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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
113
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
Duke University Medical Center
Durham, North Carolina, United States
Austin Health
Melbourne, Victoria, Australia
St. Joseph's Healthcare Intensive Care Unit
Hamilton, Ontario, Canada
Hamilton Health Sciences General ICU
Hamilton, Ontario, Canada
Hamilton Health Sciences Juravinski ICU
Hamilton, Ontario, Canada
London Health Sciences
London, Ontario, Canada
Ottawa General Hospital
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Patient accrual
Time frame: 2 years
Cycling protocol violations (% cycling protocol violations)
% cycling protocol violations
Time frame: 2 years
Outcome measure ascertainment (% outcomes measured in hospital)
% outcomes measured in hospital
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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. .
Time frame: 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
Time frame: From study admission to approximately 12 and 30 days, on average, respectively
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