- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03471247
CYCLE: A Randomized Clinical Trial of Early In-bed Cycling for Mechanically Ventilated Patients (CYCLE)
CYCLE RCT: An International, Multi-centre, Randomized Clinical Trial of Early In-bed Cycling for Mechanically Ventilated Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: Survivors of critical illness have a long road of physical, cognitive, and psychological recovery. Although medical advances have reduced the mortality of critical illness, survival often comes with substantial long-term morbidity and societal cost. At 1-year follow-up, ~35% of intensive care unit (ICU) survivors had sub-normal 6-minute walk distance, and ~50% had not returned to work. Rehabilitation interventions started in the ICU may reduce this morbidity. In-bed cycling is a novel technology that may help critically ill, mechanically ventilated (MV) patients receive exercise very early to prevent or attenuate muscle weakness. Patients on MV typically receive prolonged bedrest and are often perceived as 'too sick' for physiotherapy (PT) interventions. However expert consensus and our previous multicentre pilot work suggest these interventions are safe. The CYCLE RCT will evaluate whether early in-bed cycling compared to usual PT interventions improves patient-reported outcomes.
Objectives:
- CYCLE RCT: To determine if early in-bed cycling and routine PT compared to routine PT alone in critically ill, mechanically ventilated adults improves the primary outcome of physical function at 3 days after ICU discharge and secondary outcomes of strength, physical function, frailty, psychological distress, quality of life, mortality, and healthcare utilization.
- Economic Evaluation: To determine the cost-effectiveness of cycling and routine PT compared to routine PT alone among critically ill, mechanically ventilated adults.
Design: 360-patient concealed open-label RCT with blinded outcome assessment
Population: Critically ill adults receiving MV in a medical-surgical ICU
Methods: After informed consent, patients will be randomized to receive 30 minutes/day of cycling, 5 days per week and routine PT interventions or routine PT interventions alone. Assessors, blinded to treatment allocation, will measure the primary outcome of patients' physical function at 3 days post-ICU. Secondary outcomes will be measured at ICU awakening, ICU discharge, 3 days post-ICU, hospital discharge, and 90-days post-enrollment.
Relevance: By 2026, demand for ICU services is estimated to increase by 40% and more survivors will be at risk for post-ICU disability. If early cycling during critical illness improves short-term physical and functional outcomes, it could accelerate recovery and reduce long-term disability in ICU survivors.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michelle Kho, PT, PhD
- Phone Number: 28221 905-525-9140
- Email: khome@mcmaster.ca
Study Locations
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Victoria
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Heidelberg, Victoria, Australia, 3084
- Austin Health - Austin Hospital
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Ontario
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Brantford, Ontario, Canada, N3R 1G9
- Brant Community Healthcare System - Brantford General Hospital
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Hamilton, Ontario, Canada, L8N 4A6
- St. Joseph's Healthcare Hamilton
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Hamilton, Ontario, Canada, L8V 1C3
- Hamilton Health Sciences - Juravinski Hospital
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Hamilton, Ontario, Canada, L8L 2X2
- Hamilton Health Sciences - Hamilton General Hospital
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Kingston, Ontario, Canada, K7L 2V7
- Kingston Health Sciences Centre - Kingston General Hospital
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London, Ontario, Canada, N6A 5W9
- London Health Sciences Centre - Victoria Hospital
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Ottawa, Ontario, Canada, K1H 8L6
- The Ottawa Hospital - General Campus
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Ottawa, Ontario, Canada, K1Y 4E9
- The Ottawa Hospital - Civic Campus
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St. Catharines, Ontario, Canada, L2S 0A9
- Niagara Health System - St. Catharines Site
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Toronto, Ontario, Canada, M5B 1W8
- St. Michael's Hospital
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Quebec
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Lévis, Quebec, Canada, G6V 3Z1
- Centre intégré de santé et de services sociaux de Chaudière-Appalaches - Hôtel-Dieu de Lévis
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Montréal, Quebec, Canada, H4J 1C5
- Centre Integre Universitaire de Sante et de Services Sociaux du Nord-de-L'Ile-de-Montreal - Hopital du Sacre-Coeur de Montreal
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Sherbrooke, Quebec, Canada, J1H 5N4
- Centre Integre Universitaire de Sante et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke
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Maryland
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Baltimore, Maryland, United States, 21201
- University of Maryland Medical Centre
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient is ≥ 18 years of age
- Patient is invasively mechanically ventilated ≤ 4 days
- Expected additional 2 day ICU stay
- Ability to ambulate independently (with or without gait aid) before their critical illness
- ICU length of stay ≤ 7 days
Exclusion Criteria:
- Pre-hospital inability to follow simple commands in local language at baseline
- Acute conditions impairing ability to receive cycling
- Severe cognitive impairment pre-ICU
- Traumatic brain injury
- Acute proven or suspected central or peripheral neuromuscular weakness affecting the legs (e.g., stroke, Guillian-Barre syndrome, spinal injury)
- Temporary pacemaker (internal or external)
- Expected hospital mortality ≥ 90%
- Equipment unable to fit patient's body dimensions (elg., leg amputation, morbid obesity)
- Palliative goals of care
- Pregnancy (suspected or proven)
- Specific surgical exclusion as stipulated by surgery or ICU team
- Physician declines
- Cycling exemption not resolved during first 4 days of mechanical ventilation
- Patient already able to march on spot at time of screening
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: In-Bed Cycle Ergometer + Routine PT
Patients will receive 30 minutes of in-bed cycling once per day, 5 days per week, while they remain in the ICU, for up to a maximum of 28 days.
They will also receive routine physiotherapy.
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Physiotherapists will place the patient's legs in a specialized in-bed cycle ergometer allowing for gentle leg exercise.
Exercise can performed in passive, active-assisted, or active mode.
Other Names:
Includes, 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, ambulation, and assistance with optimizing airway clearance and respiratory function.
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Active Comparator: Routine PT
Patients will receive routine physiotherapy interventions per current institutional practice
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Includes, 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, ambulation, and assistance with optimizing airway clearance and respiratory function.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Function Test for ICU-scored (PFIT-s)
Time Frame: 3 days after ICU discharge
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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.
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3 days after ICU discharge
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Function Test for ICU-scored (PFIT-s)
Time Frame: ICU Awakening, approximately 6 days after ICU admission; ICU Discharge, approximately 12 days after ICU admission; 3 days after ICU discharge; Hospital Discharge, approximately 28 days after ICU admission
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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.
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ICU Awakening, approximately 6 days after ICU admission; ICU Discharge, approximately 12 days after ICU admission; 3 days after ICU discharge; Hospital Discharge, approximately 28 days after ICU admission
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Muscle Strength
Time Frame: ICU Awakening, approximately 6 days after ICU admission; ICU Discharge, approximately 12 days after ICU admission; 3 days after ICU discharge; Hospital Discharge, approximately 28 days after ICU admission
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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 scale (0 = no contraction, 5 = contraction sustained against maximal resistance).
Scores range from 0 to 60, with higher scores = better strength.
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ICU Awakening, approximately 6 days after ICU admission; ICU Discharge, approximately 12 days after ICU admission; 3 days after ICU discharge; Hospital Discharge, approximately 28 days after ICU admission
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30 Second Sit to Stand
Time Frame: ICU Awakening, approximately 6 days after ICU admission; ICU Discharge, approximately 12 days after ICU admission; 3 days after ICU discharge; Hospital Discharge, approximately 28 days after ICU admission
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Patient completes as many sit to stand repetitions as possible in 30 seconds.
Total number of repetitions is recorded as patient's score.
Higher repetitions represent better function.
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ICU Awakening, approximately 6 days after ICU admission; ICU Discharge, approximately 12 days after ICU admission; 3 days after ICU discharge; Hospital Discharge, approximately 28 days after ICU admission
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Two Minute Walk Test
Time Frame: ICU Discharge, approximately 12 days after ICU admission; 3 days after ICU discharge; Hospital Discharge, approximately 28 days after ICU admission
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Maximum distance walked in 2 minutes measured in metres on a continuous scale.
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ICU Discharge, approximately 12 days after ICU admission; 3 days after ICU discharge; Hospital Discharge, approximately 28 days after ICU admission
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Patient-Reported Functional Scale-ICU (PRFS-ICU)
Time Frame: ICU discharge, approximately 12 days after ICU admission; hospital discharge, approximately 28 days after ICU admission; 3 months after enrollment
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Assesses patient's perception of their physical function.
Patients rate their ability to perform 6 mobility activities on a 0-10 scale (0=unable to perform activity, 10=able to perform activity at same level as before ICU admission).
