E-CYCLE: A pilot randomized clinical trial of early in-bed cycling in elderly, mechanically ventilated patients

In this study all patients received treatments and had their strength tested by specially trained physiotherapists. Patients received one of two treatments: (1) in-bed cycling plus routine physiotherapy (PT) or (2) routine PT alone. Patients were assigned to either treatment in a manner similar to flipping a coin.

Research Results

Findings: Results showed that a multi-centre early in-bed cycling study in critically ill elderly patients in the intensive care unit (ICU) is feasible. A larger study is ongoing.

Impact of findings: This project is the first to study a multi-centre rehabilitation intervention in elderly critically ill. It is a crucial first step
to understanding the potential of in-bed cycling to improve the recovery of older ICU survivors in the ICU, in the hospital and after ICU discharge. This study advances our knowledge of complex, multi-disciplinary rehabilitation interventions in critically ill elderly patients. It will inform future efforts to study health outcomes in elderly patients who survive critical care.

Read more about E-CYCLE’s impact here.

About the Project

Patients in the ICU are the sickest in the hospital, and need advanced life-support. Survivors of critical illness are typically very weak and disabled. Up to one in four have severe leg weakness impairing their quality of life for as long as five years after ICU discharge. Older adults are particularly at risk of weakness, and can lose up to 4% leg strength per day due to bed rest.

In-bed cycling uses special equipment that attaches to a patient’s hospital bed, allowing them gentle leg exercise while in the ICU. The main goal of this research program was to see if patients who need a breathing machine recover faster if they receive early in-bed cycling than those who do not.

Project Team

Principal Investigator:

Michelle Kho, PT, PhD — McMaster University

Co-Investigators:

Karen Burns, MD, MSc, FRCPC — St. Michael’s Hospital

Deborah Cook, MD, MSc — McMaster University

Alison Fox-Robichaud, MD, MSc — McMaster University

Margaret Herridge, MD, MPH — University of Toronto

Timothy Karachi, MD — McMaster University

Karen Koo, MD, MSc — University of Western Ontario

Sunita Mathur, PT, PhD — University of Toronto

Marina Mourtzakis, PhD — University of Waterloo

Joseph Pellizzari, PhD, CPsych — St. Joseph’s Healthcare

Jill Rudkowski, MD — McMaster University

Andrew Seely, MD, PhD — University of Ottawa

Jean-Eric Tarride, PhD — McMaster University

Knowledge Users and Partners:

Vincent Lo, PT — Toronto General Hospital

Magda McCaughan, MSc(PT) — St. Joseph’s Healthcare

Leigh Ann Niven, MSc, MSc(PT) — Hamilton Health Sciences (Juravinski ICU)

Julie Reid, MSc, MSc(PT) — Hamilton Health Sciences (General ICU)

Project Contact: Michelle Kho — khome@mcmaster.ca

CAT 2014-06

Key words: critical illness; intensive care units; cycle ergometry; muscle; respiration; elderly

Key Findings for Families

The results of this study will help design a larger study that will measure whether in-bed cycling helps recovery after a stay in the ICU.

It was possible to enroll 25 patients in four ICUs
Patients were very willing to participate in the study (86% of those asked to participate agreed)
It is possible to do in-bed cycling the same way in different ICUs (cycling sessions were provided the same way 85% of the time)
It is possible to measure physical function to see if in-bed cycling is working in patients during and after their ICU stay (98% of all measures were collected as scheduled)

Why This Study Matters

Older adults are very likely to have weakness after an ICU stay and can lose up to 4% leg strength for every day they are in bed.
Treatments to prevent loss of strength, like in-bed cycling, could improve the recovery of older adults after they leave the ICU.

About This Study

Investigated whether it is possible for older adults who are mechanically ventilated to cycle while in bed in the ICU
Was a “pilot study”, which is a small study used to see if a larger study is feasible
Occurred in four different ICUs in Hamilton and in Toronto, Ontario
Included older adults (65+) on mechanical ventilation in the ICU who received 30 minutes per day of either in-bed cycling and usual physical therapy or usual physical therapy. The type of treatment each patient received was determined randomly (i.e. like flipping a coin)

Key Findings for Policy

It is feasible to conduct a multicenter randomized-control trial (RCT) of in-bed cycling in older mechanically ventilated adults. A future larger RCTof in-bed cycling with older mechanically ventilated adults is warranted. The findings from the larger RCT will have the potential to improve the quality and standard of care for mechanically ventilated older adults following a stay in the ICU, possibly decreasing re-hospitalization and reducing the burden on the health care system. We will also conduct an economic evaluation of the impact of in-bed cycling in critically ill older adults.

25 patients were enrolled across four sites between March 2015 and April 2016
Our consent rate was 86%, similar to or exceeding reported consent rates of most studies of rehabilitation in the ICU
Preliminary data analysis as of April 30, 2016 indicates that:
- We achieved study protocol adherence in >85% of all eligible sessions. The main reasons for patients not cycling included patient refusal and physiotherapist workload
- 98% of outcome measures were captured as scheduled
Further data analyses are ongoing

Why This Study was Needed

Survivors of the ICU often have severe leg weakness that can impair function and quality of life. Older adults are at a particularly significant risk of weakness and can lose up to 4% leg strength per day in bed, placing them at high risk of disability after hospital discharge. Cost effective interventions that prevent loss of strength and may be consistently implemented in the ICU, such as in-bed cycling, could improve the quality of life of older patients discharged from the ICU; such interventions are urgently required to improve the standard of care and long term sequelae for older adults who survive the ICU.

Study Summary

The E-CYCLE Pilot RCT was a multi-centre, pilot RCT that investigated the feasibility of providing in-bed cycling to mechanically ventilated older adults (65+) recruited from four ICUs in Hamilton and Toronto, Ontario. Patients were randomly assigned to either 30 minutes per day of in-bed cycling plus usual physical therapy or usual physical therapy. Trial feasibility data on accrual, delivery of the cycling intervention and measurement of physical function outcomes were collected.

Key Findings for Researchers

It is feasible to recruit older critically ill patients to a study of in-bed cycling in the ICU, provide cycling and measure outcomes across multiple sites. This study will inform a future larger randomized-control trial (RCT). The findings from the larger RCT will have the potential to improve the physical function and quality of life of mechanically ventilated older adults by determining the effects of in-bed cycling on outcome measures at key time points following a stay in the ICU.

25 patients were enrolled across four sites between March 2015 and April 2016
Our consent rate was 86%, similar to or exceeding reported consent rates of most studies of rehabilitation in the ICU
Preliminary data analysis as of April 30, 2016 indicates that:
- We achieved study protocol adherence in >85% of all eligible sessions. The main reasons for patients not cycling included patient refusal and physiotherapist workload
- 98% of outcome measures were captured as scheduled
Further data analyses are ongoing

Why This Study was Needed

Survivors of the ICU often have severe leg weakness that can impair their quality of life. Older adults are particularly prone to weakness and can lose up to 4% leg strength per day while in bed, leading to a high risk of disability after ICU and hospital discharge. Interventions to prevent loss of strength, such as in-bed cycling, may improve the quality of life and safety of older patients following an ICU experience.

How This Study Addresses the Gap

The E-CYCLE Pilot RCT was a multi-centre, pilot RCT that investigated the feasibility of providing in-bed cycling to mechanically ventilated older adults (65+) recruited from four ICUs in Hamilton and in Toronto, Ontario. Patients were randomly assigned to either 30 minutes per day of in-bed cycling and usual physical therapy or usual physical therapy. Trial feasibility data on accrual, delivery of the cycling intervention and measurement of physical function outcomes were collected.

Publications

Kho, M.E., Molloy, A.J., Clarke, F., Herridge, M.S., Koo, K.K.Y., Rudkowski, J., Seely, A.J.E., Pellizzari, J.R., Tarride, J.E., Mourtzakis, M., Karachi, T., Cook, D.J., Canadian Clinical 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;6: e011659. doi:10.1136/bmjopen-2016-011659.

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 K, Porteous R, Seely AJE, Ball I, Seczek A, Kho ME. Project management lessons learned from the multicentre CYCLE pilot randomized controlled trial. Trials. 2019;20(1):532.

Rationale, Hypothesis, Objectives & Research Plan

Rationale: To-date, no researchers have specifically studied early rehabilitation in the ICU in older adults. Our research will study the use of early in-bed cycling in the ICU in older adults and how it affects issues important to them (e.g., walking, quality of life). As the demand for breathing machines in Canada is expected to increase by 106% for people over 60 years between 2000 and 2026, studies like this will be helpful to reduce the impact of weakness and improve quality of life in older ICU survivors.

Hypothesis: It is feasible to enroll older adults (>= 65 years) in a multi-centre pilot randomized study of early in-bed cycling versus routine physiotherapy to inform a larger RCT.

Objectives: Study will be considered successful if the following outcomes are achieved: 1) Accrual: Following orientation, the overall average accrual rate is 3 patients per month. 2) Protocol violations: The in-bed cycling protocol can be successfully implemented with <20% protocol violations in terms of safety. 3) Outcome Measures: >80% of outcomes will be measured as scheduled. 4) Blinded Outcome Assessment: >80% of outcomes will be assessed by personnel blinded to group allocation.

Research plan: Before doing a larger study, we need to understand if 4 different ICUs can provide the same in-bed cycling very early in a patient’s ICU stay. Older adult patients (> 65 years) admitted to the ICU who need a breathing machine and are expected to survive their ICU stay are eligible. Patients will receive 1 of 2 treatments: (1) early in-bed cycling 30 minutes each day while they are in the ICU or (2) routine physiotherapy (PT).

Webinars

CFN Webinar (November 16, 2016): E-CYCLE: Clinical trial of in-bed cycling in elderly, mechanically-ventilated patients