CClinicalTrials.gg
Not yet recruitingNCT07144722PRÉAD-CARDIAQUUpdated Aug 27, 2025

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

An interventional study of Exercise in Cardiac Surgery, Prehabilitation and Postoperative Complications, sponsored by Montreal Heart Institute. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-27.

Sponsored by Montreal Heart Institute · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Apr 2026, 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cardiac Surgery
  • Prehabilitation
  • Postoperative Complications

Keywords

  • exercise-based prehabilitation
  • pulmonary postoperative complications
  • teleprehabilitation
  • elective surgery
  • cardiac procedures
03

In context

Postoperative Complications

1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.

This study's planned enrollment of 45 is below the median of 119 across 689 interventional studies indexed under Postoperative Complications.

Browse Postoperative Complications studies →

Lead sponsor

Montreal Heart Institute is the lead sponsor of 101 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    Prehab group

    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.

    Other: Exercise

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.

    Also known as: Inspiratory muscle training

06

What researchers measure

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

  5. 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").

    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

  5. 5-meter Gait Speed (seconds)

    Difference between post-program and baseline time to walk 5 meters, measured in seconds.

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

  6. 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

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

  7. 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.

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

  8. Duration of postoperative mechanical ventilation (hours)

    Time in hours from ICU admission to extubation

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

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

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

    Time frame: Un average of 1 - 3 days

  10. Recovery of Mobility - Postoperative day of first ambulation

    Postoperative day number on which the participant first walks

    Time frame: An average of 3 - 6 days

  11. Length of Postoperative Hospital Stay (days)

    Number of days from the date of surgery to hospital discharge

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

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

  5. 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.

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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07144722
Lead sponsor
Montreal Heart Institute
Responsible party
Andre Denault (Anesthésiologiste, Montreal Heart Institute) — Principal investigator
First posted
Aug 27, 2025
Start date
Sep 15, 2025 (estimated)
Primary completion
Apr 15, 2026 (estimated)
Completion
Jun 15, 2026 (estimated)
Last update
Aug 27, 2025

Study contacts

Silvanna Cardoso
Contact
silvanna.cardoso@icm-mhi.org
15143763330 ext. 3441

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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