Patient-Reported Outcome Measures and Quality of Life in Cardiac Rehabilitation: Impact on Health Care
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- HADS: Anxiety and depression
研究概览
简要总结
Cardiac Rehabilitation (CR) programs are a multidisciplinary process aimed at patient recovery after an acute cardiovascular event or with chronic heart disease, reducing mortality and morbidity, optimising functional capacity and improving quality of life. The aim is to maintain or recover the patient's clinical, physical and psychosocial condition, slowing down or halting the progression of the underlying disease process. It is based on the practice of personalized physical exercise and the adaptation of behaviours towards a healthier lifestyle, ensuring the reduction and control of risk factors. It is considered a cost-effective intervention that is explicitly and formally recommended by the most diverse and important scientific societies. Through the partnership and collaboration between the various health institutions and the academy, the CR program will take place on an outpatient basis, in a supervised manner, starting after risk stratification with a stress test and respective clinical assessment by a cardiologist. The coordinator of the CR program will be a cardiologist, and the entire multidisciplinary team will be responsible for effectiveness and safety, as well as patient assessment and progress.
详细描述
The outpatient CR program is designed for a group of participants who have had a cardiac event, based on the American College of Sports Medicine's Guidelines for Exercise Testing and Prescription, consisting of two exercise sessions/week. The sessions are supervised by a healthcare professional specialising in cardiac rehabilitation, and the participant's haemodynamic status is monitored continuously using scales and electronic equipment. PROMs will be applied before and after the program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Adult (> 18 years);
- •Low-moderate risk for physical exercise;
- •After a cardiac event;
- •Have signed an informed consent form.
排除标准
- •Physical or mental limitation to carry out an exercise programme;
- •Uncontrolled arrhythmia;
- •Severe chronic obstructive pulmonary disease;
- •Uncontrolled hypertension;
- •Symptomatic peripheral arterial disease;
- •Unstable angina;
- •Uncontrolled diabetes;
- •Acute pulmonary oedema in the last 12 hours;
- •Those who refuse to participate.
结局指标
主要结局
HADS: Anxiety and depression
时间窗: Before the intervention and up to 8 weeks.
Participants' anxiety and worries are also assessed. Mood disorders, weakness, worry, stress, and depression are common psychological repercussions for patients after a cardiac event, which can trigger hyperventilation reactions. This type of common reaction to emotional extremes such as fear, anxiety, or stress in participants can have a direct impact on involvement in CR programs. This questionnaire is made up of 14 questions. Lower scores mean a better result.
EQ5D-5L: Health-related quality of life
时间窗: Before the intervention and up to 8 weeks.
The EQ5D makes it possible to assess quality of life in a given pathology in the general population, presented in different domains. The visual analogue scale of this questionnaire has a score of 0-100. Higher scores mean a better result.
BREQ-2: Behavioural Regulations in Exercise Questionnaire
时间窗: Before the intervention and up to 8 weeks.
Assessment of the different aspects of motivational regulation for exercise. It is a questionnaire that evaluates and represents the differences in the ways in which people's behaviour can be regulated and how these differences are experienced.
次要结局
- Abdominal perimeter(Before the intervention and up to 8 weeks.)
- Peripheral oxygen saturation(Before, during and up to 8 weeks of the program.)
- Exercise Capacity(During and up to 8 weeks of the program.)
- Weight(Before the intervention and up to 8 weeks.)
- Heart rate(Before, during and up to 8 weeks of the program.)
- Blood pressure(Before, during and up to 8 weeks of the program.)
研究者
José Manuel Afonso Moreira
Principal Investigator
University of Évora