Clinical trial NCT06222762: Effect of Personalized Follow-up in Adapted Physical Activities in Subjects with Chronic Heart Failure.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: 12 months
Secondary outcomes:
measure: 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 :
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: To compare the evolution of dyspnea scores 12 months after a cardiac rehabilitation programme between the experimental group and the control group
timeFrame: 12 months
measure: To compare the psychological dimensions (motivation) between the experimental group and the control group, the evolution 12 months after a cardiac rehabilitation programme
timeFrame: 12 months
measure: To compare the psychological dimensions (anxiety/depression) between the experimental group and the control group, the evolution 12 months after a cardiac rehabilitation programme
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the physiological adaptations during endurance test
timeFrame: 12 months
measure: To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the physiological adaptations during endurance test
timeFrame: 12 months
measure: To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the physiological adaptations during endurance test
timeFrame: 12 months
measure: To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the physiological adaptations during endurance test
timeFrame: 12 months
measure: To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the physiological adaptations during endurance test
timeFrame: 12 months
measure: To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the physiological adaptations during endurance test
timeFrame: 12 months
measure: To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the physiological adaptations during endurance test
timeFrame: 12 months
measure: To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the physiological adaptations during endurance test
timeFrame: 12 months
measure: To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the endothelial dysfunction : microcirculation
timeFrame: 12 months
measure: To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the endothelial dysfunction : macrocirculation
timeFrame: 12 months
measure: To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the endothelial dysfunction : blood markers
timeFrame: 12 months
Other outcomes:
Locations:
city: Brest
country: France
facility: Fondation ILDYS
city: Brest
country: France
facility: CHU de Brest
Study officials:
affiliation: Brest Universty Hospital
name: Jacques Mansourati, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: