NCT07035171 CABGpreHAB - a Feasibility Study Protocol
| NCT ID | NCT07035171 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rigshospitalet, Denmark |
| Condition | Ischaemic Heart Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-06-24 |
| Primary Completion | 2026-06-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-06-24 with a primary completion date of 2026-06-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Ida E Hoejskov, PhD
PRINCIPAL INVESTIGATOR
Department of Heart Disease, Rigshospitalet, Copenhagen University Hospital
Frequently Asked Questions
Who can join the NCT07035171 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ischaemic Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07035171 currently recruiting?
Yes, NCT07035171 is actively recruiting participants. Contact the research team at dorte.baek.olsen@regionh.dk for enrollment information.
Where is the NCT07035171 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT07035171 clinical trial?
NCT07035171 is sponsored by Rigshospitalet, Denmark. The principal investigator is Ida E Hoejskov, PhD at Department of Heart Disease, Rigshospitalet, Copenhagen University Hospital. The trial plans to enroll 50 participants.