Cardio-Fit2: Impact of a Cardiac Rehabilitation Program in Patients With Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Ergospirometry parameters and functional capacity
研究概览
简要总结
Cardiovascular diseases (CVD) are the main cause of morbidity and mortality in the world, being responsible for 17.9 million deaths annually, according to the World Heart Federation (WHF), which represents a significant social and health cost both due to direct expenses derived from admissions and diagnostic-therapeutic methods, as well as indirect expenses secondary to work incapacity, disability and loss of autonomy that this generates. Although advanced diagnostic and therapeutic techniques have been incorporated in recent years in the acute phase of ischemic heart disease, interventions during hospitalization and after hospital discharge remain insufficient in terms of secondary prevention, a paradoxical fact, since increasingly, the available evidence, as well as the recommendation guidelines, focus on the modification of lifestyle habits and control of cardiovascular risk factors (CVRF), fundamental pillars of cardiac rehabilitation programs (PRC) as a preventive measure both in the appearance of new adverse events and in the reduction of disease progression and improvement of the functional capacity of the patient. Cardiac rehabilitation (CR) was defined by the World Health Organization (WHO) in the 1960s as "the set of activities necessary to ensure that heart patients have an optimal physical, mental and social condition, allowing them to occupy, by their own means, as normal a place as possible in society." The scientific evidence is more than consistent regarding the benefits that multidisciplinary CRP provides in terms of cardiovascular mortality and quality of life (QoL) of our patients and how these results are maintained despite changes in patient characteristics and risk, or the incorporation of new pharmacological treatments. Therefore, if we deprive our patients of these therapies, we are indirectly acting negatively on their cardiovascular prognosis, especially within the field of ischemic heart disease, although it is increasingly being extended to other areas of Cardiology such as heart failure (HF), pulmonary hypertension (PH), valvular disease,7 etc. So much so that it is already included in the latest clinical practice guidelines of the main scientific societies at European and American level, establishing participation in a CR program after acute coronary syndrome or coronary revascularization and those patients with HF as a "level of recommendation I evidence A"
详细描述
Currently, due to both the high percentage of patients with cardiovascular disease and the potential increase in sedentary lifestyle, with the geographical dispersion of some territories such as our integrated care area, it is vital to seek effective alternatives so that therapeutic exercise programs are carried out regularly, given that this sedentary attitude can increase the risk of mortality.40 This gives impetus to remote interventions such as telerehabilitation, as a useful paradigm to reduce this risk by being a set of technologies that has facilitated the application, monitoring and follow-up of physical exercise programming.
In today's technological era, the Internet of Things (IoT) paradigm has facilitated the incorporation of connected devices, such as smart tablets, motion sensors, activity trackers, and virtual reality systems, capable of monitoring physiological and behavioral variables in real time and acting on the data collected, thus enabling remote, personalized, and continuous interventions. These advances have begun to be used in healthcare and rehabilitation settings, with promising results.
In this way, an association has been evidenced between the home use of these technologies with moderate to high levels of participation in RCD and patient satisfaction with this modality; 46,47 with similar benefits in improving cardiovascular and psychological health, 48 which suggests that RCD with technological support is a viable option to monitor and even increase participation in the RC process, 46,48 especially for those patients who, due to their employment situation or geographical dispersion, do not have easy access to PRC. It should be taken into account that RCD may entail less medical supervision, control of physical exercise sessions with telemetry and monitoring, security and social interaction, but it is an alternative to achieve maintenance of physical activity levels in patients with CVD. 42 Some authors even recommend RCD in high-risk patients, given that the cardiovascular and psychological benefits that can be obtained by performing low-impact physical exercise at home are greater than the relative risk of an adverse event.
In this regard, several authors have shown that the implementation of home-based training protocols is safe and feasible for patients with low- and moderate-risk CVD; 50-53 with no significant difference in the relative risk of mortality between both CR modalities. 43 Other reviews reached similar conclusions without differentiating between total mortality, exercise capacity and QoL between the RCD and RCT groups. However, there was evidence of marginally higher levels of program completion by home-based participants.
