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

Respiratory Failure Clinical Trial

— TryCYCLE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01885442
• Other study ID #: TryCYCLE
• Status: Completed
• Phase: N/A
• First received: March 21, 2013
• Last updated: April 4, 2016
• Start date: September 2013
• Est. completion date: January 2015

Study information

• Verified date: April 2016
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Care
• Intensive Care Unit Acquired Weakness
• Mechanical Ventilation
• Respiratory Failure
• Respiratory Insufficiency

Intervention

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).

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Intensive Care Unit	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Leg and overall body strength at ICU awakening, ICU discharge, and hospital discharge	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).	From study admission to approximately 5, 10, and 15 days, on average, respectively	No
Other	Quadriceps Leg Strength - hand held dynamometer at ICU awakening, ICU discharge, and hospital discharge	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.	From study admission to approximately 5, 10, and 15 days, on average, respectively	No
Other	Grip Strength - Hand grip dynamometer at ICU awakening, ICU discharge, and hospital discharge	Force measured in Kg. Force measured in Kg and in Newtons on a continuous scale.	From study admission to approximately 5, 10, and 15 days, on average, respectively	No
Other	Functional Status Scale for ICU at ICU awakening ICU, ICU discharge, and hospital discharge	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).	From study admission to approximately 5, 10, and 15 days, on average, respectively	No
Other	Katz Activities of Daily Living Scale at ICU awakening, ICU discharge, and hospital discharge	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.	From study admission to approximately 5, 10, and 15 days, on average, respectively	No
Other	Physical Function Test for ICU at ICU awakening, ICU discharge, and hospital discharge	The patient completes 4 tasks: sit to stand, marching on the spot, repeated bilateral shoulder flexion, and muscle strength assessment (knee extension, shoulder flexion).	ICU awakening, ICU discharge, From study admission to approximately 5, 10, and 15 days, on average, respectively	No
Other	Patient-Specific Functional Scale at ICU awakening, ICU discharge, and hospital discharge	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).	From study admission to approximately 5, 10, and 15 days, on average, respectively	No
Primary	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	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Consent rate feasibility	Consent rate	1 year	No