An interventional study of In-Bed Cycle Ergometer and Routine PT in Intensive Care Unit Acquired Weakness, Critical Care and Mechanical Ventilation, sponsored by McMaster University. Completed at 16 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by McMaster University · Not applicable, Interventional, and Treatment
Patients who survive critical illness usually experience long-lasting physical and psychological impairments, which are often debilitating. Rehabilitation interventions started in the ICU may reduce this morbidity. In-bed cycling, which uses a special bicycle that attaches to the hospital bed, allows critically ill patients who are mechanically ventilated (MV) to gently exercise their legs while in the ICU. The main goal of this study is to determine whether critically ill MV adults recover faster if they receive early in-bed cycling than if they do not. Another objective is to determine whether in-bed cycling is a cost-effective intervention. 360 patients admitted to the ICU and receiving MV will be enrolled in the study. Following informed consent, patients will be randomized to either (1) early in-bed cycling and routine physiotherapy or (2) routine physiotherapy alone. Patients' strength and physical function will be measured throughout the study. If early in-bed cycling during critical illness improves short-term physical and functional outcomes, it could accelerate recovery and reduce long-term disability in ICU survivors.
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:
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.
1,675 studies on the registry are indexed under Respiratory Insufficiency; 300 are open to participants now.
This study's enrollment of 363 is above the median of 55 across 1,056 interventional studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →McMaster University is the lead sponsor of 738 studies on the registry; 125 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
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Exclusion Criteria:
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.
Device: In-Bed Cycle Ergometer · Other: Routine PT
Patients will receive routine physiotherapy interventions per current institutional practice
Other: Routine PT
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.
Also known as: Restorative Therapies RT300 Supine
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.
Physical Function Test for ICU-scored (PFIT-s)
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.
Time frame: 3 days after ICU discharge
Physical Function Test for ICU-scored (PFIT-s)
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.
Time frame: ICU Awakening, approximately 6 days after ICU admission; ICU Discharge, approximately 12 days after ICU admission; Hospital Discharge, approximately 28 days after ICU admission
Muscle Strength
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.
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
30 Second Sit to Stand
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.
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
Two Minute Walk Test
Maximum distance walked in 2 minutes measured in metres on a continuous scale.
Time frame: ICU Discharge, approximately 12 days after ICU admission; 3 days after ICU discharge; Hospital Discharge, approximately 28 days after ICU admission
Patient-Reported Functional Scale-ICU (PRFS-ICU)
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.
Time frame: ICU discharge, approximately 12 days after ICU admission; hospital discharge, approximately 28 days after ICU admission; 3 months after enrollment
Katz Activities of Daily Living (ADL) Scale
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.
Time frame: Baseline; ICU discharge, approximately 12 days after ICU admission; hospital discharge, approximately 28 days after ICU admission
Clinical Frailty Scale
Patients are ranked on a scale from 1-9 according to level of frailty based on clinical descriptions (1 = very fit, 9 = terminally ill).
Time frame: Baseline; hospital discharge, approximately 28 days after ICU admission
Intensive Care Psychological Assessment Tool (IPAT)
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.
Time frame: After ICU awakening assessment, approximately 7 days after ICU admission
Duration of Mechanical Ventilation
Duration of invasive mechanical ventilation
Time frame: From study admission to ICU discharge, approximately 10 days
Length of stay
ICU and Hospital length of stay
Time frame: From hospital admission to ICU discharge (approximately 14 days) and hospital discharge (approximately 21 days)
Health-Related Quality of Life - EuroQol-5D-5L and Visual Analogue Scale
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".
Time frame: ICU discharge, approximately 12 days after ICU admission; hospital discharge, approximately 28 days after ICU admission; 3 months after enrollment
Mortality
Death in ICU, hospital, or post-discharge.
Time frame: From study admission to 3 months after enrollment
Hospital Discharge Location
For survivors: home, inpatient rehabilitation, other hospital, chronic care, assisted living facility, nursing home.
Time frame: Hospital discharge, approximately 28 days after ICU admission
Hospital Anxiety and Depression Scale (HADS)
Patient answers 14 questions related to anxiety and depression. Scores range from 0-21 with higher score indicating more distress.
Time frame: 3 months after enrollment
Quality-Adjusted Life Years (QALYs)
A measure of health outcomes for economic evaluation that incorporates the impact of an intervention on both the quantity and quality of life.
Time frame: 3 months after enrollment
Healthcare Utilization
Includes emergency room visits and hospitalizations, family doctor visits, specialist visits and outpatient clinics, other healthcare professional services.
Time frame: From study admission to 3 months after enrollment
Intervention and Healthcare Costs
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.
Time frame: From study admission to 3 months after enrollment
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Plan to share: No
Ran from Oct 2018 to primary completion in May 2023, 55 months.
Of 421 non-industry interventional studies with no phase under Respiratory Insufficiency, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 55 months is above that.
Counting every sponsor, half of 439 studies reached it within 23 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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