CYCLE Pilot Randomized Trial

NCT02377830 | Completed Phase 2

• 1 other identifier: HIREB 14-531
• Study Type: interventional
• Target: 113
• Locations: 3 countries
• Sites: 9

Brief Summary

Background: Patients in the intensive care unit (ICU) are the sickest in hospital, and need advanced life-support. Survivors of critical illness are very weak and disabled. Up to 1 in 4 have severe leg weakness impairing their quality of life for as long as 5 years after ICU discharge. In-bed cycling involves use of special equipment that attaches to a patient's hospital bed, allowing them gentle exercise while in the ICU. Methods: Adult patients admitted to the ICU who need a breathing machine and are expected to survive their ICU stay are eligible. Patients will randomly receive 30 minutes of in-bed cycling each day they are in the ICU or routine physiotherapy, both delivered by specially trained physiotherapists. Outcomes: Feasibility: The investigators will study whether patients can cycle on most days of their ICU stay, whether patients and their families agree to be a part of the study, and whether investigators can systematically assess patients' strength. Relevance: Effective methods of physiotherapy are needed for critically ill patients to minimize muscle weakness, speed recovery, and improve quality of life. This pilot randomized study is the second of several future larger studies about in-bed cycling in the ICU. Our pilot work includes CYCLE Pilot and CYCLE Vanguard. CYCLE Pilot is an external pilot and enrolled 66 patients from 3/2015 to 6/2016. CYCLE Vanguard is an internal pilot and enrolled 47 patients from 11/2016 to 3/2018. CYCLE Vanguard patients will be analyzed in the main CYCLE RCT (NCT03471247).

Conditions

Intensive Care Unit Acquired Weakness; Critical Care; Mechanical Ventilation; Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• Patient accrual

  2 years

Secondary Outcomes (7)

• Cycling protocol violations (% cycling protocol violations)

  2 years

• Outcome measure ascertainment (% outcomes measured in hospital)

  2 years

• Blinded outcome measures at hospital discharge (% outcomes at hospital discharge measured by blinded outcome assessors)

  2 years

• Physical Function Test for ICU (PFIT) at ICU awakening, ICU discharge, 3-days post-ICU discharge (CYCLE Vanguard only) and hospital discharge

  From study admission to approximately 5, 12, 15 and 30 days, on average, respectively

• Muscle strength at ICU awakening, ICU discharge, 3-days post-ICU discharge (CYCLE Vanguard only), and hospital discharge

  From study admission to approximately 5, 12, 15 and 30 days, on average, respectively

Other Outcomes (2)

• Katz Activities of Daily Living Scale at ICU and hospital discharge

  From study admission to approximately 12 and 30 days, on average, respectively

• Euro-QOL 5DL

  From study admission to approximately 12 and 30 days, on average, respectively

Study Arms (2)

Early Cycling and routine physiotherapy

EXPERIMENTAL

Patients will receive 30 minutes of in-bed cycling in addition to routine physiotherapy, 5 days per week, for the duration of their ICU stay

Device: In-bed cycle ergometer (Restorative Therapies RT300 Supine)

Routine physiotherapy

ACTIVE COMPARATOR

Patients will receive routine physiotherapy per current institutional practice

Other: Routine physiotherapy

Interventions

In-bed cycle ergometer (Restorative Therapies RT300 Supine) DEVICE

Also known as: Restorative Therapies RT300 Supine

Early Cycling and routine physiotherapy

Routine physiotherapy OTHER

activities to assist with optimizing airway clearance and respiratory function, and, based on the patient's alertness and medical stability, activities to maintain or increase limb range of motion and strength, in- and out of bed mobility, and ambulation

Routine physiotherapy

Eligibility Criteria

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

You may qualify if:

• Adults admitted to a medical-surgical ICU within the 1st 4 days of mechanical ventilation (MV) and 1st 7 days of ICU, and
• could ambulate independently before hospital admission.

You may not qualify if:

• Acute condition impairing patients' ability to cycle (e.g., leg fracture),
• proven or suspected neuromuscular weakness affecting the legs (e.g., stroke or Guillain-Barré syndrome),
• unable to follow commands in English pre-ICU,
• temporary pacemaker,
• expected hospital mortality \>90%,
• unable to fit the bike, palliative goals of care, or persistent therapy exemptions in the 1st 4 days of MV (e.g., cardiorespiratory instability, active major bleeding)

Sponsors & Collaborators

• McMaster University: lead
• St. Joseph's Healthcare Hamilton: collaborator
• Hamilton Health Sciences Corporation: collaborator
• Technology Evaluation in the Elderly Network / Canadian Frailty Network: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• Ontario Lung Association: collaborator
• Canadian Respiratory Research Network: collaborator

Study Sites (9)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Austin Health

Melbourne, Victoria, 3084, Australia

Location

St. Joseph's Healthcare Intensive Care Unit

Hamilton, Ontario, L8N 4A6, Canada

Location

Hamilton Health Sciences General ICU

Hamilton, Ontario, Canada

Location

Hamilton Health Sciences Juravinski ICU

Hamilton, Ontario, Canada

Location

London Health Sciences

London, Ontario, Canada

Location

Ottawa General Hospital

Ottawa, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Toronto General Hospital

Toronto, Ontario, Canada

Location

Related Publications (9)

• Kho ME, Molloy AJ, Clarke FJ, Reid JC, Herridge MS, Karachi T, Rochwerg B, Fox-Robichaud AE, Seely AJ, Mathur S, Lo V, Burns KE, Ball IM, Pellizzari JR, Tarride JE, Rudkowski JC, Koo K, Heels-Ansdell D, Cook DJ. Multicentre pilot randomised clinical trial of early in-bed cycle ergometry with ventilated patients. BMJ Open Respir Res. 2019 Feb 18;6(1):e000383. doi: 10.1136/bmjresp-2018-000383. eCollection 2019.

  PMID: 30956804 RESULT

• Heels-Ansdell D, Kelly L, O'Grady HK, Farley C, Reid JC, Berney S, Pastva AM, Burns KE, D'Aragon F, Herridge MS, Seely A, Rudkowski J, Rochwerg B, Fox-Robichaud A, Ball I, Lamontagne F, Duan EH, Tsang J, Archambault PM, Verceles AC, Muscedere J, Mehta S, English SW, Karachi T, Serri K, Reeve B, Thabane L, Cook D, Kho ME. Early In-Bed Cycle Ergometry With Critically Ill, Mechanically Ventilated Patients: Statistical Analysis Plan for CYCLE (Critical Care Cycling to Improve Lower Extremity Strength), an International, Multicenter, Randomized Clinical Trial. JMIR Res Protoc. 2024 Oct 28;13:e54451. doi: 10.2196/54451.

  PMID: 39467285 DERIVED

• O'Grady HK, Ball I, Berney S, Burns KEA, Cook DJ, Fox-Robichaud A, Herridge MS, Karachi T, Mathur S, Reid JC, Rochwerg B, Rollinson T, Rudkowski JC, Bosch J, Turkstra LS, Kho ME. Characterizing usual-care physical rehabilitation in Canadian intensive care unit patients: a secondary analysis of the Canadian multicentre Critical Care Cycling to Improve Lower Extremity Strength pilot randomized controlled trial. Can J Anaesth. 2024 Oct;71(10):1406-1416. doi: 10.1007/s12630-024-02838-7. Epub 2024 Sep 24.

  PMID: 39317833 DERIVED

• Kho ME, Berney S, Pastva AM, Kelly L, Reid JC, Burns KEA, Seely AJ, D'Aragon F, Rochwerg B, Ball I, Fox-Robichaud AE, Karachi T, Lamontagne F, Archambault PM, Tsang JL, Duan EH, Muscedere J, Verceles AC, Serri K, English SW, Reeve BK, Mehta S, Rudkowski JC, Heels-Ansdell D, O'Grady HK, Strong G, Obrovac K, Ajami D, Camposilvan L, Tarride JE, Thabane L, Herridge MS, Cook DJ. Early In-Bed Cycle Ergometry in Mechanically Ventilated Patients. NEJM Evid. 2024 Jul;3(7):EVIDoa2400137. doi: 10.1056/EVIDoa2400137. Epub 2024 Jun 12.

  PMID: 38865147 DERIVED

• Kho ME, Reid J, Molloy AJ, Herridge MS, Seely AJ, Rudkowski JC, Buckingham L, Heels-Ansdell D, Karachi T, Fox-Robichaud A, Ball IM, Burns KEA, Pellizzari JR, Farley C, Berney S, Pastva AM, Rochwerg B, D'Aragon F, Lamontagne F, Duan EH, Tsang JLY, Archambault P, English SW, Muscedere J, Serri K, Tarride JE, Mehta S, Verceles AC, Reeve B, O'Grady H, Kelly L, Strong G, Hurd AH, Thabane L, Cook DJ; CYCLE Investigators and the Canadian Critical Care Trials Group. Critical Care Cycling to Improve Lower Extremity Strength (CYCLE): protocol for an international, multicentre randomised clinical trial of early in-bed cycling for mechanically ventilated patients. BMJ Open. 2023 Jun 23;13(6):e075685. doi: 10.1136/bmjopen-2023-075685.

  PMID: 37355270 DERIVED

• Takaoka A, Heels-Ansdell D, Cook DJ, Kho ME. The Association between Frailty and Short-Term Outcomes in an Intensive Care Unit Rehabilitation Trial: An Exploratory Analysis. J Frailty Aging. 2021;10(1):49-55. doi: 10.14283/jfa.2020.52.

  PMID: 33331622 DERIVED

• Reid JC, McCaskell DS, Kho ME. Therapist perceptions of a rehabilitation research study in the intensive care unit: a trinational survey assessing barriers and facilitators to implementing the CYCLE pilot randomized clinical trial. Pilot Feasibility Stud. 2019 Nov 12;5:131. doi: 10.1186/s40814-019-0509-3. eCollection 2019.

  PMID: 31741746 DERIVED

• McCaskell DS, Molloy AJ, Childerhose L, Costigan FA, Reid JC, McCaughan M, Clarke F, Cook DJ, Rudkowski JC, Farley C, Karachi T, Rochwerg B, Newman A, Fox-Robichaud A, Herridge MS, Lo V, Feltracco D, Burns KE, Porteous R, Seely AJE, Ball IM, Seczek A, Kho ME. Project management lessons learned from the multicentre CYCLE pilot randomized controlled trial. Trials. 2019 Aug 28;20(1):532. doi: 10.1186/s13063-019-3634-7.

  PMID: 31455384 DERIVED

• Kho ME, Molloy AJ, Clarke F, Herridge MS, Koo KK, Rudkowski J, Seely AJ, Pellizzari JR, Tarride JE, Mourtzakis M, Karachi T, Cook DJ; Canadian Critical Care Trials Group. CYCLE pilot: a protocol for a pilot randomised study of early cycle ergometry versus routine physiotherapy in mechanically ventilated patients. BMJ Open. 2016 Apr 8;6(4):e011659. doi: 10.1136/bmjopen-2016-011659.

  PMID: 27059469 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Michelle Kho, PT, PhD

  McMaster University School of Rehabilitation Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: March 4, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 5, 2022

Record last verified: 2022-11

Locations

AU (1); CA (7); US (1)