Prehabilitation Program for Patients Awaiting Elective Heart Surgery at Increased Risk of Postoperative Complications: Feasibility and Potential Clinical Outcomes

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMontreal Heart Institute

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Exercise

    Other intervention

    What 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

45 Participants
are divided into 1 treatment group
Group A: Prehab groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to the end of treatment at maximum 16 weeks
2

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.

Time frame
From enrollment to the end of treatment at maximum 16 weeks
3

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.

Time frame
From enrollment to the end of treatment at maximum 16 weeks
4

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").

Time frame
From enrollment to the end of treatment at maximum 16 weeks

Secondary outcomes

1

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.

Time frame
From enrollment to the end of treatment at maximum 16 weeks
2

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.

Time frame
From enrollment to the end of treatment at maximum 16 weeks
3

Grip Strength (kg)

Difference between post-program and baseline grip strength, measured in kilograms using a handheld dynamometer

Time frame
From enrollment to the end of treatment at maximum 16 weeks
4

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.

Time frame
From enrollment to the end of treatment at maximum 16 weeks

Other outcomes

1

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.

Time frame
The month following the completion of primary and secondary data collection
2

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.

Time frame
The month following the completion of primary and secondary data collection
3

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.

Time frame
The month following the completion of primary and secondary data collection
4

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.

Time frame
The month following the completion of primary and secondary data collection

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: