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

ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity Hospital, Brest

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of stable heart failure with NYHA stage I, II or III

Participation in a cardiac rehabilitation programme

Patient agreement

Patient of legal age

Disqualifiers

Patient refusal

Minor patients

Subjects under guardianship or curatorship

Subjects over 80 years of age at the time of inclusion

Trial design

Design model

Parallel

Treatments tested in this trial

  • Experimental arm

    Other intervention

    Personalized follow-up in adapted physical activities

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Commun practiceNo intervention 0 interventions
Group B: Follow-up in adapted physical activitiesExperimental treatment 1 intervention

Trial outcomes

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).

Time frame
12 months

Secondary outcomes

1

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)

Time frame
12 months
2

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.

Time frame
12 months
3

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.

Time frame
12 months
4

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

Time frame
12 months

Other outcomes

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