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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01885442
Recruitment Status : Completed
First Posted : June 25, 2013
Last Update Posted : April 6, 2016
Sponsor:
Collaborator:
St. Joseph's Healthcare Hamilton
Information provided by (Responsible Party):
McMaster University

Tracking Information
First Submitted Date  ICMJE March 21, 2013
First Posted Date  ICMJE June 25, 2013
Last Update Posted Date April 6, 2016
Study Start Date  ICMJE September 2013
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2013)
Number of in-bed leg cycling research sessions terminated (composite outcome) [ Time Frame: From date of enrollment until date of ICU discharge, approximately 10 days on average ]
Research sessions will stop if the patient meets any of the following criteria:
  • Sustained oxygen desaturation <88%, despite adjustments to FiO2
  • Heart rate
    • Low: 20 bpm less than lowest baseline value or 40 bpm (whichever is highest)
    • High: 20 bpm more than highest baseline value or 140 bpm (whichever is lowest)
  • Mean Arterial Pressure <55 or >110 mmHg
  • Marked ventilator dyssynchrony not corrected by adjusting cycle off criteria
Safety events:
  • Suspected new unstable / uncontrolled arrhythmia
  • Concern for myocardial ischaemia
  • Respiratory distress leading to symptoms of intolerable dyspnea
  • Unplanned extubation Any of the following catheter or tube dislodgements
  • Catheters: Central venous, arterial, dialysis, or pulmonary artery catheter
  • Tubes: Orogastric, nasogastric, or percutaneous endoscopic gastrostomy
ICU physician, patient or proxy requests termination of session
Original Primary Outcome Measures  ICMJE
 (submitted: June 20, 2013)
Number of in-bed leg cycling research sessions terminated (composite outcome) [ Time Frame: From date of enrollment until date of ICU discharge, approximately 10 days on average ]
Research sessions will stop if the patient meets any of the following criteria:
  • Sustained oxygen desaturation <88%, despite adjustments to FiO2
  • Heart rate
    • Low: 20 bpm less than lowest baseline value or 40 bpm (whichever is highest)
    • High: 20 bpm more than highest baseline value or 140 bpm (whichever is lowest)
  • Mean Arterial Pressure <55 or >110 mmHg
  • Marked ventilator dysynchrony not corrected by adjusting cycle off criteria
Safety events:
  • Suspected new unstable / uncontrolled arrhythmia
  • Concern for myocardial ischaemia
  • Respiratory distress leading to symptoms of intolerable dyspnea
  • Unplanned extubation Any of the following catheter or tube dislodgements
  • Catheters: Central venous, arterial, dialysis, or pulmonary artery catheter
  • Tubes: Orogastric, nasogastric, or percutaneous endoscopic gastrostomy
ICU physician, patient or proxy requests termination of session
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2013)
  • Number of adverse events: Intravascular catheter or tube dislodgement rate during in-bed cycling [ Time Frame: From date of enrollment until date of ICU discharge, approximately 10 days on average ]
    Any of the following catheter or tube dislodgements:
    • Catheters: Central venous, arterial, dialysis, or pulmonary artery catheter
    • Tubes: Orogastric, nasogastric, or percutaneous endoscopic gastrostomy
  • Daily research session delivery rate [ Time Frame: From date of enrollment until date of ICU discharge, approximately 10 days on average ]
    We will assess our ability to deliver cycling during the ICU stay by comparing our daily delivery rate with that achieved in ICU rehabilitation randomized clinical trials (80%).
  • Rate of outcome measure ascertainment in assessable patients at ICU awakening [ Time Frame: 5 days after study admission, on average ]
    We will calculate the binary proportion and 95% confidence interval for outcome measure ascertainment event rates.
  • Rate of outcome measure ascertainment in assessable patients at ICU discharge [ Time Frame: 10 days after study admission, on average ]
    We will calculate the binary proportion and 95% confidence interval for outcome measure ascertainment event rates.
  • Rate of outcome measure ascertainment in assessable patients at hospital discharge [ Time Frame: 15 days after study admission, on average ]
    We will calculate the binary proportion and 95% confidence interval for outcome measure ascertainment event rates.
  • Consent rate feasibility [ Time Frame: 1 year ]
    Consent rate
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 20, 2013)
  • Leg and overall body strength at ICU awakening, ICU discharge, and hospital discharge [ Time Frame: From study admission to approximately 5, 10, and 15 days, on average, respectively ]
    Manual muscle testing using the Medical Research Council (MRC) Scale. The patient exerts a force against the examiner's resistance. Each muscle is assessed on a 6-point MRC scale (0=no contraction; 5=contraction sustained against maximal resistance).
  • Quadriceps Leg Strength - hand held dynamometer at ICU awakening, ICU discharge, and hospital discharge [ Time Frame: From study admission to approximately 5, 10, and 15 days, on average, respectively ]
    The patient exerts a force against a small strain gauge that fits in the examiner's hand. Force measured in Kg and in Newtons on a continuous scale.
  • Grip Strength - Hand grip dynamometer at ICU awakening, ICU discharge, and hospital discharge [ Time Frame: From study admission to approximately 5, 10, and 15 days, on average, respectively ]
    Force measured in Kg. Force measured in Kg and in Newtons on a continuous scale.
  • Functional Status Scale for ICU at ICU awakening ICU, ICU discharge, and hospital discharge [ Time Frame: From study admission to approximately 5, 10, and 15 days, on average, respectively ]
    The patient attempts 5 bed mobility/ transfer tasks: rolling, supine to sit, sitting at edge of be, transfer from sit to stand, ambulation. Each item assessed on a scale from 0 (unable to perform) to 7 (independent).
  • Katz Activities of Daily Living Scale at ICU awakening, ICU discharge, and hospital discharge [ Time Frame: From study admission to approximately 5, 10, and 15 days, on average, respectively ]
    The patient's ability to complete 6 tasks: bathing, dressing, toileting, feeding, continence, and bed mobility. A rater assesses whether the patient is dependent or independent according to pre-specified criteria.
  • Physical Function Test for ICU at ICU awakening, ICU discharge, and hospital discharge [ Time Frame: ICU awakening, ICU discharge, From study admission to approximately 5, 10, and 15 days, on average, respectively ]
    The patient completes 4 tasks: sit to stand, marching on the spot, repeated bilateral shoulder flexion, and muscle strength assessment (knee extension, shoulder flexion).
  • Patient-Specific Functional Scale at ICU awakening, ICU discharge, and hospital discharge [ Time Frame: From study admission to approximately 5, 10, and 15 days, on average, respectively ]
    The patient rates their ability to complete a specific task on a scale from 0 (unable to perform activity) to 10 (able to perform activity at baseline level).
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE TryCYCLE: A Pilot Study of Early In-bed Leg Cycle Ergometry in Mechanically Ventilated Patients
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Intensive Care Unit Acquired Weakness
  • Critical Care
  • Mechanical Ventilation
  • Respiratory Failure
Intervention  ICMJE Device: In-bed leg cycle ergometry
Patients 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).
Other Name: RT300 Supine Cycle Ergometer (Restorative Therapies, Baltimore, MD)
Study Arms  ICMJE Experimental: In-bed leg cycle ergometry
Intervention: Device: In-bed leg cycle ergometry
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2013)
33
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01885442
Other Study ID Numbers  ICMJE TryCYCLE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party McMaster University
Study Sponsor  ICMJE McMaster University
Collaborators  ICMJE St. Joseph's Healthcare Hamilton
Investigators  ICMJE
Principal Investigator: Michelle E Kho, PT, PhD McMaster University
PRS Account McMaster University
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP