Study on the Efficacy of HE and Therapeutic Group Factors on CR and QoL

Cardiac Rehabilitation Clinical Trial

Official title:

Study on the Efficacy of Health Education and Therapeutic Group Factors on Cardiac Rehabilitation and Quality of Life in Coronary Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06127537
• Other study ID #: 134/2020
• Secondary ID: IB20186134/20201
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: June 16, 2024

Study information

• Verified date: November 2023
• Source: Universidad de Extremadura
• Contact: Francisco J Rodríguez Velasco, PhD
• Phone: +34 924289839
• Email: fcorodriguezv[@]unex.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 16, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Rehabilitation

Intervention

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.

Locations

Country	Name	City	State
Spain	Servicio Extremeño de Salud	Badajoz

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Extremadura	European Regional Development Fund

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	0 and 8 weeks
Primary	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).	0 and 8 weeks
Primary	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.	0 and 8 weeks
Primary	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).	0 and 8 weeks
Primary	Changes in maximum prehensile strength over 8 weeks	Changes in maximal upper limb prehensile strength by dynamometry (kg).	0 and 8 weeks
Primary	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).	0 and 8 weeks
Primary	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.	0 and 8 weeks
Primary	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.	0 and 8 weeks
Primary	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.	0 and 8 weeks
Primary	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.	0 and 8 weeks
Primary	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.	0 and 8 weeks
Primary	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.	0 and 8 weeks
Primary	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.	0 and 8 weeks
Primary	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).	0 and 8 weeks
Secondary	Changes in body weight composition over 8 weeks	Total patient weight are measured as a kilogram (kg).	0 and 8 weeks
Secondary	Changes in body fat mass composition over 8 weeks	Total patient body fat mass are measured as a kilogram (kg).	0 and 8 weeks
Secondary	Changes in body fat-free mass composition over 8 weeks	Total patient body fat-free mass are measured as a kilogram (kg).	0 and 8 weeks
Secondary	Changes in estimated total body water composition over 8 weeks	Total patient estimated total body water are measured as a kilogram (kg).	0 and 8 weeks
Secondary	Changes in protein composition over 8 weeks	Total patient protein are measured as a kilogram (kg).	0 and 8 weeks
Secondary	Changes in bone mineral composition over 8 weeks	Total patient bone mineral are measured as a kilogram (kg).	0 and 8 weeks
Secondary	Changes in Body Mass Index over 8 weeks	Weight (kg) and Height (m) will be combined to report BMI in kg/m^2.	0 and 8 weeks
Secondary	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.	0 and 8 weeks
Secondary	Changes in phase angle bioimpedance over 8 weeks	Phase angle is measured in degrees (º).	0 and 8 weeks
Secondary	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 (%).	0 and 8 weeks
Secondary	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 (%).	0 and 8 weeks
Secondary	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 (%).	0 and 8 weeks
Secondary	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 (%).	0 and 8 weeks
Secondary	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).	0 and 8 weeks
Secondary	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).	0 and 8 weeks
Secondary	Changes in erythrocyte parameters over 8 weeks	Erythrocyte parameters are measured as a percentage [%]	0 and 8 weeks
Secondary	Changes in glucose level over 8 weeks	Glucose is measured as a milligrams per decilitre [mg/dl]	0 and 8 weeks
Secondary	Changes in plasma albumin parameters over 8 weeks	Plasma albumin are measured as a [g/dl]	0 and 8 weeks
Secondary	Changes in total lymphocyte over 8 weeks	Total lymphocyte count are measured as a percentage [%]	0 and 8 weeks
Secondary	Changes in total triglycerides levels over 8 weeks	Total lymphocyte count are measured as a milligrams per decilitre [mg/dl]	0 and 8 weeks
Secondary	Changes in total cholesterol level over 8 weeks	Total cholesterol are measured as a milligrams per decilitre [mg/dl]	0 and 8 weeks
Secondary	Changes in high-density lipoproteins levels over 8 weeks	High-density lipoproteins are measured as a milligrams per decilitre [mg/dl]	0 and 8 weeks
Secondary	Changes in low-density lipoproteins levels over 8 weeks	Low-density lipoproteins are measured as a milligrams per decilitre [mg/dl]	0 and 8 weeks
Secondary	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.	0 and 8 weeks
Secondary	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-	0 and 8 weeks