About this trial
The goal of this study is to learn if an exercise-based prehabilitation program can help people who are waiting for heart surgery and are at higher risk of complications recover better.
The main questions it aims to answer are:
Can a home-based prehabilitation program prescribed by a physiotherapist be done safely and realistically before heart surgery?
Participants will:
Take part in a personalized exercise program for a 8 to 16 weeks before surgery
Do breathing muscle training at home
Meet with a physiotherapist once a week, either in person or by video call
Be assessed before and after the program
Researchers will compare the postoperative results with those of patients who received usual care only.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A high risk of perioperative and postoperative complications. This risk is determined based on the predictive thresholds for postoperative complications.
A waiting period of at least 8 weeks.
Access to a smartphone, tablet, or computer for videoconference visits.
Disqualifiers
Unstable angina, malignant arrhythmias, active endocarditis/myocarditis, myocardial infarction within the last 2 weeks, left main coronary artery disease ≥ 50% on coronary angiography, severe aortic stenosis, severe mitral insufficiency, and decompensated heart failure.
Any other acute condition affecting vital signs or causing significant symptoms.
Physical or cognitive impairment limiting the ability to participate in the program.
Trial design
Single group
Treatments tested in this trial
Exercise
Other interventionWhat distinguishes this intervention from others is its hybrid delivery model, combining virtual more than in-person sessions to increase accessibility and adherence. Additionally, it incorporates specific inspiratory muscle training, which is often overlooked in standard prehabilitation programs, and emphasizes a personalized progression based on each participant's functional capacity and feedback. This tailored approach aims to optimize physical readiness before surgery while minimizing patient burden and travel requirements.
Treatment groups
Trial outcomes
Primary outcomes
Recruitment Rate (%)
Proportion of eligible candidates who enroll in the study. Recruitment rate will be calculated as the number of participants enrolled divided by the number of eligible candidates, multiplied by 100.
Adherence Rate (%)
Proportion of participants who complete at least 70% of prescribed exercise sessions. Calculated as the number of participants meeting this threshold divided by the total number enrolled, multiplied by 100.
Program Safety - number of participants experiencing exercise-related adverse events
Count of participants experiencing one or more adverse events during the program, including angina, arrhythmias, myocardial infarction, acute heart failure, or sudden cardiac death of cardiac origin.
Participant Satisfaction - likelihood to recommend
Among participants who complete the program, the self-reported likelihood of recommending the program to others, measured on a numeric rating scale from 0 ("not at all likely") to 10 ("extremely likely").
Secondary outcomes
Maximal Inspiratory Pressure (cmH2O)
Difference between post-program and baseline values of maximal inspiratory pressure, measured in centimeters of water (cmH₂O) using a digital manometer.
Diaphragm Thickening Fraction (%)
Difference between post-program and baseline diaphragm thickening fraction, calculated as (thickness at end-inspiration - thickness at end-expiration) / thickness at end-expiration × 100 using ultrasound.
Grip Strength (kg)
Difference between post-program and baseline grip strength, measured in kilograms using a handheld dynamometer
5-repetition-sit-to-stand Test - Lower Limb Strength (seconds)
Difference between post-program and baseline time to complete five repetitions of the sit-to-stand test, measured in seconds.
Other outcomes
Postoperative pulmonary complication - Exploratory Outcome Measures - Comparison of Postoperative Recovery Indicators Between Study Participants and Historical Controls
Proportion (%) of participants, based on historical patient data from a sample of the same population as the study participants and from the year preceding the start of the project, who experienced at least one postoperative pulmonary complication. This will be recorded as described for the same variable in the secondary outcomes.
Postoperative Recovery - Exploratory Outcome Measures - Comparison of Postoperative Recovery - Duration of Mechanical Ventilation - Between Study Participants and Historical Controls
Duration of postoperative mechanical ventilation (hours) collected from historical patient records of the same population.
Postoperative Recovery - Exploratory Outcome Measures - Comparison of Postoperative Recovery - Recovery of mobility (first mobilization out of the bed) - Between Study Participants and Historical Controls
Postoperative day of first mobilization out of bed collected from historical patient records of the same population.
Postoperative Recovery - Exploratory Outcome Measures - Comparison of Postoperative Recovery - Recovery of mobility (first ambulation) - Between Study Participants and Historical Controls
Postoperative day of first ambulation collected from historical patient records of the same population.
Sponsors and contacts
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