Heart FailureBougeTonCoeurNCT06222762
Effect of Personalized Follow-up in Adapted Physical Activities in Subjects With Chronic Heart Failure.
A study testing Experimental arm in people with Heart Failure, run by University Hospital, Brest at 2 sites in France.
Trial summary
France has one million people with heart failure (HF). Exercise intolerance, characterised by dyspnoea, is the main clinical symptom in HF patients and a key determinant of reduced quality of life. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Experimental arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesFrance
- Study dates
- 13 Feb 2024to 13 Sep 2027
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of stable heart failure with NYHA stage I, II or III
- Participation in a cardiac rehabilitation programme
- Patient agreement
- Patient of legal age
- Patient affiliated to the Social Security
Who cannot join
- Patient refusal
- Minor patients
- Subjects under guardianship or curatorship
- Subjects over 80 years of age at the time of inclusion
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Baptiste Chéhère, PhD contact
France2 sites, 2 recruiting
- Recruiting
Fondation ILDYS
Brest, 29200
Klervie BAILLY, Md, 33298028317, klervie.bailly@ildys.org
- Recruiting
CHU de Brest
Brest, 29609
Jacques MANSOURATI, Md, PhD, 33298223333, jacques.mansourati@chu-brest.fr
Baptiste CHEHERE, PhD, baptiste.chehere@univ-brest.fr
About this study
Official title: Effect of a Personalized Follow-up in Adapted Physical Activities on the Long-term Benefits of Rehabilitation in Subjects With Chronic Heart Failure.
France has one million people with heart failure (HF). Exercise intolerance, characterised by dyspnoea, is the main clinical symptom in HF patients and a key determinant of reduced quality of life. In addition to drug and surgical treatments, cardiac rehabilitation programmes have shown benefits in heart failure patients. Lasting at least 3 weeks, these programmes improve physical abilities, quality of life and reduce the risk of hospitalisation for heart failure patients.
To date, the real challenge is no longer to prove the benefits of cardiac rehabilitation, but to find solutions to maintain its long-term effects. The transition between the end of the supervised programmes in the centre and the return home is a difficult phase for the majority of patients who do not continue regular physical activity and thus quickly lose the benefits of the programme.
Read more
To help maintain the benefits of cardiac rehabilitation, some centres offer patients programmes to continue physical activity during phase III. Although these options are often beneficial in the first few months after the end of rehabilitation compared to control groups, the long-term results are mixed. These results imply that one of these maintenance options may not be suitable for all patients. It is therefore important to propose a personalised post-rehabilitation follow-up involving the patient in the choice of physical activities to optimise the maintenance of long-term benefits.
We hypothesise that patients who receive personalised support from a sport and health professional following rehabilitation maintain long-term benefits compared to a control group who do not receive this support.
- Conditions
- Heart Failure
- Being tested
- Experimental arm
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental armOther
Personalized follow-up in adapted physical activities
| Study group | Role | What they receive |
|---|---|---|
| Commun practice | No intervention | Patient in the control arm will not beneficiate from a follow-up in adapted physical activities (commun practice) |
| Follow-up in adapted physical activities | Experimental | Patient in the control arm will beneficiate from a follow-up in adapted physical activities Receives: Other: Experimental arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the evolution of the level of physical activity 12 months after a cardiac rehabilitation programme between patients benefiting from personalised support at the end of the rehabilitation and a control group benefiting from the usual management.
The primary endpoint will be the difference in mean daily steps measured by accelerometry (over 7 days) at the start of the rehabilitation course (Visit 1) and after 12 months of personalised follow-up (Visit 4).
Measured: 12 months
Secondary outcomes (20)
To compare between the experimental group and the control group, the evolution 12 months after a cardiac rehabilitation programme of time spent in each level of activity :
Levels of activity :
- Sedentary time (min/day)
- Time spent in activity with light intensity (min/day)
- Time spent in activity with moderate intensity (min/day)
- Time spent in activity with vigorous intensity (min/day)
Measured: 12 months
To compare physical capacities measured using the 6-minute walk test between the experimental group and the control group, the evolution 12 months after a cardiac rehabilitation programme
The 6-minute walk test: total walked distance (in metres) The test will be performed twice, the best performance will be kept as reference value.
