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CYCLE: A Randomized Clinical Trial of Early In-bed Cycling for Mechanically Ventilated Patients
Sponsor: McMaster University
Summary
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.
Official title: CYCLE RCT: An International, Multi-centre, Randomized Clinical Trial of Early In-bed Cycling for Mechanically Ventilated Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2018-10-15
Completion Date
2024-08
Last Updated
2024-05-03
Healthy Volunteers
No
Conditions
Interventions
In-Bed Cycle Ergometer
Physiotherapists will place the patient's legs in a specialized in-bed cycle ergometer allowing for gentle leg exercise. Exercise can performed in passive, active-assisted, or active mode.
Routine PT
Includes, 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, ambulation, and assistance with optimizing airway clearance and respiratory function.
Locations (16)
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