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

NCT ID: NCT06222762

Last Updated: 2025-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-13

Study Completion Date

2027-09-13

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Commun practice

Patient in the control arm will not beneficiate from a follow-up in adapted physical activities (commun practice)

Group Type NO_INTERVENTION

No interventions assigned to this group

Follow-up in adapted physical activities

Patient in the control arm will beneficiate from a follow-up in adapted physical activities

Group Type EXPERIMENTAL

Experimental arm

Intervention Type OTHER

Personalized follow-up in adapted physical activities

Interventions

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Experimental arm

Personalized follow-up in adapted physical activities

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacques Mansourati, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Brest Universty Hospital

Locations

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Fondation ILDYS

Brest, , France

Site Status RECRUITING

CHU de Brest

Brest, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jacques Mansourati, MD, PhD

Role: CONTACT

+33298347405

Baptiste Chéhère, PhD

Role: CONTACT

Facility Contacts

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Klervie BAILLY, Md

Role: primary

33298028317

Jacques MANSOURATI, Md, PhD

Role: primary

33298223333

Baptiste CHEHERE, PhD

Role: backup

Other Identifiers

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29BRC23.0022 - BOUGE TON COEUR

Identifier Type: -

Identifier Source: org_study_id

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