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CYCLE: A Randomized Clinical Trial of Early In-bed Cycling for Mechanically Ventilated Patients
NCT03471247 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DEVICE In-Bed Cycle Ergometer
- OTHER Routine PT
Study Locations (16)
Ontario
- Brant Community Healthcare System - Brantford General Hospital — Brantford
- Hamilton Health Sciences - Hamilton General Hospital — Hamilton
- St. Joseph's Healthcare Hamilton — Hamilton
- Hamilton Health Sciences - Juravinski Hospital — Hamilton
- Kingston Health Sciences Centre - Kingston General Hospital — Kingston
- London Health Sciences Centre - Victoria Hospital — London
- The Ottawa Hospital - General Campus — Ottawa
- The Ottawa Hospital - Civic Campus — Ottawa
- Niagara Health System - St. Catharines Site — St. Catharines
- St. Michael's Hospital — Toronto
Quebec
- Centre Integre de Sante et de Services Sociaux de Chaudiere-Appalaches - Hotel-Dieu de Levis — Lévis
- Centre Integre Universitaire de Sante et de Services Sociaux du Nord-de-L'Ile-de-Montreal - Hopital du Sacre-Coeur de Montreal — Montreal
- Centre Integre Universitaire de Sante et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke — Sherbrooke
Maryland
- University of Maryland Medical Centre — Baltimore
North Carolina
- Duke University Hospital — Durham
Victoria
- Austin Health - Austin Hospital — Heidelberg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2018-10-15 |
| Est. Completion | 2024-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03471247
The ClinicalTrials.gov registry entry for NCT03471247 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is McMaster University, which has 13 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Respiratory Failure appearing as the primary indexed condition, and to 2 interventions — of which In-Bed Cycle Ergometer is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03471247 reports 16 study locations spanning 5 distinct geographic areas — top geographies include Ontario, Quebec, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03471247 about?
NCT03471247 is a clinical study titled "CYCLE: A Randomized Clinical Trial of Early In-bed Cycling for Mechanically Ventilated Patients". 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, allow...
What is the current status of trial NCT03471247?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 360 participants. The study started on 2018-10-15. Estimated completion is 2024-08.
What conditions does trial NCT03471247 study?
This clinical trial studies the following conditions: Respiratory Failure, Mechanical Ventilation, Critical Care, Intensive Care Unit Acquired Weakness. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03471247?
The interventions under investigation include: In-Bed Cycle Ergometer (DEVICE), Routine PT (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03471247?
This trial is sponsored by McMaster University, which has 13 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03471247 being conducted?
This trial has 16 study locations across Maryland, North Carolina, Victoria, Ontario, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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