Cardiac Surgery, Postoperative Complications, Prehabilitation
Conditions
Keywords
exercise-based prehabilitation, pulmonary postoperative complications, teleprehabilitation, elective surgery, cardiac procedures
Brief summary
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.
Interventions
OTHERExercise
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.
Sponsors
Montreal Heart Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Satisfaction - likelihood to recommend | From enrollment to the end of treatment at maximum 16 weeks | 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). |
| Program Safety - number of participants experiencing exercise-related adverse events | From enrollment to the end of treatment at maximum 16 weeks | 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. |
| Adherence Rate (%) | From enrollment to the end of treatment at maximum 16 weeks | 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. |
| Participant Satisfaction - likelihood to repeat | From enrollment to the end of treatment at maximum 16 weeks | Among participants who complete the program, the self-reported likelihood of participating in the program again, measured on a numeric rating scale from 0 (not at all likely) to 10 (extremely likely). |
| Recruitment Rate (%) | From enrollment to the end of treatment at maximum 16 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 5-meter Gait Speed (seconds) | From enrollment to the end of treatment at maximum 16 weeks | Difference between post-program and baseline time to walk 5 meters, measured in seconds. |
| Number of participants with postoperative pulmonary complications | From the day of surgery through hospital discharge (average of 10 days) | Count of participants with at least one postoperative pulmonary complication during hospital stay, as defined by clinical diagnosis documented in the medical record. |
| Duration of postoperative mechanical ventilation (hours) | From ICU admission after surgery until extubation (within hospital stay, average 24-72 hours) | Time in hours from ICU admission to extubation |
| Recovery of Mobility - Postoperative day of first mobilization (day out of bed) | Un average of 1 - 3 days | Postoperative day number on which the participant first sits out of bed. |
| Recovery of Mobility - Postoperative day of first ambulation | An average of 3 - 6 days | Postoperative day number on which the participant first walks |
| Length of Postoperative Hospital Stay (days) | From the day of surgery through hospital discharge (average of 10 days) | Number of days from the date of surgery to hospital discharge |
| Functional Capacity - six-minute walk distance (meters) | From enrollment to the end of treatment at maximum 16 weeks | Difference between post-program and baseline walking distance achieved in the Six-Minute Walk Test (6MWT), measured in meters |
| Maximal Inspiratory Pressure (cmH2O) | From enrollment to the end of treatment at maximum 16 weeks | Difference between post-program and baseline values of maximal inspiratory pressure, measured in centimeters of water (cmH₂O) using a digital manometer. |
| Diaphragm Thickening Fraction (%) | From enrollment to the end of treatment at maximum 16 weeks | 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) | From enrollment to the end of treatment at maximum 16 weeks | 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) | From enrollment to the end of treatment at maximum 16 weeks | Difference between post-program and baseline time to complete five repetitions of the sit-to-stand test, measured in seconds. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pulmonary complication - Exploratory Outcome Measures - Comparison of Postoperative Recovery Indicators Between Study Participants and Historical Controls | The month following the completion of primary and secondary data collection | 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 - Length of Hospital Stay - Between Study Participants and Historical Controls | The month following the completion of primary and secondary data collection | Number of days from the date of surgery to hospital discharge 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 | The month following the completion of primary and secondary data collection | Postoperative day of first ambulation 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 | The month following the completion of primary and secondary data collection | 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 - Duration of Mechanical Ventilation - Between Study Participants and Historical Controls | The month following the completion of primary and secondary data collection | Duration of postoperative mechanical ventilation (hours) collected from historical patient records of the same population. |
Countries
Canada
Contacts
Primary ContactSilvanna Cardoso
Outcome results
None listed