CYCLE Pilot Randomized Trial

Study Overview
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Brief Summary
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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).

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

Conditions
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Intensive Care Unit Acquired Weakness, Critical Care, Mechanical Ventilation, Respiratory Failure

Intervention / Treatment
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* Device: In-bed cycle ergometer (Restorative Therapies RT300 Supine)
* Other: Routine physiotherapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Cycling and routine physiotherapy<br>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)<br> <br> * Other names: Restorative Therapies RT300 Supine;|
| Active Comparator: Routine physiotherapy<br>Patients will receive routine physiotherapy per current institutional practice | Other: Routine physiotherapy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |