CYCLE Pilot Randomized Trial

McMaster University

Status and phase

Completed

Phase 2

Conditions

Critical Care

Respiratory Failure

Intensive Care Unit Acquired Weakness

Mechanical Ventilation

Treatments

Other: Routine physiotherapy

Device: In-bed cycle ergometer (Restorative Therapies RT300 Supine)

Study type

Interventional

Funder types

Other

Identifiers

NCT02377830

HIREB 14-531

Details and patient eligibility

About

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).

Enrollment

113 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)