Study on the Efficacy of Health Education and Therapeutic Group Factors on Cardiac Rehabilitation and Quality of Life in Coronary Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Changes in basal cardiac function and stress reactivity at 8 weeks
研究概览
简要总结
This randomised study evaluates the efficacy of health education and therapeutic group factors on cardiac rehabilitation and quality of life in coronary patients attending cardiac rehabilitation programmes in Extremadura.
详细描述
Cardiac rehabilitation has been shown to be effective in improving the quality of life of patients who have suffered a cardiovascular event, as well as in preventing future cardiovascular events, demonstrating an increase in survival of between 20% and 30%, with a Class IA recommendation. Due to the prevalence of cardiovascular disease, both nationally and globally, it is important to study the benefits of these cardiac rehabilitation programmes in order to encourage their use. However, several studies have shown that for the programme to be effective, 5% to 10% weight loss must be achieved in patients, adequate nutritional education must be implemented, and behavioural and psychological intervention programmes must be incorporated in order to have an impact on adherence, psychological well-being, and coping with exercise intolerance. This project aims to study the effectiveness of health education and therapeutic group factors in cardiac rehabilitation and on quality of life in coronary patients in Cardiac Rehabilitation Units in Extremadura, including in the analysis anthropometric and body composition, nutritional, cognitive, emotional and lifestyle factors, which could act as mediators of cardiac function, reactivity to neuro-cardiovascular stress, anxiety, depression, anger-hostility, rehospitalisation, adherence, and adherence to treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Diagnosis of coronary heart disease, referred to the "Cardiac Prevention and Rehabilitation Unit".
排除标准
- •Patients with disabling psychiatric disorders.
- •Existence of pacemaker or automatic defibrillator.
- •Presence of pregnancy or breastfeeding.
- •Presence of medical conditions related to oncological conditions requiring chronic treatment with drugs or other substances.
- •Any condition that, in the opinion of the investigators, would disqualify the subject from participation in the study.
结局指标
主要结局
Changes in basal cardiac function and stress reactivity at 8 weeks
时间窗: 0 and 8 weeks
Changes in heart rate (bpm) are monitored at rest, during treadmill or stationary bicycle exercise and in recovery (by ergometry - PEG).
Change in cardiovascular health indicators over 8 weeks
时间窗: 0 and 8 weeks
Change in the Fuster-BEWAT score (FBS): this index is derived from cardiovascular health indicators blood pressure (mmHg), physical activity (METs), body mass index (kg/m2), fruit and vegetable consumption, and smoking status; 0-1 indicates poor cardiovascular health; 2-3, intermediate; and 4-5, ideal.
Changes in Vitality quality score over 8 weeks
时间窗: 0 and 8 weeks
Items from the SF36 (Short Form 36) survey. The analysis of the responses is based on the calculation for domain with a scale between 0 (worst health status) and 100 (best health status), after coding, aggregation and transformation of the items that make up each domain.
Changes in Social Function quality score over 8 weeks
时间窗: 0 and 8 weeks
Items from the SF36 (Short Form 36) survey. The analysis of the responses is based on the calculation for domain with a scale between 0 (worst health status) and 100 (best health status), after coding, aggregation and transformation of the items that make up each domain.
Changes in General Health quality score over 8 weeks
时间窗: 0 and 8 weeks
Items from the SF36 (Short Form 36) survey. The analysis of the responses is based on the calculation for domain with a scale between 0 (worst health status) and 100 (best health status), after coding, aggregation and transformation of the items that make up each domain.
Changes in maximum prehensile strength over 8 weeks
时间窗: 0 and 8 weeks
Changes in maximal upper limb prehensile strength by dynamometry (kg).
Changes in Emotional Role and Mental Health quality score over 8 weeks
时间窗: 0 and 8 weeks
Items from the SF36 (Short Form 36) survey. The analysis of the responses is based on the calculation for domain with a scale between 0 (worst health status) and 100 (best health status), after coding, aggregation and transformation of the items that make up each domain.
Changes in blood pressure over 8 weeks
时间窗: 0 and 8 weeks
Changes in blood pressure (mmHg) are monitored at rest, during exercise on a treadmill or stationary bike and in recovery. (by ergometry - PEG).
