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NCT02377830 · ClinicalTrials.gov registry record · Phase 2

CYCLE Pilot Randomized Trial

A Phase 2 study of Respiratory Failure and Mechanical Ventilation, sponsored by McMaster University.

Completed
Registry status
Phase 2
Development phase
113
Enrollment target
9
Study locations

NCT02377830: Completed Phase 2 study of Respiratory Failure and Mechanical Ventilation, sponsored by McMaster University.

NCT02377830 is a Phase 2 study of Respiratory Failure and Mechanical Ventilation that has completed, run by McMaster University. The registered enrollment target is 113 participants, below the 4,521-participant average among 40 other Respiratory Failure trials with a reported enrollment target (98% lower). The trial reports 9 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02377830, a Phase 2 study of Respiratory Failure and Mechanical Ventilation, has completed, sponsored by McMaster University.

COMPLETED
Registry status
Phase 2
Development phase
113 participants
Enrollment target
9
Study locations

Study Summary

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).

Conditions Studied

Respiratory Failure Mechanical Ventilation Critical Care Intensive Care Unit Acquired Weakness

Interventions

  • DEVICE In-bed cycle ergometer (Restorative Therapies RT300 Supine)
  • OTHER Routine physiotherapy

Study Locations (9)

Ontario

  • St. Joseph's Healthcare Intensive Care Unit - Hamilton
  • Hamilton Health Sciences General ICU - Hamilton
  • Hamilton Health Sciences Juravinski ICU - Hamilton
  • London Health Sciences - London
  • Ottawa General Hospital - Ottawa
  • St. Michael's Hospital - Toronto
  • Toronto General Hospital - Toronto

North Carolina

  • Duke University Medical Center - Durham

Victoria

  • Austin Health - Melbourne

Trial Details

FieldValue
Enrollment Target 113 participants
Start Date 2015-03
Est. Completion 2018-12
Phase Phase 2
McMaster University

31 total trials

What the finished NCT02377830 record still lists

NCT02377830 is an interventional study that assigns participants to a tested intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap, below the 4,521-participant average among 40 other Respiratory Failure trials with a reported enrollment target (98% lower).

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 (Restorative Therapies RT300 Supine) is the first listed.

NCT02377830 lists 9 locations in 3 states (Ontario, North Carolina, Victoria).

Frequently Asked Questions

What is clinical trial NCT02377830 about?

NCT02377830 is a clinical study titled "CYCLE Pilot Randomized Trial". 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 cyclin...

What is the current status of trial NCT02377830?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 113 participants. The study started on 2015-03. Estimated completion is 2018-12.

What conditions does trial NCT02377830 study?

This clinical trial studies the following conditions: Respiratory Failure, Mechanical Ventilation, Critical Care, Intensive Care Unit Acquired Weakness.

What interventions are being tested in trial NCT02377830?

The interventions under investigation include: In-bed cycle ergometer (Restorative Therapies RT300 Supine) (DEVICE), Routine physiotherapy (OTHER).

Who is sponsoring clinical trial NCT02377830?

This trial is sponsored by McMaster University, which has 31 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02377830 being conducted?

This trial has 9 study locations across North Carolina, Victoria, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Respiratory Failure

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02377830's enrollment target sits among peer trials

113 24th of 40 higher than 17 of 40 other Respiratory Failure trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Respiratory Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT02377830, the US trial registry maintained by the National Library of Medicine. NCT02377830 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.