RecruitingNot Applicable

CABGpreHAB - a Feasibility Study Protocol

Denmark50 participantsStarted 2025-06-24

Plain-language summary

Patients with ischemic heart disease (IHD) awaiting coronary artery bypass graft (CABG) surgery often face challenges like advanced age, frailty, comorbidities, and physical inactivity. These factors, combined with the physiological and psychological stress of surgery, can hinder postoperative recovery. Traditionally, strategies to improve surgical outcomes focus on the intra- and postoperative periods. However, the pre-surgery waiting period offers a "window of opportunity" for prehabilitation, which aims to enhance patients' functional capacity through exercise, nutrition, and psychological support. The CABGpreHAB feasibility study evaluates the feasibility of a home-based multimodal prehabilitation intervention for patients awaiting elective CABG surgery. This randomized pilot study compares the intervention plus usual care to usual care alone, assessing feasibility outcomes like recruitment, retention, attrition, fidelity, and adherence. The study aims to optimize a subsequent full-scale randomized controlled trial (RCT) and improve patient outcomes by leveraging the pre-surgery period for prehabilitation.

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: * Planned to have elective isolated first-time CABG surgery. * 18 years or older * Two weeks or more before surgery * Speaks and understands Danish. * Gives written informed consent. Exclusion Criteria: * Patient with unstable angina pectoris and/ or MI during the last two weeks. * Left main stem stenosis \>50% * Left ventricular ejection fraction \< 35% * Significant ventricular arrhythmia * Orthopedic or neurologic preconditions precluding exercise training. * Inability to attend the prehabilitation program due to physical limitations. * Patients who have cognitive deficits that would disqualify prehabilitation. * Severe heart failure, NYHA Class IV * Lack of capacity to consent

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

Feasibility outcome: recruitement rate

Timeframe: Through study completition, an average of 1 year

Feasibility outcome: Attrition rates

Timeframe: Up to 30 days post surgery index

Feasibility outcome: Fidelity

Timeframe: preoperative

Feasibility outcome: Adherence rates

Timeframe: Preoperative

Feasibility outcome: Safety

Timeframe: From enrolement to the day before surgery

Trial details

NCT IDNCT07035171

SponsorRigshospitalet, Denmark

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-18

Contact for this trial

Dorte Baek Olsen, PhD student

+4526625705 dorte.baek.olsen@regionh.dk

View on ClinicalTrials.gov More Ischaemic Heart Disease trials