FRECycl-D

• Research type

  Research Study

• Full title

  Does in-bed Cycling delivered within 48 hours of mechanical ventilation, rEduce the occurrence of Delirium in critically ill patients (FRECycl-D): A mixed-methods Feasibility Randomised controlled trial.

• IRAS ID

  337629

• Contact name

  Jacqueline Bennion

• Contact email

  Jacqueline.Bennion@plymouth.ac.uk

• Sponsor organisation

  University Hospitals Plymouth NHS Trust

• Duration of Study in the UK

  1 years, 9 months, 31 days

• Research summary

  Background: Delirium is a state of severe confusion, where patients frequently see or hear things that are not real. This state can fluctuate daily leaving patients disorientated and distressed. It occurs in up to 4 out of 5 ICU patients who need support to breath (mechanical ventilation). Its effects often continue after hospital discharge, leading to a reduced quality of life, financial and social burdens on patients, families, and health services. The causes of delirium are unclear; but previous research has shown that delirium may be reduced if patients are active. However, no evidence exists to answer this question. In-bed cycling may be the solution to exercise in severely unwell patients. This study is designed to assess if in-bed cycling for patients receiving mechanical ventilation is possible and acceptable.

  Methods: This project has 3 parts:

  1. A small trial at two hospitals will randomly allocate 84-adult mechanically ventilated patients to receive either in-bed cycling for up to 14-days or until out of bed mobilisation begins (whichever comes first), in addition to usual NHS care or usual NHS care alone. This will test how well in-bed cycling is taken up and delivered and how high-quality data can be collected. Short and long-term patient-focused outcomes will be measured to help evaluate the study’s success.

  2. A sub-study at one of the hospitals will look at mechanisms that may cause delirium and whether in-bed cycling affects these mechanisms. This will involve measuring brain oxygenation and inflammation levels in the body. The information will help us understand more about exercise in the prevention of ICU-delirium.

  3. An interview study will gather the perspectives of trial participants (in the intervention arm), their family members and/or carers. This will help to evaluate the research including in-bed cycling and how this might be improved in the future.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  24/SC/0096

• Date of REC Opinion

  9 May 2024

• REC opinion

  Further Information Favourable Opinion