Clinical trial NCT02377830: CYCLE Pilot Randomized Trial
Official title: CYCLE Pilot: A Pilot Randomized Study of Early Cycle Ergometry Versus Routine Physiotherapy in Mechanically Ventilated Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Intensive Care Unit Acquired Weakness
Critical Care
Mechanical Ventilation
Respiratory Failure
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: St. Joseph's Healthcare Hamilton
name: Hamilton Health Sciences Corporation
name: Technology Evaluation in the Elderly Network / Canadian Frailty Network
name: Canadian Institutes of Health Research (CIHR)
name: Ontario Lung Association
name: Canadian Respiratory Research Network
First posted: 2015-03-04
Enrollment: 113
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Our pilot work includes CYCLE Pilot and CYCLE Vanguard. CYCLE Pilot is an external pilot and enrolled 66 patients from 3/2015 to 6/2016. CYCLE Vanguard is an internal pilot and enrolled 47 patients from 11/2016 to 3/2018. CYCLE Vanguard patients will be analyzed in the main CYCLE RCT (NCT03471247).


Eligibility 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)

Primary outcomes:
measure: Patient accrual
timeFrame: 2 years
Secondary outcomes:
measure: Cycling protocol violations (% cycling protocol violations)
timeFrame: 2 years
measure: Outcome measure ascertainment (% outcomes measured in hospital)
timeFrame: 2 years
measure: Blinded outcome measures at hospital discharge (% outcomes at hospital discharge measured by blinded outcome assessors)
timeFrame: 2 years
measure: Physical Function Test for ICU (PFIT) at ICU awakening, ICU discharge, 3-days post-ICU discharge (CYCLE Vanguard only) and hospital discharge
timeFrame: From study admission to approximately 5, 12, 15 and 30 days, on average, respectively
measure: Muscle strength at ICU awakening, ICU discharge, 3-days post-ICU discharge (CYCLE Vanguard only), and hospital discharge
timeFrame: From study admission to approximately 5, 12, 15 and 30 days, on average, respectively
measure: Quadriceps strength at ICU and hospital discharge (Force measured in Kg and in Newtons on a continuous scale)
timeFrame: From study admission to approximately 12 and 30 days, on average, respectively
measure: 2 minute walk test at ICU discharge, 3-days post-ICU (CYCLE Vanguard only), and hospital discharge
timeFrame: From study admission to approximately 12 and 30 days, on average, respectively
Other outcomes:
measure: Katz Activities of Daily Living Scale at ICU and hospital discharge
timeFrame: From study admission to approximately 12 and 30 days, on average, respectively
measure: Euro-QOL 5DL
timeFrame: From study admission to approximately 12 and 30 days, on average, respectively
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Melbourne
country: Australia
facility: Austin Health
state: Victoria
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Intensive Care Unit
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Health Sciences General ICU
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Juravinski ICU
state: Ontario
city: London
country: Canada
facility: London Health Sciences
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa General Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
Study officials:
affiliation: McMaster University School of Rehabilitation Science
name: Michelle Kho, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kho ME, Molloy AJ, Clarke FJ, Reid JC, Herridge MS, Karachi T, Rochwerg B, Fox-Robichaud AE, Seely AJ, Mathur S, Lo V, Burns KE, Ball IM, Pellizzari JR, Tarride JE, Rudkowski JC, Koo K, Heels-Ansdell D, Cook DJ. Multicentre pilot randomised clinical trial of early in-bed cycle ergometry with ventilated patients. BMJ Open Respir Res. 2019 Feb 18;6(1):e000383. doi: 10.1136/bmjresp-2018-000383. eCollection 2019.
citation: Takaoka A, Heels-Ansdell D, Cook DJ, Kho ME. The Association between Frailty and Short-Term Outcomes in an Intensive Care Unit Rehabilitation Trial: An Exploratory Analysis. J Frailty Aging. 2021;10(1):49-55. doi: 10.14283/jfa.2020.52.
citation: Reid JC, McCaskell DS, Kho ME. Therapist perceptions of a rehabilitation research study in the intensive care unit: a trinational survey assessing barriers and facilitators to implementing the CYCLE pilot randomized clinical trial. Pilot Feasibility Stud. 2019 Nov 12;5:131. doi: 10.1186/s40814-019-0509-3. eCollection 2019.
citation: McCaskell DS, Molloy AJ, Childerhose L, Costigan FA, Reid JC, McCaughan M, Clarke F, Cook DJ, Rudkowski JC, Farley C, Karachi T, Rochwerg B, Newman A, Fox-Robichaud A, Herridge MS, Lo V, Feltracco D, Burns KE, Porteous R, Seely AJE, Ball IM, Seczek A, Kho ME. Project management lessons learned from the multicentre CYCLE pilot randomized controlled trial. Trials. 2019 Aug 28;20(1):532. doi: 10.1186/s13063-019-3634-7.
citation: Kho ME, Molloy AJ, Clarke F, Herridge MS, Koo KK, Rudkowski J, Seely AJ, Pellizzari JR, Tarride JE, Mourtzakis M, Karachi T, Cook DJ; Canadian Critical Care Trials Group. CYCLE pilot: a protocol for a pilot randomised study of early cycle ergometry versus routine physiotherapy in mechanically ventilated patients. BMJ Open. 2016 Apr 8;6(4):e011659. doi: 10.1136/bmjopen-2016-011659.