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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Intensive Care Unit Acquired Weakness, Critical Care, Mechanical Ventilation, Respiratory Failure

Intervention / Treatment
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* Device: In-bed leg cycle ergometry


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: In-bed leg cycle ergometry<br> | Device: In-bed leg cycle ergometry<br>* 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).<br>* Other names: RT300 Supine Cycle Ergometer (Restorative Therapies, Baltimore, MD);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events: Intravascular catheter or tube dislodgement rate during in-bed cycling | Any of the following catheter or tube dislodgements: Catheters: Central venous, arterial, dialysis, or pulmonary artery catheter Tubes: Orogastric, nasogastric, or percutaneous endoscopic gastrostomy | From date of enrollment until date of ICU discharge, approximately 10 days on average | 
| Daily research session delivery rate | 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%). | 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 | We will calculate the binary proportion and 95% confidence interval for outcome measure ascertainment event rates. | 5 days after study admission, on average | 
| Rate of outcome measure ascertainment in assessable patients at ICU discharge | We will calculate the binary proportion and 95% confidence interval for outcome measure ascertainment event rates. | 10 days after study admission, on average | 
| Rate of outcome measure ascertainment in assessable patients at hospital discharge | We will calculate the binary proportion and 95% confidence interval for outcome measure ascertainment event rates. | 15 days after study admission, on average | 
| Consent rate feasibility | Consent rate | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mechanical ventilation, cycle ergometry, intensive care unit, rehabilitation