CYCLE: A Randomized Clinical Trial of Early In-bed Cycling for Mechanically Ventilated Patients
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Hospital, Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/20/2019 |
| Start Date: | October 15, 2018 |
| End Date: | December 2021 |
| Contact: | Michelle Kho, PT, PhD |
| Email: | khome@mcmaster.ca |
| Phone: | 905-525-9140 |
CYCLE RCT: An International, Multi-centre, Randomized Clinical Trial of Early In-bed Cycling for Mechanically Ventilated Patients
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.
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:
1. 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.
2. 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.
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:
1. 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.
2. 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.
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) pre-hospital
- ICU length of stay ≤ 7 days
Exclusion Criteria:
- Pre-hospital inability to follow simple commands in local language at baseline
- Acute conditions impairing ability to receive cycling
- Acute proven or suspected central or peripheral neuromuscular weakness
- Temporary pacemaker (internal or external)
- Expected hospital mortality ≥ 90%
- Equipment unable to fit patient's body dimensions
- Palliative goals of care
- Pregnancy
- 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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