CYCLE Pilot Randomized Trial

Phase 2

Completed

• Conditions: Mechanical Ventilation; Critical Care; Respiratory Failure; Intensive Care Unit Acquired Weakness
• Interventions: Device: In-bed cycle ergometer (Restorative Therapies RT300 Supine); Other: Routine physiotherapy

• Registration Number: NCT02377830
• Lead Sponsor: McMaster University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-26
• Study Start: 2015-03
• Study First Submitted QC: 2015-03-03
• Study First Posted: 2015-03-04
• Primary Completion: 2018-03
• Study Completion: 2018-12
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-30
• Last Update Posted: 2022-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Cycling and routine physiotherapy	In-bed cycle ergometer (Restorative Therapies RT300 Supine)	Patients will receive 30 minutes of in-bed cycling in addition to routine physiotherapy, 5 days per week, for the duration of their ICU stay
Routine physiotherapy	Routine physiotherapy	Patients will receive routine physiotherapy per current institutional practice

Primary Outcome Measures

Name	Time	Method
Patient accrual	2 years

Secondary Outcome Measures

Name	Time	Method
Outcome measure ascertainment (% outcomes measured in hospital)	2 years	% outcomes measured in hospital
Muscle strength at ICU awakening, ICU discharge, 3-days post-ICU discharge (CYCLE Vanguard only), and hospital discharge	From study admission to approximately 5, 12, 15 and 30 days, on average, respectively	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).
Cycling protocol violations (% cycling protocol violations)	2 years	% cycling protocol violations
Quadriceps strength at ICU and hospital discharge (Force measured in Kg and in Newtons on a continuous scale)	From study admission to approximately 12 and 30 days, on average, respectively	The patient exerts a force against a small strain gauge that fits in the examiner's hand. .
Blinded outcome measures at hospital discharge (% outcomes at hospital discharge measured by blinded outcome assessors)	2 years	% outcomes at hospital discharge measured by blinded outcome assessors
Physical Function Test for ICU (PFIT) at ICU awakening, ICU discharge, 3-days post-ICU discharge (CYCLE Vanguard only) and hospital discharge	From study admission to approximately 5, 12, 15 and 30 days, on average, respectively	Patients complete 4 activities: arm and leg strength, ability to stand, and step cadence. Scores range from 0 to 10, with higher scores = better function
2 minute walk test at ICU discharge, 3-days post-ICU (CYCLE Vanguard only), and hospital discharge	From study admission to approximately 12 and 30 days, on average, respectively	Maximum distance walked in 2 minutes measured in metres on a continuous scale

Trial Locations

Locations (9)

Austin Health; 🇦🇺 Melbourne, Victoria, Australia

Hamilton Health Sciences Juravinski ICU; 🇨🇦 Hamilton, Ontario, Canada

Hamilton Health Sciences General ICU; 🇨🇦 Hamilton, Ontario, Canada

St. Joseph's Healthcare Intensive Care Unit; 🇨🇦 Hamilton, Ontario, Canada

London Health Sciences; 🇨🇦 London, Ontario, Canada

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada

Ottawa General Hospital; 🇨🇦 Ottawa, Ontario, Canada

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States