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Clinical Trials/NCT05911191
NCT05911191
Not yet recruiting
Not Applicable

Can Resistance Training Bring Additional Benefits to a Cardiac Surgery Exercises Based Prehabilitation Program? Protocol for a Non-randomized Controlled Clinical Study of Valvular Heart Disease Patients. Cardiac EBPrehab.

Cardenal Herrera University1 site in 1 country96 target enrollmentJuly 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Exercise Based Prehabilitation in Valvular Surgery
Sponsor
Cardenal Herrera University
Enrollment
96
Locations
1
Primary Endpoint
Length of stay in ICU
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2023
End Date
July 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Cardenal Herrera University
Responsible Party
Principal Investigator
Principal Investigator

JORGE MONTERO CÁMARA

PhD Student

Cardenal Herrera University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Length of stay in ICU

Time Frame: 1 year

length of ICU stay from admission until the transfer of the patient to his room

length of stay in hospital

Time Frame: 1 year

length of hospital stay from admission to discharge

EuroQoL-5D

Time Frame: 1 year

Perception of quality of life

Secondary Outcomes

  • Peak expiratory flow(1 year)
  • Respiratory pressures(1 year)
  • Exercise capacity(1 year)
  • Inspiratory capacity(1 year)

Study Sites (1)

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