An interventional study of Therapeutic Intervention Group in Cardiac Rehabilitation, sponsored by Universidad de Extremadura. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-13.
Sponsored by Universidad de Extremadura · Not applicable, Interventional, and Treatment
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.
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.
5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.
This study's planned enrollment of 200 is above the median of 100 across 2,801 interventional studies indexed under Cardiovascular Diseases.
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Exclusion Criteria:
Health Education Programme in cardiac rehabilitation without a Therapeutic Intervention Group
Health Education Programme in cardiac rehabilitation with a Therapeutic Intervention Group
Behavioral: Therapeutic Intervention Group
The therapeutic group factors that are worked on in the group session with a psychologist are: * Altruism. * Cohesion: feeling of belonging and acceptance in a group. * Universality: identification with the feelings, ideas or problems of the other group members. * Interpersonal-internalisation learning: the patient understands himself/herself by sharing his/her experience with the group. * Interpersonal-externalisation learning: the group offers the patient the possibility to express his own experience and to change his attitudes towards others. * Counselling. * Identification: assumption of behavioural patterns of other members as one's own. * Reactualisation of the family experience. * Understanding of one's own internal motivations. * Reciprocal stimulation: the improvement of other members encourages them to solve or approach their problems in a more favourable way. * Existential factors: empowerment of the individual.
Changes in basal cardiac function and stress reactivity at 8 weeks
Changes in heart rate (bpm) are monitored at rest, during treadmill or stationary bicycle exercise and in recovery (by ergometry - PEG).
Time frame: 0 and 8 weeks
Changes in blood pressure over 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).
Time frame: 0 and 8 weeks
Change in cardiovascular health indicators over 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.
Time frame: 0 and 8 weeks
Changes in physical activity at 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).
Time frame: 0 and 8 weeks
Changes in maximum prehensile strength over 8 weeks
Changes in maximal upper limb prehensile strength by dynamometry (kg).
Time frame: 0 and 8 weeks
Changes in quality of life indicators over 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).
Time frame: 0 and 8 weeks
Changes in Physical Function quality score over 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.
Time frame: 0 and 8 weeks
Changes in Physical Role quality score over 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.
Time frame: 0 and 8 weeks
Changes in Bodily Pain quality score over 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.
Time frame: 0 and 8 weeks
Changes in General Health quality score over 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.
Time frame: 0 and 8 weeks
Changes in Vitality quality score over 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.
Time frame: 0 and 8 weeks
Changes in Social Function quality score over 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.
Time frame: 0 and 8 weeks
Changes in Emotional Role and Mental Health quality score over 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.
Time frame: 0 and 8 weeks
Changes in Health perception over 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).
Time frame: 0 and 8 weeks
Changes in body weight composition over 8 weeks
Total patient weight are measured as a kilogram (kg).
Time frame: 0 and 8 weeks
Changes in body fat mass composition over 8 weeks
Total patient body fat mass are measured as a kilogram (kg).
Time frame: 0 and 8 weeks
Changes in body fat-free mass composition over 8 weeks
Total patient body fat-free mass are measured as a kilogram (kg).
Time frame: 0 and 8 weeks
Changes in estimated total body water composition over 8 weeks
Total patient estimated total body water are measured as a kilogram (kg).
Time frame: 0 and 8 weeks
Changes in protein composition over 8 weeks
Total patient protein are measured as a kilogram (kg).
Time frame: 0 and 8 weeks
Changes in bone mineral composition over 8 weeks
Total patient bone mineral are measured as a kilogram (kg).
Time frame: 0 and 8 weeks
Changes in Body Mass Index over 8 weeks
Weight (kg) and Height (m) will be combined to report BMI in kg/m\^2.
Time frame: 0 and 8 weeks
Changes in CUN-BAE index over 8 weeks
CUN-BAE are calculated as -44.988+(0.503×age) +(10.689 ×sex) +(3.172×BMI) -(0.026×BMI2) +(0.181×BMI×sex) -(0.02×BMI×age) -(0.005×BMI2 ×sex) +(0.00021×BMI2×age), where male=0 and female=1 for sex, measuring age in years.
Time frame: 0 and 8 weeks
Changes in phase angle bioimpedance over 8 weeks
Phase angle is measured in degrees (º).
Time frame: 0 and 8 weeks
Changes in the percentage of carbohydrates ingested over 8 weeks
A standardised food consumption questionnaire will be used to assess dietary habits, which collects food intake over 7 days. The weekly nutrient intake will be transformed into "Food Composition Tables". The value obtained will be the percentage of carbohydrates (%).
Time frame: 0 and 8 weeks
Changes in the percentage of fat ingested over 8 weeks
A standardised food consumption questionnaire will be used to assess dietary habits, which collects food intake over 7 days. The weekly nutrient intake will be transformed into "Food Composition Tables". The value obtained will be the percentage of fat ingested (%).
Time frame: 0 and 8 weeks
Changes in the percentage of protein ingested over 8 weeks
A standardised food consumption questionnaire will be used to assess dietary habits, which collects food intake over 7 days. The weekly nutrient intake will be transformed into "Food Composition Tables". The value obtained will be the percentage of protein ingested (%).
Time frame: 0 and 8 weeks
Changes in the percentage of vitamins ingested over 8 weeks
A standardised food consumption questionnaire will be used to assess dietary habits, which collects food intake over 7 days. The weekly nutrient intake will be transformed into "Food Composition Tables". The value obtained will be the percentage of vitamins ingested (%).
Time frame: 0 and 8 weeks
Changes in kilocalorie intake over 8 weeks
A standardised food consumption questionnaire will be used to assess dietary habits, which collects food intake over 7 days. The weekly nutrient intake shall be transformed into "Food composition tables". The value obtained will be the number of kilocalories ingested (kcal).
Time frame: 0 and 8 weeks
Changes in adherence to the Mediterranean diet over 8 weeks
Changes in adherence to the Mediterranean diet. This will be studied using the Mediterranean Diet Adherence Questionnaire, which consists of 15 items with values ranging from \<9 (low adherence) to \>=9 (good adherence).
Time frame: 0 and 8 weeks
Changes in erythrocyte parameters over 8 weeks
Erythrocyte parameters are measured as a percentage \[%\]
Time frame: 0 and 8 weeks
Changes in glucose level over 8 weeks
Glucose is measured as a milligrams per decilitre \[mg/dl\]
Time frame: 0 and 8 weeks
Changes in plasma albumin parameters over 8 weeks
Plasma albumin are measured as a \[g/dl\]
Time frame: 0 and 8 weeks
Changes in total lymphocyte over 8 weeks
Total lymphocyte count are measured as a percentage \[%\]
Time frame: 0 and 8 weeks
Changes in total triglycerides levels over 8 weeks
Total lymphocyte count are measured as a milligrams per decilitre \[mg/dl\]
Time frame: 0 and 8 weeks
Changes in total cholesterol level over 8 weeks
Total cholesterol are measured as a milligrams per decilitre \[mg/dl\]
Time frame: 0 and 8 weeks
Changes in high-density lipoproteins levels over 8 weeks
High-density lipoproteins are measured as a milligrams per decilitre \[mg/dl\]
Time frame: 0 and 8 weeks
Changes in low-density lipoproteins levels over 8 weeks
Low-density lipoproteins are measured as a milligrams per decilitre \[mg/dl\]
Time frame: 0 and 8 weeks
Changes in psychological parameters over 8 weeks
Changes in STATE-TRAIT ANXIETY scores measured by the State-Trait Anxiety Questionnaire (STAI). It consists of 40 items divided into 2 subscales: trait and state, with Likert-type responses from 0 to 3. The score can range from 0 to 60. There are no cut-off points, but the direct scores are transformed into centiles according to sex and age.
Time frame: 0 and 8 weeks
Changes in adherence over 8 weeks
Change in Morisky Green Test scores. It consists of 4 items. The patient is considered to be compliant if he/she answers correctly to all 4 items. Parameter will be measured as compliant / not compliant-
Time frame: 0 and 8 weeks
Plan to share: No
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Universidad de Extremadura