WithdrawnNot Applicable

PRehabilitiation in Elective Frail and Elderly Cardiac Surgery PaTients

Stopped: Due to a reduction in surgical wait times, there was insufficient time to complete the intervention prior to surgery.

Canada0Started 2018-05-20

Plain-language summary

Older and more frail adults are more often being referred for cardiac surgery. These patients are often in suboptimal health, and may be physically frail, malnourished, and have other conditions, such as diabetes, that complicate their recovery. Research suggests that a rehabilitation program prior to surgery may help improve participants' health and improve their fitness for surgery. Currently, a pre-operative rehabilitation workshop is offered at the University of Ottawa Heart Institute, but this interventional, randomized study will investigate whether a more comprehensive pre-operative regime, including structured weekly exercise program, is more effective at improving health prior to surgery. Patients will be randomized to either the control group (pre-operative rehabilitation workshop ONLY) or the treatment group (pre-operative rehabilitation workshop plus exercise regime). This regime will attempt to improve patients' overall health, including their physical fitness and nutritional status. The effectiveness of this regime will be evaluated by comparing patients' physical function, questionnaires (diet, quality of life, stress) and serum biomarkers from baseline to pre-surgery to post-surgery. The Investigators hypothesize that patients that complete the pre-operative rehabilitation program will improve their health prior to surgery, and that this may result in shorter length of hospitalization and fewer complications after surgery. The study will take place over two years, with each patient's participation lasting about 3 months.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients \>18 years of age * Patients able to provide informed consent * Patients undergoing elective cardiac surgery for either CABG, valve, or CABG + valve * Patients who have an estimated wait time of at least 10 weeks. * Patients who are either ≥65 years of age or classified as frail using Fried Frailty criteria or scoring at least 3 on the Clinical Frailty Scale Exclusion Criteria: * Patients with current or recent unstable cardiac disease, defined as and of the following: * CCS class IV angina, * NYHA Class III or IV heart failure, * Critical left main disease, * hospitalization for arrhythmia within the last month * Dynamic ventricular outflow obstruction * Symptomatic exercise-induced arrhythmia * Patients who are cognitively, geographically or physically unable to complete the PREHAB sessions * Patients who, in the opinion of either their treating physician or the study investigators, should not participate in a pre-operative rehabilitation program.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Functional capacity

Timeframe: Change between baseline and 8 weeks (+/- 1 week)

Trial details

NCT IDNCT03399162

SponsorOttawa Heart Institute Research Corporation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-05-01

View on ClinicalTrials.gov More Coronary Artery Disease trials