TryCYCLE: A Pilot Study of Early In-bed Leg Cycle Ergometry in Mechanically Ventilated Patients

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McMaster University

Status

Completed

Conditions

Critical Care
Respiratory Failure
Intensive Care Unit Acquired Weakness
Mechanical Ventilation

Treatments

Device: In-bed leg cycle ergometry

Study type

Interventional

Funder types

Other

Identifiers

NCT01885442
TryCYCLE

Details and patient eligibility

About

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.

Enrollment

33 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

33 participants in 1 patient group

In-bed leg cycle ergometry
Experimental group
Treatment:
Device: In-bed leg cycle ergometry

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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