NCT06345807尚未招募不适用
Innovative Care Pathway in Physical Activity and Behavior Change in Coronary Patients Post Cardiac Rehabilitation
Elsan0 个研究点目标入组 192 人开始时间: 2024年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 192
- 主要终点
- 6 minutes walk test
研究概览
简要总结
The objective of this 18-month research is to show the effectiveness of an individualized physical activity( PA) compared to standard PA management and voluntary PA, to achieve a change in the behavior of the coronary patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Post-infarction coronary artery patient aged 18 years and older, with no gender difference.
- •Patients engaged in a follow-up care and cardiovascular rehabilitation program at the Supervaltech center.
- •Patient at low to moderate RARE risk of complication (RARE score 2 to 3)
- •Patients equipped with smartphones, laptops or other equipment compatible with downloading an application with their personal ID
- •Patient able to understand French for the purpose of conducting the study.
- •Affiliated member or beneficiary of a social security scheme.
- •Participant who has been informed and has given free, informed and written consent (no later than the day of inclusion and before any examination required by the research).
排除标准
- •Patients with a formal contraindication to physical activity such as: unstabilized coronary syndrome, decompensated heart failure, severe ventricular arrhythmias, intracardiac thrombus at risk embolic, PAH, moderate pericardial effusion, history of thrombophlebitis with or without pulmonary embolism, severe and/or symptomatic left ventricular ejection obstruction.
- •Patients with ongoing infectious disease
- •Participant whose physical and/or psychological health is severely impaired, which in the opinion of the investigator may affect the study participant's compliance.
- •Participant included in other research
- •Participant in a period of exclusion from another research still in progress at the time of inclusion.
- •Protected participant: an adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
- •Pregnant, breastfeeding or parturient women.
- •Participant hospitalized without consent.
结局指标
主要结局
6 minutes walk test
时间窗: 18 months
patient behaviour change measured with the six minute walk test distance
次要结局
未报告次要终点
研究者
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