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Intensive Care Unit Acquired Weakness | TryCYCLE: A Pilot Study of Early In-bed Leg Cycle Ergometry in Mechanically Ventilated Patients

Intensive Care Unit Acquired Weakness research study

What is the primary objective of this study?

Background: Patients in the intensive care unit (ICU) are the sickest in hospital, and need advanced life-support. Survivors of critical illness are very vulnerable to weakness and disability. 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 employs special equipment that attaches to a patient's hospital bed, allowing them gentle leg exercise while in the ICU. The investigators will offer patients in-bed cycling while they are needing a breathing machine, to help them recover from weakness as fast as possible. Before doing a larger trial testing if in-bed cycling reduces disability, data on safety (Is it safe?) and feasibility (Can the investigators do it?) are needed. Objectives: To study the safety and feasibility of in-bed leg cycling in critically ill patients who need breathing machines. Methods: Adult patients admitted to the ICU who need a breathing machine and are expected to survive their ICU stay are eligible. Specially trained physiotherapists will provide patients with 30 minutes of in-bed cycling each day while they are in the ICU. Outcomes: The investigators will study (1) Safety: the heart rate and breathing patterns of patients doing in-bed cycling, while carefully monitoring for safety. (2) Feasibility: 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 the investigators can assess patients' strength in the ICU and at hospital discharge. Relevance: As the Canadian population ages, the demand for breathing machines during acute illness will increase dramatically. Effective methods of physiotherapy are needed for critically ill patients to minimize muscle weakness, speed recovery, and improve quality of life. This pilot study is the first of several future larger studies about in-bed cycling in the ICU. This program of research will help patients needing life support to regain their strength and recover as fast as possible from critical illness.

Who is eligible to participate?

Inclusion Criteria: - Adult patients ≥18 years old - Invasively mechanically ventilated ≤4 days - Expected additional 2 day ICU stay - Ability to ambulate independently pre-hospital (with or without a gait aid) Exclusion Criteria: - Unable to follow simple commands at baseline - Pregnancy - Acute conditions impairing ability to walk or cycle (e.g., leg or foot fracture) - Acute central condition or peripheral injury resulting in neuromuscular weakness (e.g., stroke, Guillain Barré syndrome) - Primary generalized weakness of the central or peripheral nervous system (e.g., multiple sclerosis, myasthenia gravis, Parkinson's disease, amyotrophic lateral sclerosis) - Temporary pacemaker wires - Expected hospital mortality> 90% - Cycling equipment unable to fit patient's body dimensions (e.g., leg amputation or obesity) - Specific surgical exclusion as stipulated by attending ->7 day ICU stay - Physician declines - Patient did not meet daily screening criteria to provide in-bed leg cycling during the first 4 days of mechanical ventilation

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Intensive Care Unit Acquired Weakness

Critical Care

Mechanical Ventilation

Respiratory Failure

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:In-bed leg cycle ergometryPatients will receive 30 minutes of in-bed leg cycling in addition to routine physiotherapy, 6 days per week, for the duration of their ICU stay (to a maximum of 28 days).

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

In-bed leg cycle ergometry

Study Status

Completed

Start Date: September 2013

Completed Date: January 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Number of in-bed leg cycling research sessions terminated (composite outcome)

Secondary Outcome: Number of adverse events: Intravascular catheter or tube dislodgement rate during in-bed cycling

Study sponsors, principal investigator, and references

Principal Investigator: Michelle E Kho, PT, PhD

Lead Sponsor: McMaster University

Collaborator: St. Joseph's Healthcare Hamilton

More information:https://clinicaltrials.gov/show/NCT01885442

Kho ME, Molloy AJ, McCaughan M, et al. TryCYCLE: Preliminary results of early in-bed cycling with mechanically ventilated patients. Crit Care Med 2014;43.

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