Clinical trial NCT01885442: TryCYCLE: A Pilot Study of Early In-bed Leg Cycle Ergometry in Mechanically Ventilated Patients
Official title: TryCYCLE (Critical Care Cycling to Improve Lower Extremity Strength): A Prospective Pilot Study of the Safety and Feasibility of Early In-bed Leg Cycle Ergometry in Mechanically Ventilated Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intensive Care Unit Acquired Weakness
Critical Care
Mechanical Ventilation
Respiratory Failure
Keywords: mechanical ventilation
cycle ergometry
intensive care unit
rehabilitation
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: St. Joseph's Healthcare Hamilton
First posted: 2013-06-25
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of in-bed leg cycling research sessions terminated (composite outcome)
timeFrame: From date of enrollment until date of ICU discharge, approximately 10 days on average
Secondary outcomes:
measure: Number of adverse events: Intravascular catheter or tube dislodgement rate during in-bed cycling
timeFrame: From date of enrollment until date of ICU discharge, approximately 10 days on average
measure: Daily research session delivery rate
timeFrame: From date of enrollment until date of ICU discharge, approximately 10 days on average
measure: Rate of outcome measure ascertainment in assessable patients at ICU awakening
timeFrame: 5 days after study admission, on average
measure: Rate of outcome measure ascertainment in assessable patients at ICU discharge
timeFrame: 10 days after study admission, on average
measure: Rate of outcome measure ascertainment in assessable patients at hospital discharge
timeFrame: 15 days after study admission, on average
measure: Consent rate feasibility
timeFrame: 1 year
Other outcomes:
measure: Leg and overall body strength at ICU awakening, ICU discharge, and hospital discharge
timeFrame: From study admission to approximately 5, 10, and 15 days, on average, respectively
measure: Quadriceps Leg Strength - hand held dynamometer at ICU awakening, ICU discharge, and hospital discharge
timeFrame: From study admission to approximately 5, 10, and 15 days, on average, respectively
measure: Grip Strength - Hand grip dynamometer at ICU awakening, ICU discharge, and hospital discharge
timeFrame: From study admission to approximately 5, 10, and 15 days, on average, respectively
measure: Functional Status Scale for ICU at ICU awakening ICU, ICU discharge, and hospital discharge
timeFrame: From study admission to approximately 5, 10, and 15 days, on average, respectively
measure: Katz Activities of Daily Living Scale at ICU awakening, ICU discharge, and hospital discharge
timeFrame: From study admission to approximately 5, 10, and 15 days, on average, respectively
measure: Physical Function Test for ICU at ICU awakening, ICU discharge, and hospital discharge
timeFrame: ICU awakening, ICU discharge, From study admission to approximately 5, 10, and 15 days, on average, respectively
measure: Patient-Specific Functional Scale at ICU awakening, ICU discharge, and hospital discharge
timeFrame: From study admission to approximately 5, 10, and 15 days, on average, respectively
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Intensive Care Unit
state: Ontario
Study officials:
affiliation: McMaster University
name: Michelle E Kho, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Kho ME, Molloy AJ, Clarke FJ, Ajami D, McCaughan M, Obrovac K, Murphy C, Camposilvan L, Herridge MS, Koo KK, Rudkowski J, Seely AJ, Zanni JM, Mourtzakis M, Piraino T, Cook DJ; Canadian Critical Care Trials Group. TryCYCLE: A Prospective Study of the Safety and Feasibility of Early In-Bed Cycling in Mechanically Ventilated Patients. PLoS One. 2016 Dec 28;11(12):e0167561. doi: 10.1371/journal.pone.0167561. eCollection 2016.