CYCLE: A Randomized Clinical Trial of Early In-bed Cycling for Mechanically Ventilated Patients

Status unconfirmed · Not applicable

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

In brief

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.

Key facts

Study ID

NCT03471247

Run by

McMaster University

People needed

360

Starts

2018-10-15

Expected to finish

2024-08-01

Last updated by the study team

2024-05-03

Who can join

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

You may qualify if…

• 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) before their critical illness
• ICU length of stay ≤ 7 days

You may not qualify if…

• Pre-hospital inability to follow simple commands in local language at baseline
• Acute conditions impairing ability to receive cycling
• Severe cognitive impairment pre-ICU
• Traumatic brain injury
• Acute proven or suspected central or peripheral neuromuscular weakness affecting the legs (e.g., stroke, Guillian-Barre syndrome, spinal injury)
• Temporary pacemaker (internal or external)
• Expected hospital mortality ≥ 90%
• Equipment unable to fit patient's body dimensions (elg., leg amputation, morbid obesity)
• Palliative goals of care
• Pregnancy (suspected or proven)
• 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

Where it is running

• University of Maryland Medical Centre — Baltimore, Maryland, United States
• Duke University Hospital — Durham, North Carolina, United States
• Austin Health - Austin Hospital — Heidelberg, Victoria, Australia
• Brant Community Healthcare System - Brantford General Hospital — Brantford, Ontario, Canada
• Hamilton Health Sciences - Hamilton General Hospital — Hamilton, Ontario, Canada
• St. Joseph's Healthcare Hamilton — Hamilton, Ontario, Canada
• Hamilton Health Sciences - Juravinski Hospital — Hamilton, Ontario, Canada
• Kingston Health Sciences Centre - Kingston General Hospital — Kingston, Ontario, Canada
• London Health Sciences Centre - Victoria Hospital — London, Ontario, Canada
• The Ottawa Hospital - General Campus — Ottawa, Ontario, Canada
• The Ottawa Hospital - Civic Campus — Ottawa, Ontario, Canada
• Niagara Health System - St. Catharines Site — St. Catharines, Ontario, Canada
• St. Michael's Hospital — Toronto, Ontario, Canada
• Centre Integre de Sante et de Services Sociaux de Chaudiere-Appalaches - Hotel-Dieu de Levis — Lévis, Quebec, Canada
• Centre Integre Universitaire de Sante et de Services Sociaux du Nord-de-L'Ile-de-Montreal - Hopital du Sacre-Coeur de Montreal — Montreal, Quebec, Canada
• Centre Integre Universitaire de Sante et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke — Sherbrooke, Quebec, Canada

Full record on ClinicalTrials.gov

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