Scores range from 0 to 60, with higher scores representing better function.
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ICU discharge, approximately 12 days after ICU admission; hospital discharge, approximately 28 days after ICU admission; 3 months after enrollment
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Katz Activities of Daily Living (ADL) Scale
Time Frame: Baseline; ICU discharge, approximately 12 days after ICU admission; hospital discharge, approximately 28 days after ICU admission
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Rates 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.
Scores range from 0 to 6, with higher scores representing better function.
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Baseline; ICU discharge, approximately 12 days after ICU admission; hospital discharge, approximately 28 days after ICU admission
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Clinical Frailty Scale
Time Frame: Baseline; hospital discharge, approximately 28 days after ICU admission
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Patients are ranked on a scale from 1-9 according to level of frailty based on clinical descriptions (1 = very fit, 9 = terminally ill).
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Baseline; hospital discharge, approximately 28 days after ICU admission
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Intensive Care Psychological Assessment Tool (IPAT)
Time Frame: After ICU awakening assessment, approximately 7 days after ICU admission
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Patients answer 10 questions related to critical care-related psychological distress.
Scores range from 0-20, with scores of 7 or greater indicating a patient at risk of future psychological morbidity.
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After ICU awakening assessment, approximately 7 days after ICU admission
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Health-Related Quality of Life - EuroQol-5D-5L
Time Frame: ICU discharge, approximately 12 days after ICU admission; hospital discharge, approximately 28 days after ICU admission; 3 months after enrollment
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Five question self-administered, preference-based instrument to measure mobility, self-care, usual activities, pain, and anxiety/depression, as well as a visual analogue scale (VAS) global assessment of health.
For each dimension, the participant chooses 1 of 5 levels that best describes their health on that day: "no problem" (1), "slight" (2), "moderate" (3), "severe" (4), or "unable/extreme" (5).
The VAS is the participant's rating of their health on a scale of 0 "worst health you can imagine" to 100 "best health you can imagine".
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ICU discharge, approximately 12 days after ICU admission; hospital discharge, approximately 28 days after ICU admission; 3 months after enrollment
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Quality-Adjusted Life Years (QALYs)
Time Frame: 3 months after enrollment
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A measure of health outcomes for economic evaluation that incorporates the impact of an intervention on both the quantity and quality of life.
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3 months after enrollment
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Mortality
Time Frame: From study admission to 3 months after enrollment
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Death in ICU, hospital, or post-discharge.
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From study admission to 3 months after enrollment
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Hospital Discharge Location
Time Frame: Hospital discharge, approximately 28 days after ICU admission
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For survivors: home, inpatient rehabilitation, other hospital, chronic care, assisted living facility, nursing home.
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Hospital discharge, approximately 28 days after ICU admission
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Healthcare Utilization
Time Frame: From study admission to 3 months after enrollment
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Includes emergency room visits and hospitalizations, family doctor visits, specialist visits and outpatient clinics, other healthcare professional services.
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From study admission to 3 months after enrollment
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Intervention and Healthcare Costs
Time Frame: From study admission to 3 months after enrollment
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Includes emergency room visits and hospitalizations, family doctor visits, specialist visits and outpatient clinics, assistive devices, renovations and modifications, other healthcare professional services, employment status and time off work, assistance from others.
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From study admission to 3 months after enrollment
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Hospital Anxiety and Depression Scale (HADS)
Time Frame: 3 months after enrollment
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Patient answers 14 questions related to anxiety and depression.
Scores range from 0-21 with higher score indicating more distress.
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3 months after enrollment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michelle Kho, PT, PhD, McMaster University School of Rehabilitation Science
Publications and helpful links
General Publications
- Reid JC, Molloy A, Strong G, Kelly L, O'Grady H, Cook D, Archambault PM, Ball I, Berney S, Burns KEA, D'Aragon F, Duan E, English SW, Lamontagne F, Pastva AM, Rochwerg B, Seely AJE, Serri K, Tsang JLY, Verceles AC, Reeve B, Fox-Robichaud A, Muscedere J, Herridge M, Thabane L, Kho ME; CYCLE Investigators. Research interrupted: applying the CONSERVE 2021 Statement to a randomized trial of rehabilitation during critical illness affected by the COVID-19 pandemic. Trials. 2022 Sep 2;23(1):735. doi: 10.1186/s13063-022-06640-y.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CYCLE RCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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