Changes in quality of life indicators over 8 weeks
时间窗: 0 and 8 weeks
Changes in the Spanish Quality of Life Questionnaire scores in post-infarction patients will be studied. The score per item ranges from 1 (never) to 5 (always). The minimum score is 40 (best health status) and the maximum 200 points (worst health status).
Changes in Physical Function quality score over 8 weeks
时间窗: 0 and 8 weeks
Items from the SF36 (Short Form 36) survey. The analysis of the responses is based on the calculation for domain with a scale between 0 (worst health status) and 100 (best health status), after coding, aggregation and transformation of the items that make up each domain.
Changes in Physical Role quality score over 8 weeks
时间窗: 0 and 8 weeks
Items from the SF36 (Short Form 36) survey. The analysis of the responses is based on the calculation for domain with a scale between 0 (worst health status) and 100 (best health status), after coding, aggregation and transformation of the items that make up each domain.
Changes in Bodily Pain quality score over 8 weeks
时间窗: 0 and 8 weeks
Items from the SF36 (Short Form 36) survey. The analysis of the responses is based on the calculation for domain with a scale between 0 (worst health status) and 100 (best health status), after coding, aggregation and transformation of the items that make up each domain.
Changes in physical activity at 8 weeks
时间窗: 0 and 8 weeks
Changes in physical activity using the International Physical Activity Questionnaire (IPAQ): Weekly activity is recorded in Mets (Metabolic Task Equivalent or Metabolic Rate Units) per minute per week (Cat 1 - Low: \<25 Mets / Cat 2 - Moderate: 25-600 Mets / Cat 3 - High: \>1500 Mets).
Changes in Health perception over 8 weeks
时间窗: 0 and 8 weeks
Changes in health perception will be calculated from the score of the Spanish Quality of Life Questionnaire in post-infarction patients. The score per item ranges from 1 (never) to 5 (always). The minimum score is 40 (best health status) and the maximum 200 points (worst health status).
次要结局
- Changes in body fat mass composition over 8 weeks(0 and 8 weeks)
- Changes in bone mineral composition over 8 weeks(0 and 8 weeks)
- Changes in the percentage of carbohydrates ingested over 8 weeks(0 and 8 weeks)
- Changes in the percentage of fat ingested over 8 weeks(0 and 8 weeks)
- Changes in protein composition over 8 weeks(0 and 8 weeks)
- Changes in Body Mass Index over 8 weeks(0 and 8 weeks)
- Changes in CUN-BAE index over 8 weeks(0 and 8 weeks)
- Changes in phase angle bioimpedance over 8 weeks(0 and 8 weeks)
- Changes in low-density lipoproteins levels over 8 weeks(0 and 8 weeks)
- Changes in kilocalorie intake over 8 weeks(0 and 8 weeks)
- Changes in body weight composition over 8 weeks(0 and 8 weeks)
- Changes in body fat-free mass composition over 8 weeks(0 and 8 weeks)
- Changes in erythrocyte parameters over 8 weeks(0 and 8 weeks)
- Changes in plasma albumin parameters over 8 weeks(0 and 8 weeks)
- Changes in total cholesterol level over 8 weeks(0 and 8 weeks)
- Changes in psychological parameters over 8 weeks(0 and 8 weeks)
- Changes in the percentage of protein ingested over 8 weeks(0 and 8 weeks)
- Changes in estimated total body water composition over 8 weeks(0 and 8 weeks)
- Changes in the percentage of vitamins ingested over 8 weeks(0 and 8 weeks)
- Changes in adherence over 8 weeks(0 and 8 weeks)
- Changes in adherence to the Mediterranean diet over 8 weeks(0 and 8 weeks)
- Changes in glucose level over 8 weeks(0 and 8 weeks)
- Changes in total lymphocyte over 8 weeks(0 and 8 weeks)
- Changes in total triglycerides levels over 8 weeks(0 and 8 weeks)
- Changes in high-density lipoproteins levels over 8 weeks(0 and 8 weeks)
研究者
Francisco Jose Rodriguez Velasco
Professor PhD, University of Extremadura
Universidad de Extremadura