Effect of Personalized Follow-up in Adapted Physical Activities in Subjects With Chronic Heart Failure. (BougeTonCoeur)

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.

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 Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: Experimental arm

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jacques Mansourati, MD, PhD; Phone Number: +33298347405; Email: jacques.mansourati@chu-brest.fr
• Study Contact Backup: Name: Baptiste CHEHERE, PhD; Email: baptiste.chehere@univ-brest.fr

Study Locations

• France
  • Brest, France, 29609
    • Recruiting
    • CHU de Brest
    • Contact: Baptiste CHEHERE, PhD; Email: baptiste.chehere@univ-brest.fr
    • Contact: Jacques MANSOURATI, Md, PhD; Phone Number: 33298223333; Email: jacques.mansourati@chu-brest.fr
  • Brest, France, 29200
    • Recruiting
    • Fondation Ildys
    • Contact: Klervie BAILLY, Md; Phone Number: 33298028317; Email: klervie.bailly@ildys.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patient refusal
• Minor patients
• Subjects under guardianship or curatorship
• Subjects over 80 years of age at the time of inclusion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Commun practice; Patient in the control arm will not beneficiate from a follow-up in adapted physical activities (commun practice)
Experimental: Follow-up in adapted physical activities; Patient in the control arm will beneficiate from a follow-up in adapted physical activities	Other: Experimental arm; Personalized follow-up in adapted physical activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	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.	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	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	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.	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.	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).	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.	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)	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.	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	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	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	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)	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))	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)	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)	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)	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)	12 months

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Principal Investigator: Jacques Mansourati, MD, PhD, Brest Universty Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2024
• Primary Completion (Estimated): September 13, 2027
• Study Completion (Estimated): September 13, 2027

Study Registration Dates

• First Submitted: October 26, 2023
• First Submitted That Met QC Criteria: January 15, 2024
• First Posted (Actual): January 25, 2024

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 5, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 29BRC23.0022 - BOUGE TON COEUR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning five years and ending fifteen years following the final study report completion
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No