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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03471247
Registration number
NCT03471247
Ethics application status
Date submitted
7/03/2018
Date registered
20/03/2018
Date last updated
3/05/2024
Titles & IDs
Public title
CYCLE: A Randomized Clinical Trial of Early In-bed Cycling for Mechanically Ventilated Patients
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Scientific title
CYCLE RCT: An International, Multi-centre, Randomized Clinical Trial of Early In-bed Cycling for Mechanically Ventilated Patients
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Secondary ID [1]
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CYCLE RCT
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Universal Trial Number (UTN)
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Trial acronym
CYCLE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Intensive Care Unit Acquired Weakness
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Critical Care
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Mechanical Ventilation
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Respiratory Failure
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - In-Bed Cycle Ergometer
Other interventions - Routine PT
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.
Active Comparator: Routine PT - Patients will receive routine physiotherapy interventions per current institutional practice
Treatment: Devices: In-Bed Cycle Ergometer
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 interventions: Routine PT
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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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Physical Function Test for ICU-scored (PFIT-s)
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Assessment method [1]
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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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Timepoint [1]
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3 days after ICU discharge
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Secondary outcome [1]
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Physical Function Test for ICU-scored (PFIT-s)
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Assessment method [1]
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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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Timepoint [1]
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ICU Awakening, approximately 6 days after ICU admission; ICU Discharge, approximately 12 days after ICU admission; Hospital Discharge, approximately 28 days after ICU admission
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Secondary outcome [2]
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Muscle Strength
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Assessment method [2]
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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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Timepoint [2]
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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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Secondary outcome [3]
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30 Second Sit to Stand
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Assessment method [3]
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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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Timepoint [3]
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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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Secondary outcome [4]
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Two Minute Walk Test
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Assessment method [4]
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Maximum distance walked in 2 minutes measured in metres on a continuous scale.
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Timepoint [4]
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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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Secondary outcome [5]
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Patient-Reported Functional Scale-ICU (PRFS-ICU)
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Assessment method [5]
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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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Timepoint [5]
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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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Secondary outcome [6]
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Katz Activities of Daily Living (ADL) Scale
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Assessment method [6]
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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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Timepoint [6]
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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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Secondary outcome [7]
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Clinical Frailty Scale
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Assessment method [7]
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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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Timepoint [7]
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Baseline; hospital discharge, approximately 28 days after ICU admission
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Secondary outcome [8]
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Intensive Care Psychological Assessment Tool (IPAT)
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Assessment method [8]
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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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Timepoint [8]
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After ICU awakening assessment, approximately 7 days after ICU admission
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Secondary outcome [9]
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Duration of Mechanical Ventilation
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Assessment method [9]
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Duration of invasive mechanical ventilation
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Timepoint [9]
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From study admission to ICU discharge, approximately 10 days
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Secondary outcome [10]
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Length of stay
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Assessment method [10]
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ICU and Hospital length of stay
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Timepoint [10]
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From hospital admission to ICU discharge (approximately 14 days) and hospital discharge (approximately 21 days)
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Secondary outcome [11]
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Health-Related Quality of Life - EuroQol-5D-5L and Visual Analogue Scale
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Assessment method [11]
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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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Timepoint [11]
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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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Secondary outcome [12]
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Mortality
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Assessment method [12]
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Death in ICU, hospital, or post-discharge.
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Timepoint [12]
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From study admission to 3 months after enrollment
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Secondary outcome [13]
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Hospital Discharge Location
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Assessment method [13]
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For survivors: home, inpatient rehabilitation, other hospital, chronic care, assisted living facility, nursing home.
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Timepoint [13]
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Hospital discharge, approximately 28 days after ICU admission
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Secondary outcome [14]
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Hospital Anxiety and Depression Scale (HADS)
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Assessment method [14]
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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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Timepoint [14]
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3 months after enrollment
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Secondary outcome [15]
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Quality-Adjusted Life Years (QALYs)
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Assessment method [15]
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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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Timepoint [15]
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3 months after enrollment
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Secondary outcome [16]
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Healthcare Utilization
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Assessment method [16]
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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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Timepoint [16]
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From study admission to 3 months after enrollment
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Secondary outcome [17]
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Intervention and Healthcare Costs
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Assessment method [17]
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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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Timepoint [17]
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From study admission to 3 months after enrollment
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
15/10/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2024
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Actual
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Sample size
Target
360
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Austin Health - Austin Hospital - Heidelberg
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Recruitment postcode(s) [1]
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3084 - Heidelberg
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Maryland
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Country [2]
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United States of America
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State/province [2]
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North Carolina
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Country [3]
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Canada
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State/province [3]
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Ontario
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Country [4]
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Canada
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State/province [4]
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Quebec
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Funding & Sponsors
Primary sponsor type
Other
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Name
McMaster University
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Address
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Other collaborator category [1]
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Other
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Name [1]
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St. Joseph's Healthcare Hamilton
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Canadian Institutes of Health Research (CIHR)
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Address [2]
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Other collaborator category [3]
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Other
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Name [3]
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Canadian Critical Care Trials Group
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03471247
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Trial related presentations / 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.
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Public notes
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Contacts
Principal investigator
Name
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Michelle Kho, PT, PhD
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Address
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McMaster University School of Rehabilitation Science
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Fax
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Email
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Contact person for public queries
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03471247
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