Measured: 12 months
To compare physical capacities measured using the endurance test between the experimental group and the control group, the evolution 12 months after a cardiac rehabilitation programme
The endurance test: endurance time (in seconds) During this test, the patient will be asked to walk at a constant speed (mean speed measured at the 6 minute walking test). If the patient can walk at the requested speed for more than 10 minutes, a second test is performed. The imposed speed is increased by 10% for this second test.
Measured: 12 months
To compare physical capacities measured using the chair getting-up test between the experimental group and the control group, the evolution 12 months after a cardiac rehabilitation programme
the total number of time when the patient gets up and sit down on a chair during 1 minute is recorded
Measured: 12 months
To compare physical capacities measured using the hand-grip test between the experimental group and the control group, the evolution 12 months after a cardiac rehabilitation programme
The hand-grip test: maximal force (in kg for both hands). the patient will use a dynamometer Hand-grip. The test will be performed 3 times per visit. The force (in Newton) is recorded, the best performance is kept as the reference value
Measured: 12 months
To compare physical capacities measured using the incremental ergocycle test between the experimental group and the control group, the evolution 12 months after a cardiac rehabilitation programme
The incremental ergocycle test: maximal power (watts) and VO2 (mL.min.kg-1) The test is performed on a ergocycle.
Measured: 12 months
To compare the evolution of dyspnea scores 12 months after a cardiac rehabilitation programme between the experimental group and the control group
Dyspnea-12 questionnaire dyspnea scores DYSPNEA 12 : The DYSPNEA 12 comprised of 12 different breathlessness descriptors with each scored on a four-item scale (none-0, mild-1, moderate2, severe-3). Item scores are summed (D-12 Total) and can be divided into sub-scores reflecting Physical and Affective domains.
Measured: 12 months
To compare the psychological dimensions (motivation) between the experimental group and the control group, the evolution 12 months after a cardiac rehabilitation programme
EMAPS questionnaire EMAPS : The questionnaire includes 18 items. The EMAPS is used to evaluate the motivation to practice physical activities. The answer to questions goes from 1 to 7 with 1 (does not match at all) and 7 (matches very strongly).
Measured: 12 months
To compare the psychological dimensions (anxiety/depression) between the experimental group and the control group, the evolution 12 months after a cardiac rehabilitation programme
HAD questionnaire HAD : The questionnaire includes 7 items for depression and 7 items for anxiety. Each item had been answered by the patient on a four point (0-3) response category so the possible scores ranged from 0 to 21 for anxiety and for depression. A score of 0 to 7 for either subscale could be regarded as being in the normal range, a score of 11 or higher indicating probable presence ('caseness') of the mood disorder and a score of 8 to 10 being just suggestive of the presence of the respective state.
Measured: 12 months
To compare the psychological dimensions (quality of life) between the experimental group and the control group, the evolution 12 months after a cardiac rehabilitation programme
SF-36 : The Short Form 36 (SF36) is used to evaluate the quality of life. The SF36 scale includes 36 items divided into 8 dimensions (physical functioning, role limitations related to physical health, physical pain, general health, vitality [energy / fatigue)
Measured: 12 months
To compare the psychological dimensions (quality of life) between the experimental group and the control group, the evolution 12 months after a cardiac rehabilitation programme
EQ5D5L : The questionnaire includes 5 items mobility, personal care, usual activities, pain/discomfort and anxiety/depression.
Measured: 12 months
To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the physiological adaptations during endurance test
Comparison of physiological adaptations assessed in the endurance test
- Ventilatory parameters (minute ventilation, respiratory rate and tidal volume)
Measured: 12 months
To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the physiological adaptations during endurance test
Comparison of physiological adaptations assessed in the endurance test
- Gas exchange (VO2, VCO2)
Measured: 12 months
To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the physiological adaptations during endurance test
Comparison of physiological adaptations assessed in the endurance test
- Cardio-ventilatory parameters (heart rate in beat/min and electrocardiogram (ECG))
Measured: 12 months
To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the physiological adaptations during endurance test
comparison of physiological adaptations assessed in the incremental test:
- Ventilatory parameters (minute ventilation, respiratory rate and tidal volume)
Measured: 12 months
To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the physiological adaptations during endurance test
comparison of physiological adaptations assessed in the incremental test:
- Gas exchange parameters (VO2, VCO2)
Measured: 12 months
To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the physiological adaptations during endurance test
comparison of physiological adaptations assessed in the incremental test:
- Cardiovascular parameters (heart rate in beat/min, electrocardiogram (ECG), systolic and diastolic pression (mmHg)
Measured: 12 months
To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the endothelial dysfunction : microcirculation
- Analyse of skin circulation (laser doppler) with post-occlusive reactive hyperemia et hyperthermia
Measured: 12 months
To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the endothelial dysfunction : macrocirculation
- Analyse by flow-mediated dilatation (FMD) by echography
Measured: 12 months
To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the endothelial dysfunction : blood markers
- Analyses of several blood markers related to endothelial dysfunction, inflammation and/or heart failure : IL-6 ; IL-10; VEGF-A; Ang-1; Ang-2; IL-1β; TNF-α; MCP-1; IL-8; EGF; E-selectine; I-CAM 1; PECAM-1; VCAM-1; tPA; CRP; VWF; NT-pro-BNP; ET-1
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start13 Feb 2024
- Primary completion13 Sep 2027 (estimated)
- Study completion13 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Model description
- Randomised controlled trial of superiority in parallel arms. Randomised parallel group trial divided into groups according to a ratio (1:1) comparing the follow-up and personalised support after a cardiac rehabilitation programme (experimental group) versus a control group receiving only the usual care, i.e. without follow-up by a sports-health professional (control group), in patients with heart failure.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques Mansourati, MD, PhD, Principal investigator, Brest Universty Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222762
- Sponsor's protocol ID
- 29BRC23.0022 - BOUGE TON COEUR
- Acronym
- BougeTonCoeur
- Status last verified
- Jun 2026
- First submitted
- 26 Oct 2023
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Personalized Follow-up in Adapted Physical Activities on the Long-term Benefits of Rehabilitation in Subjects With Chronic Heart Failure.
- ClinicalTrials.gov ID
- NCT06222762
- Acronym / sponsor ID
- BougeTonCoeur / 29BRC23.0022 - BOUGE TON COEUR
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- 13 Sep 2027 (estimated)
- Study completion
- 13 Sep 2027 (estimated)
- First posted
- 25 Jan 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.
France has one million people with heart failure (HF). Exercise intolerance, characterised by dyspnoea, is the main clinical symptom in HF patients and a key determinant of reduced quality of life. In addition to drug and surgical treatments, cardiac rehabilitation programmes have shown benefits in heart failure patients. Lasting at least 3 weeks, these programmes improve physical abilities, quality of life and reduce the risk of hospitalisation for heart failure patients.
To date, the real challenge is no longer to prove the benefits of cardiac rehabilitation, but to find solutions to maintain its long-term effects. The transition between the end of the supervised programmes in the centre and the return home is a difficult phase for the majority of patients who do not continue regular physical activity and thus quickly lose the benefits of the programme.
To help maintain the benefits of cardiac rehabilitation, some centres offer patients programmes to continue physical activity during phase III. Although these options are often beneficial in the first few months after the end of rehabilitation compared to control groups, the long-term results are mixed. These results imply that one of these maintenance options may not be suitable for all patients. It is therefore important to propose a personalised post-rehabilitation follow-up involving the patient in the choice of physical activities to optimise the maintenance of long-term benefits.
