Coronary Artery Disease Clinical Trial
— (PREP-ACE)Official title:
PREhabilitation in Patients Awaiting Acute Inpatient Cardiac SurgEry
NCT number | NCT06275100 |
Other study ID # | HUTH |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 3, 2024 |
Est. completion date | June 2025 |
Verified date | April 2024 |
Source | University of Hull |
Contact | Sarah Raut |
Phone | 01482624096 |
sarah.raut[@]nhs.net | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | June 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Hull University Teaching Hospital | Hull |
Lead Sponsor | Collaborator |
---|---|
University of Hull |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of prehabilitation in acute inpatients waiting for cardiac surgery | We will be assessing the eligibility, recruitment rate, deliverability, logistical, practicality, completion rate, achievability and acceptability of the program. This is based on the recruitment as well as participant feedback interview. | 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 | Efficacy of prehabilitation | To identify a signal of efficacy for positive changes in physical health exercise, mental wellbeing and quality of life. This is done by assessing participants changes in 6 minutes walk test (6MWT). | Assessment will be done on day 0 (recruitment), day 7 and day 14 or day before surgery | |
Secondary | Efficacy of prehabilitation | To identify a signal of efficacy for positive changes in physical health exercise, mental wellbeing and quality of life. This is done by assessing participants changes in hand grip strength. | Assessment will be done on day 0 (recruitment), day 7 and day 14 or day before surgery | |
Secondary | Efficacy of prehabilitation | To identify a signal of efficacy for positive changes in physical health exercise, mental wellbeing and quality of life. This is done by assessing participants changes in EuroQol questionnaire (EQ5D5L). | Assessment will be done on day 0 (recruitment), day 7 and day 14 or day before surgery | |
Secondary | Efficacy of prehabilitation | To identify a signal of efficacy for positive changes in physical health exercise, mental wellbeing and quality of life. This is done by assessing participants changes in Cardiac Anxiety Questionnaire (CAQ). | Assessment will be done on day 0 (recruitment), day 7 and day 14 or day before surgery | |
Secondary | Efficacy of prehabilitation | To identify a signal of efficacy for positive changes in physical health exercise, mental wellbeing and quality of life. This is done by assessing participants changes in spirometry. | Assessment will be done on day 0 (recruitment), day 7 and day 14 or day before surgery | |
Secondary | Complication rate | To identify differences in length of hospital stay, complications and readmission rates to hospital following surgery compared to usual care. This is done by comparing our outcomes with the hospital's standard care. Outcome from standard care will be obtained from hospital audit data | Day 0 (pre op) to day of patient discharge or 30 post op | |
Secondary | Safety of Prehabilitation in acute inpatients waiting for surgery | Throughout the study, we will be collecting information on adverse events, complications which may or may not be related to the intervention(s) | day 0 to day before surgery |
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