PREhabilitation in Patients Awaiting Acute Inpatient Cardiac SurgEry — (PREP-ACE)  

Coronary Artery Disease Clinical Trial

Official title: PREhabilitation in Patients Awaiting Acute Inpatient Cardiac SurgEry

Status Recruiting

Clinical Trial Summary

This is a single centre, single arm pilot feasibility study to determine the feasibility and practicality of prehabilitation in acute inpatients waiting for cardiac surgery. We will be looking into participant eligibility, acceptability, recruitment rates, completion rates and barriers to implementing a prehabilitation programme. Secondary outcomes include safety (incidence of adverse events directly related to the study), improvement in 6 minutes walk test (6MWT), hand grip strength, quality of life, and spirometry. At the end of the trial, we will be seeking the feedback of the participants to help us improve the design further.

Clinical Trial Description

Prehabilitation is a process of preparing a patient for major surgery with the aim of improving their outcome and recovery. Prehabilitation has shown benefits such as reduced post-operative complications and shorter inpatient stay in elective cardiac surgery population. There is currently no published research looking into the benefit of prehabilitation in acute inpatients.

I am currently doing an MD focusing on inpatients waiting for acute cardiac surgery in Castle Hill Hospital (CHH). The rationale for this is based on National Institute for Cardiovascular Outcomes Research (NICOR) report indicating that acute cardiac surgery waiting times increased, ranging from 7 to 24 days. Traditionally, inpatients are asked to have bed rest. However, this affects patient's mental and physical wellbeing, and hence negatively impact outcome.

The project consist of three parts. The first is an analysis of patients who had cardiac surgery in 2022 based on cardiac surgery audit data which is routinely collected for all patients. The purpose of this study is to assess the waiting times for acute cardiac surgery in East Yorkshire and describe the demographic and potential impact of the waiting times on these patients. We have sought local governance approval for this section as it involves data that is routinely collected in the department.

The second part of the project is a survey amongst patients waiting for acute cardiac surgery to gauge patient interest, how to engage them, opinion on design and potential problems that needs to be addressed.

The third and main part of the project is a single centre, single arm, prospective, pilot feasibility trial aiming to recruit 20 acute inpatients. The primary objective of the trial is to investigate the feasibility, acceptability and completion rates of prehabilitation. The secondary objective is to identify any potential improvement and safety concerns. The intervention involves exercise and anxiety management. The interventions will start as soon as the patient is recruited, end on the day before surgery and not impact the date of their surgery.

We have received ethical approval from Hull York Medical School (HYMS) ethics committee for the second and third part of the project. In addition to this, we have also applied for Research Ethics Committee (REC) approval in Integrated Research Application System (IRAS). We are awaiting the REC approval. ;

Related Conditions & MeSH terms

• Aortic Valve Disease
• Cardiac Disease
• Coronary Artery Disease
• Endocarditis
• Heart Diseases
• Heart Valve Diseases
• Valve Heart Disease

• NCT number: NCT06275100
• Study type: Interventional
• Source: University of Hull
• Contact: Sarah Raut
• Phone: 01482624096
• Email: sarah.raut@nhs.net
• Status: Recruiting
• Phase: N/A
• Start date: April 3, 2024
• Completion date: June 2025