Cardiac SurgeryPRÉAD-CARDIAQUNCT07144722
Prehabilitation Program for Patients Awaiting Elective Heart Surgery at Increased Risk of Postoperative Complications: Feasibility and Potential Clinical Outcomes
A study testing Exercise in people with Cardiac Surgery and Prehabilitation, run by Montreal Heart Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Prehabilitation, Postoperative Complications
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 15 Sep 2025to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Montreal Heart Institut
Montreal, Quebec, H1T1C8
Silvanna Cardoso, 15143763330 ext. 3441, silvanna.cardoso@icm-mhi.org
About this study
Official title: Preliminary Evaluation of a Prehabilitation Program for Adults Awaiting Elective Heart Surgery and at Increased Risk of Postoperative Complications
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:
Read more
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.
- Being tested
- Exercise
- Keywords
- exercise-based prehabilitation, pulmonary postoperative complications, teleprehabilitation, elective surgery, cardiac procedures
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called Inspiratory muscle training
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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").
Measured: 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").
Measured: From enrollment to the end of treatment at maximum 16 weeks
Secondary outcomes (11)
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.
Measured: From enrollment to the end of treatment at maximum 16 weeks
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: Un average of 1 - 3 days
Recovery of Mobility - Postoperative day of first ambulation
Postoperative day number on which the participant first walks
Measured: An average of 3 - 6 days
Length of Postoperative Hospital Stay (days)
Number of days from the date of surgery to hospital discharge
Measured: From the day of surgery through hospital discharge (average of 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start15 Sep 2025 (estimated)
- Primary completion15 Apr 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre Denault, Montreal Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144722
- Sponsor's protocol ID
- 2025-3527
- Acronym
- PRÉAD-CARDIAQU
- Status last verified
- Aug 2025
- First submitted
- 2 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Evaluation of a Prehabilitation Program for Adults Awaiting Elective Heart Surgery and at Increased Risk of Postoperative Complications
- ClinicalTrials.gov ID
- NCT07144722
- Acronym / sponsor ID
- PRÉAD-CARDIAQU / 2025-3527
- Keywords
- exercise-based prehabilitation, pulmonary postoperative complications, teleprehabilitation, elective surgery, cardiac procedures
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 15 Apr 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 27 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prehab group | Experimental | Other: ExerciseSupervised 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: Inspiratory muscle trainingWhat 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 | Prehab group |
Primary outcome
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.
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.
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.
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").
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").
11 secondary outcomes
Maximal Inspiratory Pressure (cmH2O)
Time frame: From enrollment to the end of treatment at maximum 16 weeks
Diaphragm Thickening Fraction (%)
Time frame: From enrollment to the end of treatment at maximum 16 weeks
Grip Strength (kg)
Time frame: From enrollment to the end of treatment at maximum 16 weeks
5-repetition-sit-to-stand Test - Lower Limb Strength (seconds)
Time frame: From enrollment to the end of treatment at maximum 16 weeks
5-meter Gait Speed (seconds)
Time frame: From enrollment to the end of treatment at maximum 16 weeks
Functional Capacity - six-minute walk distance (meters)
Time frame: From enrollment to the end of treatment at maximum 16 weeks
Number of participants with postoperative pulmonary complications
Time frame: From the day of surgery through hospital discharge (average of 10 days)
Duration of postoperative mechanical ventilation (hours)
Time frame: 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)
Time frame: Un average of 1 - 3 days
Recovery of Mobility - Postoperative day of first ambulation
Time frame: An average of 3 - 6 days
Length of Postoperative Hospital Stay (days)
Time frame: From the day of surgery through hospital discharge (average of 10 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Cardiac Surgery and Prehabilitation, run by Montreal Heart Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvanna Cardoso (15143763330 ext. 3441, silvanna.cardoso@icm-mhi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (%) (time frame: From enrollment to the end of treatment at maximum 16 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.