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Preoperative Strength-resistance Training in Valvular Heart Disease Patients

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05911191
Acronym
CardiacEBPhb
Enrollment
96
Registered
2023-06-20
Start date
2023-07-01
Completion date
2024-07-01
Last updated
2023-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise Based Prehabilitation in Valvular Surgery

Keywords

Physiotherapy, Muscular strengthening, Quality of life, Hospital stay

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.

Interventions

OTHERExercise based prehabilitation

A peripheral muscle strengthening program

Sponsors

Hospital de la Ribera
CollaboratorOTHER
University of Valencia
CollaboratorOTHER
Cardenal Herrera University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Masking description

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.

Intervention model description

A prospective, parallel, non-randomised, single-centre, clinical trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
length of stay in hospital1 yearlength of hospital stay from admission to discharge
Length of stay in ICU1 yearlength of ICU stay from admission until the transfer of the patient to his room
EuroQoL-5D1 yearPerception of quality of life

Secondary

MeasureTime frameDescription
Inspiratory capacity1 yearthe volume of air that can be inspired by the resting inspiratory position
Exercise capacity1 yearPatient's ability to perform physical exertion
Peak expiratory flow1 yearthe maximum flow that a person can exhale during a brief maximal expiratory effort after full inspiration
Respiratory pressures1 yearthe strength of the respiratory muscles, both at diaphragmatic (inspiratory) and abdominal and intercostal (expiratory) levels

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026