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

NCT07098039 | Not Yet Recruiting

• 1 other identifier: REG: 2023/PI0523
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cardiac rehabilitation; cardiovascular diseases; wearables

Outcome Measures

Primary Outcomes (1)

• Ergospirometry parameters and functional capacity

  Ergospirometry will be performed, in which the following parameters will be collected: VO2 peak (ml/Kg/min).

  Baseline and up to eight weeks.

Secondary Outcomes (28)

• Anthropometric data

  Baseline and up to eight weeks

• Heart rate

  Baseline and up to eight weeks

• Dyspnoea

  Baseline and up to eight weeks

• Biochemical parameters: HbA1c

  Baseline and up to eight weeks

• Muscle strength

  Baseline and up to eight weeks

Study Arms (2)

Hospital Cardiac rehabilitation

EXPERIMENTAL

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

Other: Hospital Cardiac Rehabilitation

Semi-presential or hibrid group

OTHER

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: Semi-presential or hybrid group

Interventions

Semi-presential or hybrid group OTHER

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.

Semi-presential or hibrid group

Hospital Cardiac Rehabilitation OTHER

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

Hospital Cardiac rehabilitation

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between the ages of 20 and 80.
• Have suffered an acute event or have chronic cardiovascular disease with decreased/limited functional capacity.
• Reside in the provinces of Cuenca, Toledo, or Albacete.
• Willingness to participate voluntarily and acceptance of the conditions.
• Must report the ability to access new technologies.

You may not qualify if:

• Have a physical or mental condition that prevents participation.
• Inability to adhere to the entire program, as reported in the initial consultation.
• Are outside the age criteria defined above.

Sponsors & Collaborators

• Hospital Virgen de la Luz: lead
• University of Castilla-La Mancha: collaborator

Study Sites (1)

Hospital Virgen de la Luz

Cuenca, Cuenca, 16002, Spain

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

Susana Priego Jiménez Physiotherapist, PhD

CONTACT

667855633; susiprie@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both the researchers who manage the data and include it in the database, as well as those who analyze it, will not know the intervention that the participants have received.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Diploma in physiotherapy, PhD in Socio-Health and Physical Activity Research from the UCLM International Doctoral School, with a distinction of OUTSTANDING CUM LAUDE.

Model Details: This project will have a prospective longitudinal design, specifically a randomized controlled trial.

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: August 1, 2025
• Study Start: September 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)