Prehabilitation for Patients Undergoing Elective Cardiac Surgery

NCT07704086 | Completed

• 1 other identifier: PRECICA
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this clinical trial is to develop a novel rehabilitation model that, through the PRECICA program, will help to reduce perioperative and postoperative complications in the care process prior to planned cardiac surgery. This will be achieved by reducing the total postoperative hospital stay and the physical and psychological complications resulting from surgery. The target population for this trial is patients undergoing planned cardiac surgery due to chronic coronary artery disease, valvular pathology, chronic thromboembolic pulmonary hypertension and/or aortic injury. Consequently, the quality of life of these patients could be enhanced.

Conditions

Coronary Artery Disease; Valvular Heart Disease; Chronic Thromboembolic Pulmonary Hypertension; Aortic Diseases

Outcome Measures

Primary Outcomes (2)

• Six minute walk test

  A functional capacity test (six-minute walk test) will be conducted to assess the subject's cardiovascular capacity.

  This variable will be measured at four different time points; in the inclusion of the patient in the study, on the day of admission prior to surgery, one week after hospital discharge, and 2 months after surgery.

• Quality of life (EQ-5D-5L)

  The standard of health experienced

  This variable will be measured at four different time points; in the inclusion of the patient in the study, on the day of admission prior to surgery, one week after hospital discharge, and 2 months after surgery.

Secondary Outcomes (1)

• Period of hospitalization

  Through study completion, an average of 1 year

Study Arms (2)

Prehabilitation

EXPERIMENTAL

Other: Physical exercise; Other: Educational program and respiration physiotherapy

Standard care

OTHER

The standard of care is defined as a health education program and education in respiratory physiotherapy techniques.

Other: Educational program and respiration physiotherapy

Interventions

Physical exercise OTHER

A program designed to enhance muscular strength through a structured exercise program.

Prehabilitation

Educational program and respiration physiotherapy OTHER

The program will include a health education component and respiratory physiotherapy techniques.

Prehabilitation; Standard care

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 years or older.
• Scheduled for elective cardiac surgery for one or more of the following indications:
• Coronary artery disease.
• Valvular heart disease.
• Chronic thromboembolic pulmonary hypertension.
• Aortic disease.

You may not qualify if:

• \- Cognitive impairment that prevents understanding the study procedures or completing the intervention.

Sponsors & Collaborators

• Hospital Universitario 12 de Octubre: lead

Study Sites (2)

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

Universidad Complutense de Madrid

Madrid, Madrid, Spain

Location

MeSH Terms

Conditions

Coronary Artery Disease; Heart Valve Diseases; Aortic Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Therapist

Model Details: Prehabilitation in Cardiac Surgery, which will consist of a health education program, respiratory physiotherapy techniques, a health education program, and a peripheral muscle strength program.

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: July 15, 2026
• Study Start: June 1, 2024
• Primary Completion: June 1, 2026
• Study Completion: July 10, 2026
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)