Exercise for Postoperative Complications in Heart Surgery

(PRÉAD-CARDIAQU Trial)

Overseen By Silvanna Cardoso

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Montreal Heart Institute

Disqualifiers: Unstable angina, Malignant arrhythmias, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a home-based exercise program, called the Prehabilitation Program, can improve recovery for individuals awaiting heart surgery. Guided by a physiotherapist, the program includes exercises and breathing training that participants perform at home for 8 to 16 weeks before surgery. The trial will compare recovery outcomes between those who follow this program and those who receive standard care. Suitable candidates include individuals at high risk of surgery-related complications, with at least an 8-week wait before surgery, and who can participate in video calls. As an unphased trial, this study offers a unique opportunity to potentially enhance recovery with personalized, home-based care.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this exercise-based prehabilitation program is safe for patients awaiting heart surgery?

Researchers have found that exercise programs for patients awaiting heart surgery are generally safe. These programs, known as prehabilitation, involve structured exercises to aid recovery. Most participants handled the exercises well, with no major problems reported. Another study showed that these programs could reduce complications after surgery and help patients leave the hospital sooner. Thus, exercising before surgery can be safe and beneficial for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the prehabilitation program because it offers a proactive approach to reducing complications after heart surgery. Unlike traditional post-surgery rehabilitation, which begins after the procedure, this program starts before surgery and includes personalized exercise plans supervised by a physiotherapist. It uniquely combines breathing exercises, aerobic, and strengthening activities with regular follow-ups, aiming to enhance patients' strength and resilience before they even enter the operating room. This early intervention could potentially improve recovery outcomes and reduce hospital stays.

What evidence suggests that this prehabilitation program is effective for reducing postoperative complications in heart surgery?

Research shows that exercise programs before heart surgery can improve recovery. In this trial, participants in the Prehab group will engage in a supervised Prehabilitation Program, which includes individualized exercises. Studies have found that such programs can help patients walk farther and spend less time in the hospital after surgery. They are also likely to save money, particularly by preventing breathing problems. Prehabilitation includes personalized exercises that are safe and may reduce the risk of complications after surgery. Overall, this approach strengthens patients before surgery, leading to better recovery. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for people waiting for elective heart surgery who are at a higher risk of postoperative complications. They should be able to follow a home-based exercise program and commit to weekly meetings with a physiotherapist, either in person or via video call.

Inclusion Criteria

A high risk of perioperative and postoperative complications determined based on predictive thresholds

A waiting period of at least 8 weeks

Access to a smartphone, tablet, or computer for videoconference visits

Exclusion Criteria

I do not have recent severe heart problems or conditions.

I do not have any acute conditions affecting my vital signs or causing significant symptoms.

I have physical or mental limitations that prevent me from fully participating.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants take part in a personalized exercise program and breathing muscle training at home, supervised by a physiotherapist, for 8 to 16 weeks before surgery.

8-16 weeks

Weekly visits (in-person or virtual)

Postoperative Follow-up

Participants are monitored for safety and effectiveness after surgery, including assessments of postoperative recovery and complications.

10 days

During hospital stay

Long-term Follow-up

Comparison of postoperative recovery indicators between study participants and historical controls.

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Prehabilitation Program

Trial Overview The study tests if an 8-16 week personalized exercise program before heart surgery can improve recovery. It includes breathing muscle training and regular assessments by physiotherapists, comparing results with patients receiving standard care.

How Is the Trial Designed?

Group I: Prehab group Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Montreal Heart Institute

Lead Sponsor

Trials

125

Recruited

85,400+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07144722

Study Details | NCT07144722 | Prehabilitation Program for ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10010695/

Efficacy of Prehabilitation Before Cardiac Surgery The participation in exercise-based prehabilitation significantly improves postintervention and postsurgery 6-min walking distance, length of hospital stay, and ...

3. imrpress.com imrpress.com/journal/RCM/25/9/10.31083/j.rcm2509323/htm

A Three-Day Prehabilitation Program is Cost-Effective for ... The CEAC indicated that the prehabilitation program has a 92.6% and 93% probability of being cost-effective in preventing PPCs and improving ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1877065720301056

Effect of preparative rehabilitation on recovery after cardiac ... However, prehabilitation may improve postoperative functional capacity and slightly shorten the hospital stay (mean difference −0.66 days, 95% CI −1.29 to −0.03 ...

5. mdpi.com mdpi.com/2075-1729/14/7/832

A Review of Prehabilitation in Cardiac Surgery In patients awaiting elective cardiac surgery, structured exercise programs are safe and may decrease postoperative complications and hospital LOS [2,25]. 3.1.1 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8284810/

Prehabilitation to prevent complications after cardiac surgery Our analyses showed a significant decrease of AF in patients who followed prehabilitation compared to (matched) patients who did not follow prehabilitation. No ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1521689625000382

Prehabilitation and enhanced recovery after cardiac surgery The potential benefits include reduced complications, shorter hospital stays, improved recovery, and better patient outcomes. Future research should focus on ...

8. jacc.org jacc.org/doi/10.1016/j.jacc.2024.10.064

The Effect of Teleprehabilitation on Adverse Events After ... Teleprehabilitation also reduced the incidence of active smokers, elevated pulmonary risk scores, and elevated depression scores. There was no ...