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Not yet recruiting NCT07144722

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

No phase Interventional Cardiac Surgery Prehabilitation Postoperative Complications

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise.
Who it may be relevant to
Registry conditions: Cardiac Surgery, Prehabilitation, Postoperative Complications. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other Exercise
    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 patien

Primary outcome measures

  • Recruitment Rate (%) [Time frame: From enrollment to the end of treatment at maximum 16 weeks]
  • Adherence Rate (%) [Time frame: From enrollment to the end of treatment at maximum 16 weeks]
  • Program Safety - number of participants experiencing exercise-related adverse events [Time frame: From enrollment to the end of treatment at maximum 16 weeks]
  • Participant Satisfaction - likelihood to recommend [Time frame: From enrollment to the end of treatment at maximum 16 weeks]
  • Participant Satisfaction - likelihood to repeat [Time frame: From enrollment to the end of treatment at maximum 16 weeks]
Secondary outcome measures (11)
  • 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

Canada · 1 center
  • Montreal Heart Institut — Montreal

Identifiers

NCT: NCT07144722 · 2025-3527

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