Effect of a Personalized Follow-up in Adapted Physical Activities on the Long-term Benefits of Rehabilitation in Subjects With Chronic Heart Failure.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patient refusal
- •Minor patients
- •Subjects under guardianship or curatorship
- •Subjects over 80 years of age at the time of inclusion
研究组 & 干预措施
Follow-up in adapted physical activities
Patient in the control arm will beneficiate from a follow-up in adapted physical activities
干预措施: Experimental arm (Other)
Commun practice
Patient in the control arm will not beneficiate from a follow-up in adapted physical activities (commun practice)
结局指标
主要结局
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.
时间窗: 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).
次要结局
- 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)
- 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)
- To compare the evolution of dyspnea scores 12 months after a cardiac rehabilitation programme between the experimental group and the control group(12 months)
- 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)
- 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 the psychological dimensions (anxiety/depression) between the experimental group and the control group, the evolution 12 months after a cardiac rehabilitation programme(12 months)
- 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)
- To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the physiological adaptations during endurance test(12 months)
- 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)
- 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)
- To compare the evolution of dyspnea scores 12 months after a cardiac rehabilitation programme between the experimental group and the control group(12 months)
- 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)
- 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)
- 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)
- To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the physiological adaptations during endurance test(12 months)
- To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the endothelial dysfunction : microcirculation(12 months)
- To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the endothelial dysfunction : macrocirculation(12 months)
- To compare, between groups, the evolution 12 months after a cardiac rehabilitation programme of the endothelial dysfunction : blood markers(12 months)