Preoperative Strength-resistance Training in Valvular Heart Disease Patients

NCT05911191 | Unknown

• 1 other identifier: PI 04-05/23
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise Based Prehabilitation in Valvular Surgery

Keywords

Physiotherapy; Muscular strengthening; Quality of life; Hospital stay

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Inspiratory capacity

  1 year

• Peak expiratory flow

  1 year

• Respiratory pressures

  1 year

• Exercise capacity

  1 year

Study Arms (2)

Control

NO INTERVENTION

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

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

Other: Exercise based prehabilitation

Interventions

Exercise based prehabilitation OTHER

A peripheral muscle strengthening program

Experimental

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardenal Herrera University: lead
• Hospital de la Ribera: collaborator
• University of Valencia: collaborator

Study Sites (1)

Hospital Universitario de La Ribera, Alzira

Alzira, Valencia, 46600, Spain

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: None of the evaluators or caregivers will know the group assignment of each participant. The person responsible for analyzing the data will only see on the data sheet whether they belong to group 1 or group 0, but they will not know which group each of the values is assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Model Details: A prospective, parallel, non-randomised, single-centre, clinical trial

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 20, 2023
• Study Start: July 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: June 20, 2023

Record last verified: 2023-06

Locations

ES (1)