CYCLE Pilot Randomized Trial (CYCLE Pilot)

CYCLE Pilot: A Pilot Randomized Study of Early Cycle Ergometry Versus Routine Physiotherapy in Mechanically Ventilated Patients

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).

Study Overview

• Status: Completed
• Conditions: Respiratory Failure; Critical Care; Mechanical Ventilation; Intensive Care Unit Acquired Weakness
• Intervention / Treatment: Device: In-bed cycle ergometer (Restorative Therapies RT300 Supine); Other: Routine physiotherapy

• Study Type: Interventional
• Enrollment (Actual): 113
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3084
      • Austin Health
• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • St. Joseph's Healthcare Intensive Care Unit
    • Hamilton, Ontario, Canada
      • Hamilton Health Sciences General ICU
    • Hamilton, Ontario, Canada
      • Hamilton Health Sciences Juravinski ICU
    • London, Ontario, Canada
      • London Health Sciences
    • Ottawa, Ontario, Canada
      • Ottawa General Hospital
    • Toronto, Ontario, Canada
      • St. Michael's Hospital
    • Toronto, Ontario, Canada
      • Toronto General Hospital
• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early Cycling and routine physiotherapy; 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); Other Names: Restorative Therapies RT300 Supine
Active Comparator: Routine physiotherapy; Patients will receive routine physiotherapy per current institutional practice	Other: Routine physiotherapy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient accrual	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cycling protocol violations (% cycling protocol violations)	% cycling protocol violations	2 years
Outcome measure ascertainment (% outcomes measured in hospital)	% outcomes measured in hospital	2 years
Blinded outcome measures at hospital discharge (% outcomes at hospital discharge measured by blinded outcome assessors)	% 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	Patients complete 4 activities: arm and leg strength, ability to stand, and step cadence. Scores range from 0 to 10, with higher scores = better function	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	Manual muscle testing using the Medical Research Council (MRC) Scale. The patient exerts a force against the examiner's resistance. Each muscle is assessed on a 6-point MRC scale (0=no contraction; 5=contraction sustained against maximal resistance).	From study admission to approximately 5, 12, 15 and 30 days, on average, respectively
Quadriceps strength at ICU and hospital discharge (Force measured in Kg and in Newtons on a continuous scale)	The patient exerts a force against a small strain gauge that fits in the examiner's hand. .	From study admission to approximately 12 and 30 days, on average, respectively
2 minute walk test at ICU discharge, 3-days post-ICU (CYCLE Vanguard only), and hospital discharge	Maximum distance walked in 2 minutes measured in metres on a continuous scale	From study admission to approximately 12 and 30 days, on average, respectively

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Katz Activities of Daily Living Scale at ICU and hospital discharge	The patient's ability to complete 6 tasks: bathing, dressing, toileting, feeding, continence, and bed mobility. A rater assesses whether the patient is dependent or independent according to pre-specified criteria.	From study admission to approximately 12 and 30 days, on average, respectively
Euro-QOL 5DL	5 question self-administered, preference-based instrument to measure mobility, self-care, usual activities, pain, and anxiety/ depression, as well as a global assessment of health	From study admission to approximately 12 and 30 days, on average, respectively

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: St. Joseph's Healthcare Hamilton; Canadian Institutes of Health Research (CIHR); Hamilton Health Sciences Corporation; Ontario Lung Association; Technology Evaluation in the Elderly Network / Canadian Frailty Network; Canadian Respiratory Research Network
• Investigators: Principal Investigator: Michelle Kho, PT, PhD, McMaster University School of Rehabilitation Science

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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. Erratum In: Trials. 2019 Oct 25;20(1):606.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: February 26, 2015
• First Submitted That Met QC Criteria: March 3, 2015
• First Posted (Estimate): March 4, 2015

Study Record Updates

• Last Update Posted (Actual): December 5, 2022
• Last Update Submitted That Met QC Criteria: November 30, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: HIREB 14-531