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NCT Number: NCT07144722

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

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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Key information

Conditions

Cardiac Surgery Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Prehabilitation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Inspiratory muscle training

Primary outcomes

  1. Recruitment Rate (%)

    Time frame: 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.

  2. Adherence Rate (%)

    Time frame: 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.

  3. Program Safety - number of participants experiencing exercise-related adverse events

    Time frame: 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.

  4. Participant Satisfaction - likelihood to recommend

    Time frame: 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").

  5. Participant Satisfaction - likelihood to repeat

    Time frame: 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 outcomes

  1. Maximal Inspiratory Pressure (cmH2O)

    Time frame: 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.

  2. Diaphragm Thickening Fraction (%)

    Time frame: 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.

  3. Grip Strength (kg)

    Time frame: 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

  4. 5-repetition-sit-to-stand Test - Lower Limb Strength (seconds)

    Time frame: 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. 5-meter Gait Speed (seconds)

    Time frame: 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.

  6. Functional Capacity - six-minute walk distance (meters)

    Time frame: 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

  7. Number of participants with postoperative pulmonary complications

    Time frame: 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.

  8. Duration of postoperative mechanical ventilation (hours)

    Time frame: From ICU admission after surgery until extubation (within hospital stay, average 24-72 hours)

    Time in hours from ICU admission to extubation

  9. Recovery of Mobility - Postoperative day of first mobilization (day out of bed)

    Time frame: Un average of 1 - 3 days

    Postoperative day number on which the participant first sits out of bed.

  10. Recovery of Mobility - Postoperative day of first ambulation

    Time frame: An average of 3 - 6 days

    Postoperative day number on which the participant first walks

  11. Length of Postoperative Hospital Stay (days)

    Time frame: From the day of surgery through hospital discharge (average of 10 days)

    Number of days from the date of surgery to hospital discharge

Other outcomes

  1. Postoperative pulmonary complication - Exploratory Outcome Measures - Comparison of Postoperative Recovery Indicators Between Study Participants and Historical Controls

    Time frame: 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.

  2. Postoperative Recovery - Exploratory Outcome Measures - Comparison of Postoperative Recovery - Duration of Mechanical Ventilation - Between Study Participants and Historical Controls

    Time frame: 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.

  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

    Time frame: 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.

  4. Postoperative Recovery - Exploratory Outcome Measures - Comparison of Postoperative Recovery - Recovery of mobility (first ambulation) - Between Study Participants and Historical Controls

    Time frame: 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.

  5. Postoperative Recovery - Exploratory Outcome Measures - Comparison of Postoperative Recovery - Length of Hospital Stay - Between Study Participants and Historical Controls

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Silvanna Cardoso

CONTACT

[email protected]

15143763330 ext. 3441

Sponsors and collaborators

Lead sponsor

Montreal Heart Institute

Other

Registry information

Official study title

Preliminary Evaluation of a Prehabilitation Program for Adults Awaiting Elective Heart Surgery and at Increased Risk of Postoperative Complications

Acronym: PRÉAD-CARDIAQU

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2025
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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