One of the main weaknesses of the RCD is the lack of direct patient monitoring during the program. In this sense, the use of wearable devices overcomes this limitation, as it facilitates remote monitoring of patient activity, increasing accessibility to the RCP for people who would otherwise be unable to benefit from them. Furthermore, the use of these devices during the program contributes to improving adherence by allowing more precise monitoring of both exercise performance and various physiological variables that they record in real time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Both the researchers who manage the data and include it in the database, as well as those who analyze it, will not know the intervention that the participants have received.
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between the ages of 20 and
- •Have suffered an acute event or have chronic cardiovascular disease with decreased/limited functional capacity.
- •Reside in the provinces of Cuenca, Toledo, or Albacete.
- •Willingness to participate voluntarily and acceptance of the conditions.
- •Must report the ability to access new technologies.
排除标准
- •Have a physical or mental condition that prevents participation.
- •Inability to adhere to the entire program, as reported in the initial consultation.
- •Are outside the age criteria defined above.
研究组 & 干预措施
Hospital Cardiac rehabilitation
The hospital cardiac rehabilitation group will attend the hospital 3 days a week for the same, for eight weeks.
干预措施: Hospital Cardiac Rehabilitation (Other)
Semi-presential or hibrid group
The hybrid format will consist of 4 in-person sessions (every two weeks) complemented by a home program until completing 3 sessions of the full program at home
干预措施: Semi-presential or hybrid group (Other)
结局指标
主要结局
Ergospirometry parameters and functional capacity
时间窗: Baseline and up to eight weeks.
Ergospirometry will be performed, in which the following parameters will be collected: VO2 peak (ml/Kg/min).
次要结局
- SpO2(Baseline and up to eight weeks)
- Anthropometric data(Baseline and up to eight weeks)
- Heart rate(Baseline and up to eight weeks)
- Mediterranean Diet Adherence Questionnaire (PREDIMED)(Baseline and up to eight weeks)
- Spirometric parameters: FEV1(Baseline and up to eight weeks)
- Analysis of Photoplethysmography signals(Baseline and up to eight weeks)
- Blood pressure(Baseline and up to eight weeks)
- BMI(Baseline and up to eight weeks)
- Biochemical parameters: HbA1c(Baseline and up to eight weeks)
- Muscle strength(Baseline and up to eight weeks)
- Anthropometric data: height(Baseline and up to eight weeks)
- Dyspnoea(Baseline and up to eight weeks)
- Nutritional ultrasound 1(Baseline and up to eight weeks)
- Ultrasound measurements of subcutaneous adipose tissue(Baseline and up to eight weeks)
- Anxiety(Baseline and up to eight weeks)
- Respiratory muscle strength(Baseline and up to eight weeks)
- Cardiac Rehabilitation Program Satisfaction Questionnaire(up to eight weeks)
- Biochemical parameters: interleukins(Baseline and up to eight weeks)
- Spirometric parameters: FEV1/FVC(Baseline and up to eight weeks)
- Quality of Life Questionnaire (SF-12)(Baseline and up to eight weeks)
- Pittsburgh Sleep Quality Questionnaire(Baseline and up to eight weeks)
- Depression(Baseline and up to eight weeks)
- Spirometric parameters: FVC(Baseline and up to eight weeks)
- Ultrasound measurements of visceral adipose tissue(Baseline and up to eight weeks)
- Biochemical parameters: cholesterol(Baseline and up to eight weeks)
- Biochemical parameters: triglycerides(Baseline and up to eight weeks)
- Biochemical parameters: pro-BNP(Baseline and up to eight weeks)
- Respiratory muscle strength: PEM(Baseline and up to eight weeks)
研究者
Susana Priego Jiménez
Diploma in physiotherapy, PhD in Socio-Health and Physical Activity Research from the UCLM International Doctoral School, with a distinction of OUTSTANDING CUM LAUDE.
Hospital Virgen de la Luz