Preoperative Strength-resistance Training in Valvular Heart Disease Patients (CardiacEBPhb)

Cardenal Herrera University

Status: Not yet enrolling

Conditions: Exercise Based Prehabilitation in Valvular Surgery

Treatments: Other: Exercise based prehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05911191

PI 04-05/23

Details and patient eligibility

About

Cardiovascular diseases (CVD) are a group of illnesses that include coronary heart disease, cerebrovascular disease, congenital heart disease, and deep vein thrombosis. CVD is the leading cause of mortality worldwide, representing 31% of deaths. In Spain, CVD caused 24% of all deaths in 2020. Major surgery is often chosen as the treatment of choice for CVD. The concept of fast-track rehabilitation after surgery appeared in the 1970s. Participation in these exercise-based prehabilitation programs may decrease postoperative complications and length of hospital stay.

The purpose of the present study is to evaluate whether the implementation of an additional resistance training (RT) prehabilitation protocol within a cardiac exercise-based prehabilitation can reduce ICU length of stay, postoperative complications, and hospital length of stay (LOS). Additionally, the secondary objective is to determine whether a program that includes RT in addition to respiratory and aerobic training can have better effects on ventilatory variables.

This study follows the protocol of a prospective, parallel, non-randomized clinical trial. Ninety-six adult patients diagnosed with valvular pathology and who have been scheduled for surgery will be included. The control group will be treated with ventilatory and strengthening of respiratory muscles, as well as aerobic exercise. The experimental group, in addition, will receive RT targeting peripheral muscles. Variables such as hospital stay, quality of life, respiratory values, and exercise capacity will be evaluated. Quantitative variables will be analyzed using a t-test or ANOVA, or Mann-Whitney test if the distribution is non-parametric.

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients diagnosed with valvular pathology who have been admitted as candidates for cardiac surgery for the first time, and who have been scheduled for surgery

Exclusion criteria

• stage 4 or 5 renal failure, low ejection fraction, Euroscore greater than 15 (Nashef et al., 2012) , non-ST-segment elevation acute coronary syndrome (NSTEACS), coronary artery disease, or need for urgent intervention

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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96 participants in 2 patient groups

Control

No Intervention group

Description:

Both groups will receive a first session in which they will be instructed to carry out the unsupervised home EBPrehab program, consisting of respiratory training, ventilatory training, strengthening of the respiratory muscles, aerobic endurance exercise through continuous walking, and a series of recommendationss on post-surgical care

Experimental

Experimental group

Description:

Addittionally, a preoperative musculoskeletal and cardiopulmonary rehabilitation program focused on peripheral resistance training, will be implemented in the experimental group

Treatment:

Other: Exercise based prehabilitation