Effect of Personalized Follow-up in Adapted Physical Activities in Subjects With Chronic Heart Failure.
- Conditions
- Heart Failure
- Interventions
- Other: Experimental arm
- Registration Number
- NCT06222762
- Lead Sponsor
- University Hospital, Brest
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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
- Patient refusal
- Minor patients
- Subjects under guardianship or curatorship
- Subjects over 80 years of age at the time of inclusion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Follow-up in adapted physical activities Experimental arm Patient in the control arm will beneficiate from a follow-up in adapted physical activities
- Primary Outcome Measures
Name Time Method 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. 12 months 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).
- Secondary Outcome Measures
Name Time Method 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 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.
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 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.
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 the total number of time when the patient gets up and sit down on a chair during 1 minute is recorded
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 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
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 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)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 12 months The incremental ergocycle test: maximal power (watts) and VO2 (mL.min.kg-1) The test is performed on a ergocycle.
To compare the psychological dimensions (anxiety/depression) between the experimental group and the control group, the evolution 12 months after a cardiac rehabilitation programme 12 months 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.
To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the endothelial dysfunction : macrocirculation 12 months - Analyse by flow-mediated dilatation (FMD) by echography
To compare the evolution of dyspnea scores 12 months after a cardiac rehabilitation programme between the experimental group and the control group 12 months 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.
To compare the psychological dimensions (motivation) between the experimental group and the control group, the evolution 12 months after a cardiac rehabilitation programme 12 months 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).
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 12 months EQ5D5L : The questionnaire includes 5 items mobility, personal care, usual activities, pain/discomfort and anxiety/depression.
To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the endothelial dysfunction : blood markers 12 months - 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
To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the physiological adaptations during endurance test 12 months comparison of physiological adaptations assessed in the incremental test:
- Cardiovascular parameters (heart rate in beat/min, electrocardiogram (ECG), systolic and diastolic pression (mmHg)To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the endothelial dysfunction : microcirculation 12 months - Analyse of skin circulation (laser doppler) with post-occlusive reactive hyperemia et hyperthermia
Trial Locations
- Locations (2)
CHU de Brest
🇫🇷Brest, France
Fondation ILDYS
🇫🇷Brest, France