CYCLE Pilot Randomized Trial (CYCLE Pilot)
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| ClinicalTrials.gov Identifier: NCT02377830 |
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Recruitment Status :
Completed
First Posted : March 4, 2015
Last Update Posted : December 5, 2022
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Intensive Care Unit Acquired Weakness Critical Care Mechanical Ventilation Respiratory Failure | Device: In-bed cycle ergometer (Restorative Therapies RT300 Supine) Other: Routine physiotherapy | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 113 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | CYCLE Pilot: A Pilot Randomized Study of Early Cycle Ergometry Versus Routine Physiotherapy in Mechanically Ventilated Patients |
| Actual Study Start Date : | March 2015 |
| Actual Primary Completion Date : | March 2018 |
| Actual Study Completion Date : | December 2018 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Early Cycling and routine physiotherapy
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
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Device: In-bed cycle ergometer (Restorative Therapies RT300 Supine)
Other Name: Restorative Therapies RT300 Supine |
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Active Comparator: Routine physiotherapy
Patients will receive routine physiotherapy per current institutional practice
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Other: Routine physiotherapy
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 |
- Patient accrual [ Time Frame: 2 years ]
- Cycling protocol violations (% cycling protocol violations) [ Time Frame: 2 years ]% cycling protocol violations
- Outcome measure ascertainment (% outcomes measured in hospital) [ Time Frame: 2 years ]% outcomes measured in hospital
- Blinded outcome measures at hospital discharge (% outcomes at hospital discharge measured by blinded outcome assessors) [ Time Frame: 2 years ]% outcomes at hospital discharge measured by blinded outcome assessors
- Physical Function Test for ICU (PFIT) at ICU awakening, ICU discharge, 3-days post-ICU discharge (CYCLE Vanguard only) and hospital discharge [ Time Frame: From study admission to approximately 5, 12, 15 and 30 days, on average, respectively ]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 at ICU awakening, ICU discharge, 3-days post-ICU discharge (CYCLE Vanguard only), and hospital discharge [ Time Frame: From study admission to approximately 5, 12, 15 and 30 days, on average, respectively ]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).
- Quadriceps strength at ICU and hospital discharge (Force measured in Kg and in Newtons on a continuous scale) [ Time Frame: From study admission to approximately 12 and 30 days, on average, respectively ]The patient exerts a force against a small strain gauge that fits in the examiner's hand. .
- 2 minute walk test at ICU discharge, 3-days post-ICU (CYCLE Vanguard only), and hospital discharge [ Time Frame: From study admission to approximately 12 and 30 days, on average, respectively ]Maximum distance walked in 2 minutes measured in metres on a continuous scale
- Katz Activities of Daily Living Scale at ICU and hospital discharge [ Time Frame: From study admission to approximately 12 and 30 days, on average, respectively ]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.
- Euro-QOL 5DL [ Time Frame: From study admission to approximately 12 and 30 days, on average, respectively ]5 question self-administered, preference-based instrument to measure mobility, self-care, usual activities, pain, and anxiety/ depression, as well as a global assessment of health
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377830
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| Australia, Victoria | |
| Austin Health | |
| Melbourne, Victoria, Australia, 3084 | |
| Canada, Ontario | |
| St. Joseph's Healthcare Intensive Care Unit | |
| Hamilton, Ontario, Canada, L8N 4A6 | |
| 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 | |
| Principal Investigator: | Michelle Kho, PT, PhD | McMaster University School of Rehabilitation Science |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | McMaster University |
| ClinicalTrials.gov Identifier: | NCT02377830 |
| Other Study ID Numbers: |
HIREB 14-531 |
| First Posted: | March 4, 2015 Key Record Dates |
| Last Update Posted: | December 5, 2022 |
| Last Verified: | November 2022 |
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Respiratory Insufficiency Respiration Disorders Respiratory Tract Diseases |