Clinical trial NCT06275100: PREhabilitation in Patients Awaiting Acute Inpatient Cardiac SurgEry
Official title: PREhabilitation in Patients Awaiting Acute Inpatient Cardiac SurgEry
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiac Disease
Aortic Valve Disease
Coronary Artery Disease
Endocarditis
Valve Heart Disease
Lead sponsor: University of Hull
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm pilot feasibility study in acute inpatients waiting for cardiac surgery. Intervention is a prehabilitation program
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* All patients over the age of 18 scheduled for acute cardiac surgery in CHH will be given consideration to participate in this clinical trial.

Exclusion Criteria:

* Patients who are unable or unwilling to participate in any of the elements of prehabilitation will be excluded. These include those that have cognitive disability (including unconsciousness), cardiac or clinical instability, functional or anatomical impairment which impairs ability to participate, language barrier or patient refusal. Patients that have impending surgery within 72 hours of arrival to hospital will be excluded. Patients who are awaiting surgery in district hospitals or outside of Castle Hill Hospital will be excluded. A non-exhaustive list of exclusion criteria is included below.

Cardiac/ clinical instability such as:

* Recurrent unstable angina/ crescendo angina
* Untreated decompensated heart failure
* Malignant arrhythmias awaiting treatment
* Resting tachycardia (HR\>100 bpm)
* Left ventricular outflow obstruction such as Aortic Stenosis with pre-syncopal or syncopal symptoms
* Unresolved acute pericarditis or myocarditis
* Second or third degree heart block without pacemaker
* Aortic Dissection
* Myxoma

Functional/ anatomical impairment such as:

* Severe musculoskeletal conditions that would prohibit exercise
* Amputees
* Registered blind

Primary outcomes:
measure: Feasibility of prehabilitation in acute inpatients waiting for cardiac surgery
timeFrame: We estimate from patient recruitment to day before surgery can be between 7 days and 4 weeks. Intervention will start as soon as patient is recruited and end the day before their surgery
Secondary outcomes:
measure: Efficacy of prehabilitation
timeFrame: Assessment will be done on day 0 (recruitment), day 7 and day 14 or day before surgery
measure: Efficacy of prehabilitation
timeFrame: Assessment will be done on day 0 (recruitment), day 7 and day 14 or day before surgery
measure: Efficacy of prehabilitation
timeFrame: Assessment will be done on day 0 (recruitment), day 7 and day 14 or day before surgery
measure: Efficacy of prehabilitation
timeFrame: Assessment will be done on day 0 (recruitment), day 7 and day 14 or day before surgery
measure: Efficacy of prehabilitation
timeFrame: Assessment will be done on day 0 (recruitment), day 7 and day 14 or day before surgery
measure: Complication rate
timeFrame: Day 0 (pre op) to day of patient discharge or 30 post op
measure: Safety of Prehabilitation in acute inpatients waiting for surgery
timeFrame: day 0 to day before surgery
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Hull University Teaching Hospital
Study officials:
affiliation: University of Hull
name: Sarah Raut
role: PRINCIPAL_INVESTIGATOR
References: