PREhabilitation in Patients Awaiting Acute Inpatient Cardiac SurgEry

NCT06275100 | Recruiting DMC

• 1 other identifier: HUTH
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Disease; Aortic Valve Disease; Coronary Artery Disease; Endocarditis; Valve Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Efficacy of prehabilitation

  Assessment will be done on day 0 (recruitment), day 7 and day 14 or day before surgery

• Efficacy of prehabilitation

  Assessment will be done on day 0 (recruitment), day 7 and day 14 or day before surgery

• Efficacy of prehabilitation

  Assessment will be done on day 0 (recruitment), day 7 and day 14 or day before surgery

• Efficacy of prehabilitation

  Assessment will be done on day 0 (recruitment), day 7 and day 14 or day before surgery

• Efficacy of prehabilitation

  Assessment will be done on day 0 (recruitment), day 7 and day 14 or day before surgery

Study Arms (1)

Prehabilitation arm

EXPERIMENTAL

Participants will be exposed to physical and psychological prehabilitation whilst waiting for surgery. The prehabilitation will not alter the surgical waiting time or any medical intervention but aims to work around patient's essential care. Physical/ exercise component has a directly supervised component (aerobic exercise) and an unsupervised portion (Inspiratory muscle training and strength training) which is done via an app or leaflet depending on participant's preference. Participants will be given a guide number of exercises to do in their own time throughout the day. The psychological component consist of a psychoeducation booklet, meditation audio and signposting if they require further assistance. The psychoeducation component is voluntary.

Other: Prehabilitation

Interventions

Prehabilitation OTHER

Participants will be exposed to exercise and psychoeducation. Aerobic exercise will be on a cycle ergometer tailored to their capability and will aim for a low to moderate intensity.The patients will be exercised using the intermittent protocol of alternating 1 minute moderate and 1 minute low intensity aerobic exercise. This duration can be gradually increased during subsequent sessions depending on the patient's ability. Aerobic exercise will be conducted 2- 3 times per week depending on patient's ability. In addition, participants are expected to do strength and inspiratory muscle training in their own time. The psychoeducation booklet and audio are designed with input from in-house clinical psychologist. The aim of the booklet is to explain the emotions they may feel whilst being in hospital, symptoms of anxiety, suggest how to manage anxiety, behavioural strategies that may help and signposting if they require further support.

Also known as: exercise, psychological

Prehabilitation arm

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Hull: lead

Study Sites (1)

Hull University Teaching Hospital

Hull, HU1 3DR, United Kingdom

RECRUITING

Related Publications (1)

• Raut S, Hales A, Twiddy M, Dixon L, Ngaage D, Yates D, Danjoux G, Ingle L. Multimodal prehabilitation in people awaiting acute inpatient cardiac surgery: Study protocol for a pilot feasibility trial (PreP-ACe). PLoS One. 2025 Mar 10;20(3):e0307341. doi: 10.1371/journal.pone.0307341. eCollection 2025.

  PMID: 40063583 DERIVED

MeSH Terms

Conditions

Heart Diseases; Aortic Valve Disease; Coronary Artery Disease; Endocarditis; Heart Valve Diseases

Interventions

Preoperative Exercise; Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Sarah Raut

  University of Hull

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Raut

CONTACT

01482624096; sarah.raut@nhs.net

Lee Ingle

CONTACT

01482463141; l.ingle@hull.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm pilot feasibility study in acute inpatients waiting for cardiac surgery. Intervention is a prehabilitation program

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: February 23, 2024
• Study Start: April 3, 2024
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)