CABGpreHAB - a Feasibility Study Protocol

NCT07035171 | Recruiting DMC

• 1 other identifier: Rigshospitalet Copenhagen
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Prehabilitation, CABG surgery, adult, preoperative,homebased

Outcome Measures

Primary Outcomes (5)

• Feasibility outcome: recruitement rate

  Determined by the number of individuals participating in the study out of those eligible during the inclusion period.

  Through study completition, an average of 1 year

• Feasibility outcome: Attrition rates

  Defined by the numbers of individuals who give consent to participate, but drop out before study ends.

  Up to 30 days post surgery index

• Feasibility outcome: Fidelity

  Fidelity of delivery on the web-based exercise training intervention will be assessed qualitatively by semi-structured interviews

  preoperative

• Feasibility outcome: Adherence rates

  Adherence will be assessed by measuring the number of telephone counseling and exercise sessions delivered during the intervention period.

  Preoperative

• Feasibility outcome: Safety

  Safety of the intervention will be determined based on the number and nature of adverse events.

  From enrolement to the day before surgery

Secondary Outcomes (14)

• Exercise capacity

  Three times: at baseline, preoperative and 30 days post surgery index

• Muscle strength

  Three times: at baseline, preoperative and 30 days post surgery index

• Muscle strength handgrip

  At baseline and preoperative

• Bodycomposition

  At baseline and preoperative

• Nutritional status

  At baseline and preoperative

Other Outcomes (6)

• Complications postoperatively

  From date of surgery and up to 30 days postopetively.

• ICU-LOS

  From date and time of surgery until the date and time of discharge to the ward.

• LOS

  From date of surgery until date of discharge from the ward

Study Arms (2)

CABGpreHAB multimodal prehabilitation intervention + usual care

EXPERIMENTAL

Patients randomized to the multimodal prehabilitation programme will, besides usual care, receive home-based preoperative interventions that consist of: Web-based exercise intervention supervised by skilled physiotherapists and delivered via a tablet. Each session lasts 60 minutes, three times per week for the prehabilitation period. Patients will be instructed to perform daily exercise tasks such as brisk walking and sit-to-stand exercises. Phone call and consultation delivered by a specialised nurse once a week. This consultation will deliver psychosocial support, equipping patients with coping strategies to mitigate stress, anxiety, and depression. Furthermore, nutritional advice will take place at these consultations, as well as advice on smoking cessation and alcohol cessation.

Other: Multimodal prehabilitation intervention

Control group

OTHER

Participants assigned to the control group will receive usual care.

Other: Control (Standard treatment)

Interventions

Multimodal prehabilitation intervention OTHER

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

CABGpreHAB multimodal prehabilitation intervention + usual care

Control (Standard treatment) OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned to have elective isolated first-time CABG surgery.
• years or older
• Two weeks or more before surgery
• Speaks and understands Danish.
• Gives written informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

The Department of Heart and Lung Surgery, Copenhagen University hospital Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Ida E Hoejskov, PhD

  Department of Heart Disease, Rigshospitalet, Copenhagen University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dorte Baek Olsen, PhD student

CONTACT

+4526625705; dorte.baek.olsen@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Nurse Specialist

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: June 24, 2025
• Study Start: June 24, 2025
• Primary Completion (Estimated): June 18, 2026
• Study Completion (Estimated): July 18, 2026
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)