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CABGpreHAB - a Feasibility Study Protocol

NCT07035171 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-06-29

No results posted yet for this study

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.

Conditions

  • Ischaemic Heart Disease
  • Prehabilitation
  • Coronary Artery Bypass
  • Feasibility Studies
  • Multimodal Intervention
  • Adult

Interventions

OTHER

Multimodal prehabilitation intervention

Multimodal prehabilitation interventions (CABGpreHAB): * Home-based exercise intervention delivered by a skilled physiotherapist via a web-based application. * Nutritional intervention * Psycho-educative intervention * Smoking cessation * Alcohol cessation

OTHER

Control (Standard treatment)

This includes standard information about CABG surgery, pre- and postoperative care, and postoperative physical activity advice. Patients are either admitted days before or on the day before surgery. They receive written materials and links to animated videos about preparing for surgery. This preparation includes counseling with a multidisciplinary team, including a department nurse, a physiotherapist, a cardiac anesthesiologist, and a surgeon.

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Ida E Hoejskov, PhD · Department of Heart Disease, Rigshospitalet, Copenhagen University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-24
Primary Completion
2026-06-18
Completion
2026-07-18

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07035171 on ClinicalTrials.gov