Clinical trial NCT06127537: Study on the Efficacy of HE and Therapeutic Group Factors on CR and QoL
Official title: Study on the Efficacy of Health Education and Therapeutic Group Factors on Cardiac Rehabilitation and Quality of Life in Coronary Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Rehabilitation
Keywords: Quality of Life
Cardiovascular Disease
Health Education
Lead sponsor: Universidad de Extremadura
Sponsor class: OTHER
Collaborators: name: European Regional Development Fund
First posted: 2023-11-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of coronary heart disease, referred to the "Cardiac Prevention and Rehabilitation Unit".

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Changes in basal cardiac function and stress reactivity at 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in blood pressure over 8 weeks
timeFrame: 0 and 8 weeks
measure: Change in cardiovascular health indicators over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in physical activity at 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in maximum prehensile strength over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in quality of life indicators over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in Physical Function quality score over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in Physical Role quality score over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in Bodily Pain quality score over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in General Health quality score over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in Vitality quality score over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in Social Function quality score over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in Emotional Role and Mental Health quality score over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in Health perception over 8 weeks
timeFrame: 0 and 8 weeks
Secondary outcomes:
measure: Changes in body weight composition over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in body fat mass composition over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in body fat-free mass composition over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in estimated total body water composition over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in protein composition over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in bone mineral composition over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in Body Mass Index over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in CUN-BAE index over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in phase angle bioimpedance over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in the percentage of carbohydrates ingested over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in the percentage of fat ingested over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in the percentage of protein ingested over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in the percentage of vitamins ingested over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in kilocalorie intake over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in adherence to the Mediterranean diet over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in erythrocyte parameters over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in glucose level over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in plasma albumin parameters over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in total lymphocyte over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in total triglycerides levels over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in total cholesterol level over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in high-density lipoproteins levels over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in low-density lipoproteins levels over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in psychological parameters over 8 weeks
timeFrame: 0 and 8 weeks
measure: Changes in adherence over 8 weeks
timeFrame: 0 and 8 weeks
Other outcomes:
Locations:
city: Badajoz
country: Spain
facility: Servicio Extremeño de Salud
Study officials:
affiliation: University of Extremadura
name: Francisco J Rodríguez Velasco, PhD
role: PRINCIPAL_INVESTIGATOR
References: