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

NCT01885442 | Completed DMC

• 1 other identifier: TryCYCLE
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Intensive Care Unit Acquired Weakness; Critical Care; Mechanical Ventilation; Respiratory Failure

Keywords

mechanical ventilation; cycle ergometry; intensive care unit; rehabilitation

Outcome Measures

Primary Outcomes (1)

• Number of in-bed leg cycling research sessions terminated (composite outcome)

  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

  From date of enrollment until date of ICU discharge, approximately 10 days on average

Secondary Outcomes (6)

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

  From date of enrollment until date of ICU discharge, approximately 10 days on average

• Daily research session delivery rate

  From date of enrollment until date of ICU discharge, approximately 10 days on average

• Rate of outcome measure ascertainment in assessable patients at ICU awakening

  5 days after study admission, on average

• Rate of outcome measure ascertainment in assessable patients at ICU discharge

  10 days after study admission, on average

• Rate of outcome measure ascertainment in assessable patients at hospital discharge

  15 days after study admission, on average

Other Outcomes (7)

• Leg and overall body strength at ICU awakening, ICU discharge, and hospital discharge

  From study admission to approximately 5, 10, and 15 days, on average, respectively

• Quadriceps Leg Strength - hand held dynamometer at ICU awakening, ICU discharge, and hospital discharge

  From study admission to approximately 5, 10, and 15 days, on average, respectively

• Grip Strength - Hand grip dynamometer at ICU awakening, ICU discharge, and hospital discharge

  From study admission to approximately 5, 10, and 15 days, on average, respectively

Study Arms (1)

In-bed leg cycle ergometry

EXPERIMENTAL

Device: In-bed leg cycle ergometry

Interventions

In-bed leg cycle ergometry DEVICE

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).

Also known as: RT300 Supine Cycle Ergometer (Restorative Therapies, Baltimore, MD)

In-bed leg cycle ergometry

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• \>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

Sponsors & Collaborators

• McMaster University: lead
• St. Joseph's Healthcare Hamilton: collaborator

Study Sites (1)

St. Joseph's Healthcare Intensive Care Unit

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (2)

• 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.

  BACKGROUND

• 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.

  PMID: 28030555 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Michelle E Kho, PT, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: June 25, 2013
• Study Start: September 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: January 1, 2015
• Last Updated: April 6, 2016

Record last verified: 2016-04

Locations

CA (1)