NCT06127537

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 27, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2024

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

2.3 years

First QC Date

September 27, 2023

Last Update Submit

November 7, 2023

Conditions

Cardiac Rehabilitation

Keywords

Quality of LifeCardiovascular DiseaseHealth Education

Outcome Measures

Primary Outcomes (14)

  • 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

  • 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

  • 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

  • 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

  • Changes in maximum prehensile strength over 8 weeks

    Changes in maximal upper limb prehensile strength by dynamometry (kg).

    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).

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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).

    0 and 8 weeks

Secondary Outcomes (25)

  • Changes in body weight composition over 8 weeks

    0 and 8 weeks

  • Changes in body fat mass composition over 8 weeks

    0 and 8 weeks

  • Changes in body fat-free mass composition over 8 weeks

    0 and 8 weeks

  • Changes in estimated total body water composition over 8 weeks

    0 and 8 weeks

  • Changes in protein composition over 8 weeks

    0 and 8 weeks

  • +20 more secondary outcomes

Study Arms (2)

Control Group

NO INTERVENTION

Health Education Programme in cardiac rehabilitation without a Therapeutic Intervention Group

Experimental Group

EXPERIMENTAL

Health Education Programme in cardiac rehabilitation with a Therapeutic Intervention Group

Behavioral: Therapeutic Intervention Group

Interventions

Therapeutic Intervention GroupBEHAVIORAL

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.

Experimental Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Servicio Extremeño de Salud

Badajoz, 06006, Spain

RECRUITING

MeSH Terms

Conditions

Cardiovascular DiseasesHealth Education

Condition Hierarchy (Ancestors)

Adherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Francisco J Rodríguez Velasco, PhD

    University of Extremadura

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francisco J Rodríguez Velasco, PhD

CONTACT

+34 924289839fcorodriguezv@unex.es

Guadalupe Gil Fernández, PhD

CONTACT

+34 924489674ggilfer@unex.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor PhD, University of Extremadura

Study Record Dates

First Submitted

September 27, 2023

First Posted

November 13, 2023

Study Start

October 1, 2021

Primary Completion

January 31, 2024

Study Completion

June 16, 2024

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)