Critical Care Cycling Study (CYCLIST) trial protocol: a randomised controlled trial of usual care plus additional in-bed cycling sessions versus usual care in the critically ill
- PMID: 29061618
- PMCID: PMC5665265
- DOI: 10.1136/bmjopen-2017-017393
Critical Care Cycling Study (CYCLIST) trial protocol: a randomised controlled trial of usual care plus additional in-bed cycling sessions versus usual care in the critically ill
Abstract
Introduction: In-bed cycling with patients with critical illness has been shown to be safe and feasible, and improves physical function outcomes at hospital discharge. The effects of early in-bed cycling on reducing the rate of skeletal muscle atrophy, and associations with physical and cognitive function are unknown.
Methods and analysis: A single-centre randomised controlled trial in a mixed medical-surgical intensive care unit (ICU) will be conducted. Adult patients (n=68) who are expected to be mechanically ventilated for more than 48 hours and remain in ICU for a further 48 hours from recruitment will be randomly allocated into either (1) a usual care group or (2) a group that receives usual care and additional in-bed cycling sessions. The primary outcome is change in rectus femoris cross-sectional area at day 10 in comparison to baseline measured by blinded assessors. Secondary outcome measures include muscle strength, incidence of ICU-acquired weakness, handgrip strength, time to achieve functional milestones (sitting out of bed, walking), Functional Status Score in ICU, ICU Mobility Scale, 6 min walk test 1 week post-ICU discharge, incidence of delirium and quality of life (EuroQol Five Dimensions questionnaire Five Levels scale). Quality of life assessments will be conducted post-ICU admission at day 10, 3 and 6 months after acute hospital discharge. Participants in the intervention group will complete an acceptability of intervention questionnaire.
Ethics and dissemination: Appropriate ethical approval from Metro South Health Human Research Ethics Committee has been attained. Results will be published in peer-reviewed publications and presented at scientific conferences to assist planning of future multicentre randomised controlled trials (if indicated) that will test in-bed cycling as an intervention to improve the physical, cognitive and health-related quality of life outcomes of patients with critical illness.
Trial registration number: This trial has been prospectively registered on the Australian and New Zealand Clinical Trial Registry (ACTRN12616000948493); Pre-results.
Keywords: critical illness; cycle ergometry; muscle atrophy; physiotherapy; rehabilitation medicine.
© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
Conflict of interest statement
Competing interests: None declared.
Figures
Similar articles
-
Nutrition and Exercise in Critical Illness Trial (NEXIS Trial): a protocol of a multicentred, randomised controlled trial of combined cycle ergometry and amino acid supplementation commenced early during critical illness.BMJ Open. 2019 Jul 31;9(7):e027893. doi: 10.1136/bmjopen-2018-027893. BMJ Open. 2019. PMID: 31371287 Free PMC article.
-
Fitness and mobility training in patients with Intensive Care Unit-acquired muscle weakness (FITonICU): study protocol for a randomised controlled trial.Trials. 2016 Nov 24;17(1):559. doi: 10.1186/s13063-016-1687-4. Trials. 2016. PMID: 27881152 Free PMC article. Clinical Trial.
-
Therapeutic respiratory and functional rehabilitation protocol for intensive care unit patients affected by COVID-19: a structured summary of a study protocol for a randomised controlled trial.Trials. 2021 Apr 12;22(1):268. doi: 10.1186/s13063-021-05210-y. Trials. 2021. PMID: 33845878 Free PMC article.
-
Early intervention (mobilization or active exercise) for critically ill adults in the intensive care unit.Cochrane Database Syst Rev. 2018 Mar 27;3(3):CD010754. doi: 10.1002/14651858.CD010754.pub2. Cochrane Database Syst Rev. 2018. PMID: 29582429 Free PMC article. Review.
-
Exercise rehabilitation following intensive care unit discharge for recovery from critical illness.Cochrane Database Syst Rev. 2015 Jun 22;2015(6):CD008632. doi: 10.1002/14651858.CD008632.pub2. Cochrane Database Syst Rev. 2015. PMID: 26098746 Free PMC article. Review.
Cited by
-
Assessing the safety of physical rehabilitation in critically ill patients: a Delphi study.Crit Care. 2024 Apr 30;28(1):144. doi: 10.1186/s13054-024-04919-x. Crit Care. 2024. PMID: 38689372 Free PMC article.
-
Cutting-Edge Physical Therapy in Mechanical Circulatory Support: Critical Care Physical Therapy Perspectives.Tex Heart Inst J. 2023 Jul 17;50(4):e238180. doi: 10.14503/THIJ-23-8180. Tex Heart Inst J. 2023. PMID: 37470248 Free PMC article. No abstract available.
-
Early Mobilization for Critically Ill Patients.Respir Care. 2023 Jun;68(6):781-795. doi: 10.4187/respcare.10481. Epub 2023 Apr 11. Respir Care. 2023. PMID: 37041029 Free PMC article. Review.
-
Clinical effects of neuroendoscopic hematoma evacuation for hypertensive intracerebral hemorrhage.Am J Transl Res. 2022 Feb 15;14(2):1084-1091. eCollection 2022. Am J Transl Res. 2022. PMID: 35273711 Free PMC article.
-
The effect of self-management on the knowledge, beliefs, behavior and subjective well-being in stroke patients during the rehabilitation phase.Am J Transl Res. 2021 Jul 15;13(7):8337-8343. eCollection 2021. Am J Transl Res. 2021. PMID: 34377325 Free PMC article.
References
-
- Gosselink R, Bott J, Johnson M, et al. . Physiotherapy for adult patients with critical illness: recommendations of the European Respiratory Society and European Society of Intensive Care Medicine Task Force on Physiotherapy for Critically Ill Patients. Intensive Care Med 2008;34:1188–99. 10.1007/s00134-008-1026-7 - DOI - PubMed
-
- Berney SC, Harrold M, Webb SA, et al. . Intensive care unit mobility practices in Australia and New Zealand: a point prevalence study. Crit Care Resusc 2013;15:260–5. - PubMed
Publication types
MeSH terms
LinkOut - more resources
Full Text Sources
Other Literature Sources
Medical