CYCLE: A Randomized Clinical Trial of Early In-bed Cycling for Mechanically Ventilated Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
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N/A |
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:
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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.
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Device: 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 Names:
Other: 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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| Active Comparator: Routine PT Patients will receive routine physiotherapy interventions per current institutional practice |
Other: 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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Outcome Measures
Primary Outcome Measures
- Physical Function Test for ICU-scored (PFIT-s) [3 days after ICU 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.
Secondary Outcome Measures
- Physical Function Test for ICU-scored (PFIT-s) [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]
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.
- Muscle Strength [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]
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.
- 30 Second Sit to Stand [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]
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.
- Two Minute Walk Test [ICU Discharge, approximately 12 days after ICU admission; 3 days after ICU discharge; Hospital Discharge, approximately 28 days after ICU admission]
Maximum distance walked in 2 minutes measured in metres on a continuous scale.
- Patient-Reported Functional Scale-ICU (PRFS-ICU) [ICU discharge, approximately 12 days after ICU admission; hospital discharge, approximately 28 days after ICU admission; 3 months after enrollment]
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.
- Katz Activities of Daily Living (ADL) Scale [Baseline; ICU discharge, approximately 12 days after ICU admission; hospital discharge, approximately 28 days after ICU admission]
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.
- Clinical Frailty Scale [Baseline; hospital discharge, approximately 28 days after ICU admission]
Patients are ranked on a scale from 1-9 according to level of frailty based on clinical descriptions (1 = very fit, 9 = terminally ill).
- Intensive Care Psychological Assessment Tool (IPAT) [After ICU awakening assessment, approximately 7 days after ICU admission]
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.
- Health-Related Quality of Life - EuroQol-5D-5L [ICU discharge, approximately 12 days after ICU admission; hospital discharge, approximately 28 days after ICU admission; 3 months after enrollment]
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".
- Quality-Adjusted Life Years (QALYs) [3 months after enrollment]
A measure of health outcomes for economic evaluation that incorporates the impact of an intervention on both the quantity and quality of life.
- Mortality [From study admission to 3 months after enrollment]
Death in ICU, hospital, or post-discharge.
- Hospital Discharge Location [Hospital discharge, approximately 28 days after ICU admission]
For survivors: home, inpatient rehabilitation, other hospital, chronic care, assisted living facility, nursing home.
- Healthcare Utilization [From study admission to 3 months after enrollment]
Includes emergency room visits and hospitalizations, family doctor visits, specialist visits and outpatient clinics, other healthcare professional services.
- Intervention and Healthcare Costs [From study admission to 3 months after enrollment]
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.
- Hospital Anxiety and Depression Scale (HADS) [3 months after enrollment]
Patient answers 14 questions related to anxiety and depression. Scores range from 0-21 with higher score indicating more distress.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient is ≥ 18 years of age
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Patient is invasively mechanically ventilated ≤ 4 days
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Expected additional 2 day ICU stay
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Ability to ambulate independently (with or without gait aid) pre-hospital
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ICU length of stay ≤ 7 days
Exclusion Criteria:
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Pre-hospital inability to follow simple commands in local language at baseline
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Acute conditions impairing ability to receive cycling
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Acute proven or suspected central or peripheral neuromuscular weakness
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Temporary pacemaker (internal or external)
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Expected hospital mortality ≥ 90%
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Equipment unable to fit patient's body dimensions
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Palliative goals of care
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Pregnancy
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Specific surgical exclusion as stipulated by surgery or ICU team
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Physician declines
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Cycling exemption not resolved during first 4 days of mechanical ventilation
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Patient already able to march on spot at time of screening
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Maryland Medical Centre | Baltimore | Maryland | United States | 21201 |
| 2 | Duke University Hospital | Durham | North Carolina | United States | 27710 |
| 3 | Austin Health - Austin Hospital | Heidelberg | Victoria | Australia | 3084 |
| 4 | Brant Community Healthcare System - Brantford General Hospital | Brantford | Ontario | Canada | N3R 1G9 |
| 5 | Hamilton Health Sciences - Hamilton General Hospital | Hamilton | Ontario | Canada | L8L 2X2 |
| 6 | St. Joseph's Healthcare Hamilton | Hamilton | Ontario | Canada | L8N 4A6 |
| 7 | Hamilton Health Sciences - Juravinski Hospital | Hamilton | Ontario | Canada | L8V 1C3 |
| 8 | Kingston Health Sciences Centre - Kingston General Hospital | Kingston | Ontario | Canada | K7L 2V7 |
| 9 | London Health Sciences Centre - Victoria Hospital | London | Ontario | Canada | N6A 5W9 |
| 10 | The Ottawa Hospital - General Campus | Ottawa | Ontario | Canada | K1H 8L6 |
| 11 | The Ottawa Hospital - Civic Campus | Ottawa | Ontario | Canada | K1Y 4E9 |
| 12 | Niagara Health System - St. Catharines Site | St. Catharines | Ontario | Canada | L2S 0A9 |
| 13 | St. Michael's Hospital | Toronto | Ontario | Canada | M5B 1W8 |
| 14 | Sinai Health System - Mount Sinai Hospital | Toronto | Ontario | Canada | M5G 1X5 |
| 15 | Centre Integre de Sante et de Services Sociaux de Chaudiere-Appalaches - Hotel-Dieu de Levis | Lévis | Quebec | Canada | G6V 3Z1 |
| 16 | Centre Integre Universitaire de Sante et de Services Sociaux du Nord-de-L'Ile-de-Montreal - Hopital du Sacre-Coeur de Montreal | Montréal | Quebec | Canada | H4J 1C5 |
| 17 | Centre Integre Universitaire de Sante et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke | Sherbrooke | Quebec | Canada | J1H 5N4 |
Sponsors and Collaborators
- McMaster University
- St. Joseph's Healthcare Hamilton
- Canadian Institutes of Health Research (CIHR)
- Canadian Critical Care Trials Group
Investigators
- Principal Investigator: Michelle Kho, PT, PhD, McMaster University School of Rehabilitation Science
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CYCLE RCT