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ACTIVE NOT RECRUITING
NCT03471247
NA

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

Sponsor: McMaster University

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

OTHER

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