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

Not Applicable

Not yet recruiting

• Conditions: Cardiac Surgery; Prehabilitation; Postoperative Complications

• Registration Number: NCT07144722
• Lead Sponsor: Montreal Heart Institute

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-02
• Study First Submitted QC: 2025-08-20
• Last Update Submitted: 2025-08-20
• Study First Posted: 2025-08-27
• Last Update Posted: 2025-08-27
• Study Start: 2025-09-15
• Primary Completion: 2026-04-15
• Study Completion: 2026-06-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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").
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").

Secondary Outcome Measures

Name	Time	Method
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.
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.
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
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

Trial Locations

Locations (1)

Montreal Heart Institut; 🇨🇦 Montreal, Quebec, Canada