Clinical trial NCT05911191: Preoperative Strength-resistance Training in Valvular Heart Disease Patients
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Exercise Based Prehabilitation in Valvular Surgery
Keywords: Physiotherapy
Muscular strengthening
Quality of life
Hospital stay
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
Collaborators: name: Hospital de la Ribera
name: University of Valencia
First posted: 2023-06-20
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, parallel, non-randomised, single-centre, clinical trial
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: length of stay in hospital
timeFrame: 1 year
measure: Length of stay in ICU
timeFrame: 1 year
measure: EuroQoL-5D
timeFrame: 1 year
Secondary outcomes:
measure: Inspiratory capacity
timeFrame: 1 year
measure: Peak expiratory flow
timeFrame: 1 year
measure: Respiratory pressures
timeFrame: 1 year
measure: Exercise capacity
timeFrame: 1 year
Other outcomes:
Locations:
city: Alzira
country: Spain
facility: Hospital Universitario de La Ribera, Alzira
state: Valencia
Study officials:
References: