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

NCT06222762 | Recruiting DMC

• 1 other identifier: 29BRC23.0022 - BOUGE TON COEUR
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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 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 :

  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

  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

  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

  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

  12 months

Study Arms (2)

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

Other: Experimental arm

Interventions

Experimental arm OTHER

Personalized follow-up in adapted physical activities

Follow-up in adapted physical activities

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient refusal
• Minor patients
• Subjects under guardianship or curatorship

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (2)

Fondation ILDYS

Brest, 29200, France

RECRUITING

CHU de Brest

Brest, 29609, France

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jacques Mansourati, MD, PhD

  Brest Universty Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacques Mansourati, MD, PhD

CONTACT

+33298347405; jacques.mansourati@chu-brest.fr

Baptiste Chéhère, PhD

CONTACT

baptiste.chehere@univ-brest.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: January 25, 2024
• Study Start: February 13, 2024
• Primary Completion (Estimated): September 13, 2027
• Study Completion (Estimated): September 13, 2027
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning five years and ending fifteen years following the final study report completion
• 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

Locations

FR (2)