We hypothesise that patients who receive personalised support from a sport and health professional following rehabilitation maintain long-term benefits compared to a control group who do not receive this support.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised controlled trial of superiority in parallel arms. Randomised parallel group trial divided into groups according to a ratio (1:1) comparing the follow-up and personalised support after a cardiac rehabilitation programme (experimental group) versus a control group receiving only the usual care, i.e. without follow-up by a sports-health professional (control group), in patients with heart failure.
| Arm | Type | Receives |
|---|---|---|
| Commun practice | No intervention | –Patient in the control arm will not beneficiate from a follow-up in adapted physical activities (commun practice) |
| Follow-up in adapted physical activities | Experimental | Other: Experimental armPatient in the control arm will beneficiate from a follow-up in adapted physical activities |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of stable heart failure with NYHA stage I, II or III
- Participation in a cardiac rehabilitation programme
- Patient agreement
- Patient of legal age
- Patient affiliated to the Social Security
Key exclusion criteria (4 listed)
- Patient refusal
- Minor patients
- Subjects under guardianship or curatorship
- Subjects over 80 years of age 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 |
|---|---|---|
| Experimental armPersonalized follow-up in adapted physical activities | Other | Follow-up in adapted physical activities |
Primary outcome
To compare the evolution of the level of physical activity 12 months after a cardiac rehabilitation programme between patients benefiting from personalised support at the end of the rehabilitation and a control group benefiting from the usual management.
Time frame: 12 months
The primary endpoint will be the difference in mean daily steps measured by accelerometry (over 7 days) at the start of the rehabilitation course (Visit 1) and after 12 months of personalised follow-up (Visit 4).
20 secondary outcomes
To compare between the experimental group and the control group, the evolution 12 months after a cardiac rehabilitation programme of time spent in each level of activity :
Time frame: 12 months
To compare physical capacities measured using the 6-minute walk test between the experimental group and the control group, the evolution 12 months after a cardiac rehabilitation programme
Time frame: 12 months
To compare physical capacities measured using the endurance test between the experimental group and the control group, the evolution 12 months after a cardiac rehabilitation programme
Time frame: 12 months
To compare physical capacities measured using the chair getting-up test between the experimental group and the control group, the evolution 12 months after a cardiac rehabilitation programme
Time frame: 12 months
To compare physical capacities measured using the hand-grip test between the experimental group and the control group, the evolution 12 months after a cardiac rehabilitation programme
Time frame: 12 months
To compare physical capacities measured using the incremental ergocycle test between the experimental group and the control group, the evolution 12 months after a cardiac rehabilitation programme
Time frame: 12 months
To compare the evolution of dyspnea scores 12 months after a cardiac rehabilitation programme between the experimental group and the control group
Time frame: 12 months
To compare the psychological dimensions (motivation) between the experimental group and the control group, the evolution 12 months after a cardiac rehabilitation programme
Time frame: 12 months
To compare the psychological dimensions (anxiety/depression) between the experimental group and the control group, the evolution 12 months after a cardiac rehabilitation programme
Time frame: 12 months
To compare the psychological dimensions (quality of life) between the experimental group and the control group, the evolution 12 months after a cardiac rehabilitation programme
Time frame: 12 months
To compare the psychological dimensions (quality of life) between the experimental group and the control group, the evolution 12 months after a cardiac rehabilitation programme
Time frame: 12 months
To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the physiological adaptations during endurance test
Time frame: 12 months
To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the physiological adaptations during endurance test
Time frame: 12 months
To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the physiological adaptations during endurance test
Time frame: 12 months
To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the physiological adaptations during endurance test
Time frame: 12 months
To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the physiological adaptations during endurance test
Time frame: 12 months
To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the physiological adaptations during endurance test
Time frame: 12 months
To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the endothelial dysfunction : microcirculation
Time frame: 12 months
To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the endothelial dysfunction : macrocirculation
Time frame: 12 months
To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the endothelial dysfunction : blood markers
Time frame: 12 months
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 26 Jun 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
Baptiste Chéhère, PhD contact
Jacques Mansourati, MD, PhD principal investigator
Brest Universty Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental arm in people with Heart Failure, run by University Hospital, Brest at 2 sites 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 Jacques Mansourati, MD, PhD (+33298347405, jacques.mansourati@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the evolution of the level of physical activity 12 months after a cardiac rehabilitation programme between patients benefiting from personalised support at the end of the rehabilitation and a control group benefiting from the usual management. (time frame: 12 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 26 Jun 2026.