Cardio-Fit2: Impact of a Cardiac Rehabilitation Program in Patients With Cardiovascular Disease

NCT07098039 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-08-01

No results posted yet for this study

Summary

Cardiovascular diseases (CVD) are the main cause of morbidity and mortality in the world, being responsible for 17.9 million deaths annually, according to the World Heart Federation (WHF), which represents a significant social and health cost both due to direct expenses derived from admissions and diagnostic-therapeutic methods, as well as indirect expenses secondary to work incapacity, disability and loss of autonomy that this generates. Although advanced diagnostic and therapeutic techniques have been incorporated in recent years in the acute phase of ischemic heart disease, interventions during hospitalization and after hospital discharge remain insufficient in terms of secondary prevention, a paradoxical fact, since increasingly, the available evidence, as well as the recommendation guidelines, focus on the modification of lifestyle habits and control of cardiovascular risk factors (CVRF), fundamental pillars of cardiac rehabilitation programs (PRC) as a preventive measure both in the appearance of new adverse events and in the reduction of disease progression and improvement of the functional capacity of the patient. Cardiac rehabilitation (CR) was defined by the World Health Organization (WHO) in the 1960s as "the set of activities necessary to ensure that heart patients have an optimal physical, mental and social condition, allowing them to occupy, by their own means, as normal a place as possible in society." The scientific evidence is more than consistent regarding the benefits that multidisciplinary CRP provides in terms of cardiovascular mortality and quality of life (QoL) of our patients and how these results are maintained despite changes in patient characteristics and risk, or the incorporation of new pharmacological treatments. Therefore, if we deprive our patients of these therapies, we are indirectly acting negatively on their cardiovascular prognosis, especially within the field of ischemic heart disease, although it is increasingly being extended to other areas of Cardiology such as heart failure (HF), pulmonary hypertension (PH), valvular disease,7 etc. So much so that it is already included in the latest clinical practice guidelines of the main scientific societies at European and American level, establishing participation in a CR program after acute coronary syndrome or coronary revascularization and those patients with HF as a "level of recommendation I evidence A"

Conditions

  • Cardiovascular Diseases (CVD)
  • Cardiac Rehabilitation

Interventions

OTHER

Semi-presential or hybrid group

The hybrid format will consist of 4 in-person sessions (every two weeks) complemented by a home program until completing 3 sessions of the full program at home.

OTHER

Hospital Cardiac Rehabilitation

The hospital cardiac rehabilitation group will attend the hospital 3 days a week for the same, for eight weeks.

Sponsors & Collaborators

  • University of Castilla-La Mancha

    collaborator OTHER
  • Hospital Virgen de la Luz

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2025-11-30
Completion
2025-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07098039 on ClinicalTrials.gov