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CYCLE Pilot Randomized Trial (CYCLE Pilot)

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ClinicalTrials.gov Identifier: NCT02377830
Recruitment Status : Completed
First Posted : March 4, 2015
Last Update Posted : April 17, 2019
Sponsor:
Collaborators:
St. Joseph's Healthcare Hamilton
Hamilton Health Sciences Corporation
Technology Evaluation in the Elderly Network / Canadian Frailty Network
Canadian Institutes of Health Research (CIHR)
Ontario Lung Association
Canadian Respiratory Research Network
Information provided by (Responsible Party):
McMaster University

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 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.


Condition or disease Intervention/treatment Phase
Intensive Care Unit Acquired Weakness Critical Care Mechanical Ventilation Respiratory Failure Device: In-bed cycle ergometer (Restorative Therapies RT300 Supine) Other: Routine physiotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CYCLE Pilot: A Pilot Randomized Study of Early Cycle Ergometry Versus Routine Physiotherapy in Mechanically Ventilated Patients
Actual Study Start Date : March 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: Early Cycling and routine physiotherapy
Patients will receive 30 minutes of in-bed cycling in addition to routine physiotherapy, 5 days per week, for the duration of their ICU stay
Device: In-bed cycle ergometer (Restorative Therapies RT300 Supine)
Other Name: Restorative Therapies RT300 Supine

Active Comparator: Routine physiotherapy
Patients will receive routine physiotherapy per current institutional practice
Other: Routine physiotherapy
activities to assist with optimizing airway clearance and respiratory function, and, based on the patient's alertness and medical stability, activities to maintain or increase limb range of motion and strength, in- and out of bed mobility, and ambulation




Primary Outcome Measures :
  1. Patient accrual [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Cycling protocol violations (% cycling protocol violations) [ Time Frame: 2 years ]
    % cycling protocol violations

  2. Outcome measure ascertainment (% outcomes measured in hospital) [ Time Frame: 2 years ]
    % outcomes measured in hospital

  3. Blinded outcome measures at hospital discharge (% outcomes at hospital discharge measured by blinded outcome assessors) [ Time Frame: 2 years ]
    % outcomes at hospital discharge measured by blinded outcome assessors

  4. Physical Function Test for ICU (PFIT) at ICU awakening, ICU discharge, and hospital discharge [ Time Frame: From study admission to approximately 5, 12 and 30 days, on average, respectively ]
    Patients complete 4 activities: arm and leg strength, ability to stand, and step cadence. Scores range from 0 to 10, with higher scores = better function

  5. Muscle strength at ICU awakening, ICU discharge, and hospital discharge [ Time Frame: From study admission to approximately 5, 12 and 30 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).

  6. Quadriceps strength at ICU and hospital discharge (Force measured in Kg and in Newtons on a continuous scale) [ Time Frame: From study admission to approximately 12 and 30 days, on average, respectively ]
    The patient exerts a force against a small strain gauge that fits in the examiner's hand. .

  7. 2 minute walk test at ICU and hospital discharge [ Time Frame: From study admission to approximately 12 and 30 days, on average, respectively ]
    Maximum distance walked in 2 minutes measured in metres on a continuous scale


Other Outcome Measures:
  1. Katz Activities of Daily Living Scale at ICU and hospital discharge [ Time Frame: From study admission to approximately 12 and 30 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.

  2. Euro-QOL 5DL [ Time Frame: From study admission to approximately 12 and 30 days, on average, respectively ]
    5 question self-administered, preference-based instrument to measure mobility, self-care, usual activities, pain, and anxiety/ depression, as well as a global assessment of health



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults admitted to a medical-surgical ICU within the 1st 4 days of mechanical ventilation (MV) and 1st 7 days of ICU, and
  • could ambulate independently before hospital admission.

Exclusion Criteria:

  • Acute condition impairing patients' ability to cycle (e.g., leg fracture),
  • proven or suspected neuromuscular weakness affecting the legs (e.g., stroke or Guillain-Barré syndrome),
  • unable to follow commands in English pre-ICU,
  • temporary pacemaker,
  • expected hospital mortality >90%,
  • unable to fit the bike, palliative goals of care, or persistent therapy exemptions in the 1st 4 days of MV (e.g., cardiorespiratory instability, active major bleeding)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377830


Locations
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Canada, Ontario
St. Joseph's Healthcare Intensive Care Unit
Hamilton, Ontario, Canada, L8N 4A6
Hamilton Health Sciences General ICU
Hamilton, Ontario, Canada
Hamilton Health Sciences Juravinski ICU
Hamilton, Ontario, Canada
London Health Sciences
London, Ontario, Canada
Ottawa General Hospital
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Sponsors and Collaborators
McMaster University
St. Joseph's Healthcare Hamilton
Hamilton Health Sciences Corporation
Technology Evaluation in the Elderly Network / Canadian Frailty Network
Canadian Institutes of Health Research (CIHR)
Ontario Lung Association
Canadian Respiratory Research Network
Investigators
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Principal Investigator: Michelle Kho, PT, PhD McMaster University School of Rehabilitation Science
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02377830    
Other Study ID Numbers: HIREB 14-531
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases