CABGpreHAB - a Feasibility Study Protocol

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Planned to have elective isolated first-time CABG surgery.

18 years or older

Two weeks or more before surgery

Speaks and understands Danish.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multimodal prehabilitation intervention

    Other 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

  • Control (Standard treatment)

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: CABGpreHAB multimodal prehabilitation intervention + usual careExperimental treatment 1 intervention
Group B: Control groupOther 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility outcome: recruitement rate

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

Time frame
Through study completition, an average of 1 year
2

Feasibility outcome: Attrition rates

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

Time frame
Up to 30 days post surgery index
3

Feasibility outcome: Fidelity

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

Time frame
preoperative
4

Feasibility outcome: Adherence rates

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

Time frame
Preoperative

Secondary outcomes

1

Exercise capacity

6MWT measures total walking distance in meters completed in six minutes

Time frame
Three times: at baseline, preoperative and 30 days post surgery index
2

Muscle strength

30 seconds sit-to-stand measured by numbers of sit-to-stands in 30 seconds

Time frame
Three times: at baseline, preoperative and 30 days post surgery index
3

Muscle strength handgrip

Measured in kilograms using a hand-held dynamometer

Time frame
At baseline and preoperative
4

Bodycomposition

Using a Bioelectrical Impedance Analyzer (BIA), body composition estimation: fat mass in kilograms, Fat mass as a percentage of weight, Fat-free mass in kilograms, Fat-free mass as a percentage of weight

Time frame
At baseline and preoperative

Other outcomes

1

Complications postoperatively

Rates of pneumonia, atelectasis, hemorrhage, cardiac arrhythmias, and delirium will be measured postoperatively

Time frame
From date of surgery and up to 30 days postopetively.
2

ICU-LOS

ICU-LOS will be calculated in hours

Time frame
From date and time of surgery until the date and time of discharge to the ward.
3

LOS

LOS will be calculated in days

Time frame
From date of surgery until date of discharge from the ward
4

DAOH30

DAOH30 will be calculated in days

Time frame
From date of surgery and up to 30 days postopetively.

Sponsors and contacts

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