CYCLE Pilot Randomized Trial

Respiratory Failure Clinical Trial

— CYCLE Pilot  

Official title:

CYCLE Pilot: A Pilot Randomized Study of Early Cycle Ergometry Versus Routine Physiotherapy in Mechanically Ventilated Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02377830
• Other study ID #: HIREB 14-531
• Status: Completed
• Phase: Phase 2
• Start date: March 2015
• Est. completion date: December 2018

Study information

• Verified date: November 2022
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: December 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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

Other:
• Routine physiotherapy
activities to assist with optimizing airway clearance and respiratory function, and, based on the patient's alertness and medical stability, activities to maintain or increase limb range of motion and strength, in- and out of bed mobility, and ambulation

Locations

Country	Name	City	State
Australia	Austin Health	Melbourne	Victoria
Canada	Hamilton Health Sciences General ICU	Hamilton	Ontario
Canada	Hamilton Health Sciences Juravinski ICU	Hamilton	Ontario
Canada	St. Joseph's Healthcare Intensive Care Unit	Hamilton	Ontario
Canada	London Health Sciences	London	Ontario
Canada	Ottawa General Hospital	Ottawa	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (7)

Lead Sponsor	Collaborator
McMaster University	Canadian Institutes of Health Research (CIHR), Canadian Respiratory Research Network, Hamilton Health Sciences Corporation, Ontario Lung Association, St. Joseph's Healthcare Hamilton, Technology Evaluation in the Elderly Network / Canadian Frailty Network

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Katz Activities of Daily Living Scale at ICU 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 12 and 30 days, on average, respectively
Other	Euro-QOL 5DL	5 question self-administered, preference-based instrument to measure mobility, self-care, usual activities, pain, and anxiety/ depression, as well as a global assessment of health	From study admission to approximately 12 and 30 days, on average, respectively
Primary	Patient accrual		2 years
Secondary	Cycling protocol violations (% cycling protocol violations)	% cycling protocol violations	2 years
Secondary	Outcome measure ascertainment (% outcomes measured in hospital)	% outcomes measured in hospital	2 years
Secondary	Blinded outcome measures at hospital discharge (% outcomes at hospital discharge measured by blinded outcome assessors)	% outcomes at hospital discharge measured by blinded outcome assessors	2 years
Secondary	Physical Function Test for ICU (PFIT) at ICU awakening, ICU discharge, 3-days post-ICU discharge (CYCLE Vanguard only) and hospital discharge	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	From study admission to approximately 5, 12, 15 and 30 days, on average, respectively
Secondary	Muscle strength at ICU awakening, ICU discharge, 3-days post-ICU discharge (CYCLE Vanguard only), 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, 12, 15 and 30 days, on average, respectively
Secondary	Quadriceps strength at ICU and hospital discharge (Force measured in Kg and in Newtons on a continuous scale)	The patient exerts a force against a small strain gauge that fits in the examiner's hand. .	From study admission to approximately 12 and 30 days, on average, respectively
Secondary	2 minute walk test at ICU discharge, 3-days post-ICU (CYCLE Vanguard only), and hospital discharge	Maximum distance walked in 2 minutes measured in metres on a continuous scale	From study admission to approximately 12 and 30 days, on average, respectively