Preoperative Strength-resistance Training in Valvular Heart Disease Patients

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Exercise Based Prehabilitation in Valvular Surgery

Intervention / Treatment
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* Other: Exercise based prehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective, parallel, non-randomised, single-centre, clinical trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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<br>Addittionally, a preoperative musculoskeletal and cardiopulmonary rehabilitation program focused on peripheral resistance training, will be implemented in the experimental group | Other: Exercise based prehabilitation<br>* A peripheral muscle strengthening program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of stay in hospital | length of hospital stay from admission to discharge | 1 year | 
| Length of stay in ICU | length of ICU stay from admission until the transfer of the patient to his room | 1 year | 
| EuroQoL-5D | Perception of quality of life | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inspiratory capacity | the volume of air that can be inspired by the resting inspiratory position | 1 year | 
| Peak expiratory flow | the maximum flow that a person can exhale during a brief maximal expiratory effort after full inspiration | 1 year | 
| Respiratory pressures | the strength of the respiratory muscles, both at diaphragmatic (inspiratory) and abdominal and intercostal (expiratory) levels | 1 year | 
| Exercise capacity | Patient's ability to perform physical exertion | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physiotherapy, Muscular strengthening, Quality of life, Hospital stay