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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prehab group | Experimental | Supervised by a physiotherapist, the program includes an initial functional assessment, individualized training (breathing exercises, aerobic and strengthening exercises), and weekly follow-up via videoconference or phone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at maximum 16 weeks |
| 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. | From enrollment to the end of treatment at maximum 16 weeks |
| 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. | From enrollment to the end of treatment at maximum 16 weeks |
| 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"). | From enrollment to the end of treatment at maximum 16 weeks |
| Participant Satisfaction - likelihood to repeat | 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"). | From enrollment to the end of treatment at maximum 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of treatment at maximum 16 weeks |
| Diaphragm Thickening Fraction (%) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Silvanna Cardoso | Contact | 15143763330 | 3441 | silvanna.cardoso@icm-mhi.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montreal Heart Institut | Montreal | Quebec | H1T1C8 | Canada |
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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. |
| From enrollment to the end of treatment at maximum 16 weeks |
| Grip Strength (kg) | Difference between post-program and baseline grip strength, measured in kilograms using a handheld dynamometer | From enrollment to the end of treatment at maximum 16 weeks |
| 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. | From enrollment to the end of treatment at maximum 16 weeks |
| 5-meter Gait Speed (seconds) | Difference between post-program and baseline time to walk 5 meters, measured in seconds. | From enrollment to the end of treatment at maximum 16 weeks |
| Functional Capacity - six-minute walk distance (meters) | Difference between post-program and baseline walking distance achieved in the Six-Minute Walk Test (6MWT), measured in meters | From enrollment to the end of treatment at maximum 16 weeks |
| Number of participants with postoperative pulmonary complications | Count of participants with at least one postoperative pulmonary complication during hospital stay, as defined by clinical diagnosis documented in the medical record. | From the day of surgery through hospital discharge (average of 10 days) |
| Duration of postoperative mechanical ventilation (hours) | Time in hours from ICU admission to extubation | From ICU admission after surgery until extubation (within hospital stay, average 24-72 hours) |
| Recovery of Mobility - Postoperative day of first mobilization (day out of bed) | Postoperative day number on which the participant first sits out of bed. | Un average of 1 - 3 days |
| Recovery of Mobility - Postoperative day of first ambulation | Postoperative day number on which the participant first walks | An average of 3 - 6 days |
| Length of Postoperative Hospital Stay (days) | Number of days from the date of surgery to hospital discharge | From the day of surgery through hospital discharge (average of 10 days) |
| The month following the completion of primary and secondary data collection |
| 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. | The month following the completion of primary and secondary data collection |
| 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. | The month following the completion of primary and secondary data collection |
| 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. | The month following the completion of primary and secondary data collection |
| Postoperative Recovery - Exploratory Outcome Measures - Comparison of Postoperative Recovery - Length of Hospital Stay - Between Study Participants and Historical Controls | Number of days from the date of surgery to hospital discharge collected from historical patient records of the same population. | The month following the completion of primary and secondary data collection |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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