CYCLE Pilot Randomized Trial

Completed · Phase 2

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

In brief

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).

Key facts

Study ID

NCT02377830

Run by

McMaster University

People needed

113

Starts

2015-03-01

Expected to finish

2018-12-01

Last updated by the study team

2022-12-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.