other: HRV measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
gain of VO2max
The gain obtained after 4 weeks of cardiac rehabilitation(expressed as% basal value) of VO2max
Measured: after 4 weeks of cardiac rehabilitation
Secondary outcomes (2)
patients'quality of life after 4 weeks of cardiac rehabilitation
The taking of HRV was done every morning in a standardized way via the smartphone app during the 20 re-training sessions.
Measured: after 4 weeks of cardiac rehabilitation
The patient's functional capacity after 4 weeks of cardiac rehabilitation estimated by the distance covered during the 6-minute walk test.
The gain in meter at the 6 minutes' walk test
Measured: after 4 weeks of cardiac rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start1 Mar 2016
- Primary completion31 Aug 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Of Medical Cardio Pneumologie, Durtol, Almerys
- Responsible party
- Sponsor
- Investigators
- D'Agrosa Boiteux Marie-Claire, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745742
- Sponsor's protocol ID
- CHU-417
- Other IDs
- 2015-AO1755-44
- Acronym
- HRV REEDUC
- Status last verified
- Nov 2018
- First submitted
- 15 Nov 2018
- Last updated
- 26 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Myocardial Infarction's Rehabilitation Guided by Heart Rate Variability
- ClinicalTrials.gov ID
- NCT03745742
- Acronym / sponsor ID
- HRV REEDUC / CHU-417
- Conditions
- Myocardial Infarction, Cardiac Rehabilitation
- Keywords
- Cardiac rehabilitation, myocardial infarction, heart rate variability, physical fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Clinical Of Medical Cardio Pneumologie, Durtol, Almerys
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 19 Nov 2018 (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 rehabilitation reduces morbidity and mortality after myocardial infarction (MI) and improve the sympathovagal balance. The autonomic nervous system (ANS) can be explored by the variation of heart rate (HRV). The HRV is a fatigue marker and guides the athletes training programs. A smartphone app can measure the HRV via a heart rate monitor.
The main study objective is to compare the effect on the functional capacities of a re-training adapted to the HRV compared to a standard program in the post-MI The secondary objective is to compare the patients' quality of life according to the rehabilitation program and to validate the HRV smartphone app.
This is a prospective, multicenter study. Post-MI patients treated with angioplasty with a LVEF> 40% are randomized into 2 groups: HRV (re-training adapted to HRV daily: 10W decrease or increase in workload according to the HRV) or control (continuous training in SV1). Patients underwent a cardiopulmonary test, a walking test (TM6) and a SF36 questionaries' at the entrance and exit. The taking of HRV was done every morning in a standardized way via the smartphone app during the 20 re-training sessions.
Detailed description
Description of the study:
Patients with myocardial infarction (STEMI or NSTEMI) without alteration of left ventricle systolic function, agreeing to participate at a cardiac rehabilitation program will be included in the study and randomized into two groups:
- Group A (= control): standard rehabilitation protocol according to the personal functional capacities (measured by a cardiopulmonary test on the beginning of the cardiac reeducation.)
- Group B (= strategy to the study): individualization of the rehabilitation program according to the daily HRV measure and the personal functional capacity (measured by a cardiopulmonary test on the program beginning).
The duration of the rehabilitation program will be 4 weeks with 5 training sessions per week (Monday to Friday), or 20 training sessions. At the end of the program, patients will benefit from an assessment of functional abilities and their quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Other | Other: HRV measurementstandard rehabilitation protocol according to the personal functional capacities (measured by a cardiopulmonary test on the beginning of the cardiac reeducation. |
| study strategy | Experimental | Other: HRV measurementindividualization of the rehabilitation program according to the daily HRV measure and the personal functional capacity (measured by a cardiopulmonary test on the program beginning). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Man, Woman ≥18 years old and <70 years old
- STEMI or NSTEMI having undergone angioplasty revascularization at least 8 day before the beginning of reeducation
- Sinus rhythm
- LVEF> 40% (Simpson Biplane echocardiography
Key exclusion criteria (17 listed)
- Contraindications to cardiac re-training:
- Ventricular or supraventricular rhythm disorder
- Heart failure.
- Pericardial effusion.
- STEMI or NSTEMI <J8
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 |
|---|---|---|
| HRV measurementAlso: Rehabilitation program based on HRV measurementPatients in group A (control) will benefit from a standard re-training protocol based on initial functional abilities. The training is done at a target heart rate corresponding to the heart rate reached at the first ventilatory threshold (about 55% of VO2max). * Patients in group B (study strategy) will benefit from a re-training protocol based on HRV and initial functional abilities. Any increase in HRV compared to the previous day will result in an increase in workload of 10Watt. Any increase or decrease in HRV for 3 days in a row will cause the stagnation of the workload for 2 days. HRV is measured every day in each group via a heart rate belt and a smartphone App. | Other | control, study strategy |
Primary outcome
gain of VO2max
Time frame: after 4 weeks of cardiac rehabilitation
The gain obtained after 4 weeks of cardiac rehabilitation(expressed as% basal value) of VO2max
2 secondary outcomes
patients'quality of life after 4 weeks of cardiac rehabilitation
Time frame: after 4 weeks of cardiac rehabilitation
The patient's functional capacity after 4 weeks of cardiac rehabilitation estimated by the distance covered during the 6-minute walk test.
Time frame: after 4 weeks of cardiac rehabilitation
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 26 Nov 2018.
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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.
D'Agrosa Boiteux Marie-Claire principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HRV measurement in people with Myocardial Infarction and Cardiac Rehabilitation, run by University Hospital, Clermont-Ferrand 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 17 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 26 Nov 2018. 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?
gain of VO2max (time frame: after 4 weeks of cardiac rehabilitation). 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 26 Nov 2018.