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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03471247




Registration number
NCT03471247
Ethics application status
Date submitted
7/03/2018
Date registered
20/03/2018
Date last updated
26/09/2019

Titles & IDs
Public title
CYCLE: A Randomized Clinical Trial of Early In-bed Cycling for Mechanically Ventilated Patients
Scientific title
CYCLE RCT: An International, Multi-centre, Randomized Clinical Trial of Early In-bed Cycling for Mechanically Ventilated Patients
Secondary ID [1] 0 0
CYCLE RCT
Universal Trial Number (UTN)
Trial acronym
CYCLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intensive Care Unit Acquired Weakness 0 0
Critical Care 0 0
Mechanical Ventilation 0 0
Respiratory Failure 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - In-Bed Cycle Ergometer
Other interventions - Routine PT

Experimental: In-Bed Cycle Ergometer + Routine PT - Patients will receive 30 minutes of in-bed cycling once per day, 5 days per week, while they remain in the ICU, for up to a maximum of 28 days. They will also receive routine physiotherapy.

Active Comparator: Routine PT - Patients will receive routine physiotherapy interventions per current institutional practice


Treatment: Devices: In-Bed Cycle Ergometer
Physiotherapists will place the patient's legs in a specialized in-bed cycle ergometer allowing for gentle leg exercise. Exercise can performed in passive, active-assisted, or active mode.

Other interventions: Routine PT
Includes, 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, ambulation, and assistance with optimizing airway clearance and respiratory function.

Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Physical Function Test for ICU-scored (PFIT-s) - 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.
Timepoint [1] 0 0
3 days after ICU discharge
Secondary outcome [1] 0 0
Physical Function Test for ICU-scored (PFIT-s) - 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.
Timepoint [1] 0 0
ICU Awakening, approximately 6 days after ICU admission; ICU Discharge, approximately 12 days after ICU admission; 3 days after ICU discharge; Hospital Discharge, approximately 28 days after ICU admission
Secondary outcome [2] 0 0
Muscle Strength - 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 scale (0 = no contraction, 5 = contraction sustained against maximal resistance). Scores range from 0 to 60, with higher scores = better strength.
Timepoint [2] 0 0
ICU Awakening, approximately 6 days after ICU admission; ICU Discharge, approximately 12 days after ICU admission; 3 days after ICU discharge; Hospital Discharge, approximately 28 days after ICU admission
Secondary outcome [3] 0 0
30 Second Sit to Stand - Patient completes as many sit to stand repetitions as possible in 30 seconds. Total number of repetitions is recorded as patient's score. Higher repetitions represent better function.
Timepoint [3] 0 0
ICU Awakening, approximately 6 days after ICU admission; ICU Discharge, approximately 12 days after ICU admission; 3 days after ICU discharge; Hospital Discharge, approximately 28 days after ICU admission
Secondary outcome [4] 0 0
Two Minute Walk Test - Maximum distance walked in 2 minutes measured in metres on a continuous scale.
Timepoint [4] 0 0
ICU Discharge, approximately 12 days after ICU admission; 3 days after ICU discharge; Hospital Discharge, approximately 28 days after ICU admission
Secondary outcome [5] 0 0
Patient-Reported Functional Scale-ICU (PRFS-ICU) - Assesses patient's perception of their physical function. Patients rate their ability to perform 6 mobility activities on a 0-10 scale (0=unable to perform activity, 10=able to perform activity at same level as before ICU admission). Scores range from 0 to 60, with higher scores representing better function.
Timepoint [5] 0 0
ICU discharge, approximately 12 days after ICU admission; hospital discharge, approximately 28 days after ICU admission; 3 months after enrollment
Secondary outcome [6] 0 0
Katz Activities of Daily Living (ADL) Scale - Rates 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. Scores range from 0 to 6, with higher scores representing better function.
Timepoint [6] 0 0
Baseline; ICU discharge, approximately 12 days after ICU admission; hospital discharge, approximately 28 days after ICU admission
Secondary outcome [7] 0 0
Clinical Frailty Scale - Patients are ranked on a scale from 1-9 according to level of frailty based on clinical descriptions (1 = very fit, 9 = terminally ill).
Timepoint [7] 0 0
Baseline; hospital discharge, approximately 28 days after ICU admission
Secondary outcome [8] 0 0
Intensive Care Psychological Assessment Tool (IPAT) - Patients answer 10 questions related to critical care-related psychological distress. Scores range from 0-20, with scores of 7 or greater indicating a patient at risk of future psychological morbidity.
Timepoint [8] 0 0
After ICU awakening assessment, approximately 7 days after ICU admission
Secondary outcome [9] 0 0
Health-Related Quality of Life - EuroQol-5D-5L - Five question self-administered, preference-based instrument to measure mobility, self-care, usual activities, pain, and anxiety/depression, as well as a visual analogue scale (VAS) global assessment of health. For each dimension, the participant chooses 1 of 5 levels that best describes their health on that day: "no problem" (1), "slight" (2), "moderate" (3), "severe" (4), or "unable/extreme" (5). The VAS is the participant's rating of their health on a scale of 0 "worst health you can imagine" to 100 "best health you can imagine".
Timepoint [9] 0 0
ICU discharge, approximately 12 days after ICU admission; hospital discharge, approximately 28 days after ICU admission; 3 months after enrollment
Secondary outcome [10] 0 0
Quality-Adjusted Life Years (QALYs) - A measure of health outcomes for economic evaluation that incorporates the impact of an intervention on both the quantity and quality of life.
Timepoint [10] 0 0
3 months after enrollment
Secondary outcome [11] 0 0
Mortality - Death in ICU, hospital, or post-discharge.
Timepoint [11] 0 0
From study admission to 3 months after enrollment
Secondary outcome [12] 0 0
Hospital Discharge Location - For survivors: home, inpatient rehabilitation, other hospital, chronic care, assisted living facility, nursing home.
Timepoint [12] 0 0
Hospital discharge, approximately 28 days after ICU admission
Secondary outcome [13] 0 0
Healthcare Utilization - Includes emergency room visits and hospitalizations, family doctor visits, specialist visits and outpatient clinics, other healthcare professional services.
Timepoint [13] 0 0
From study admission to 3 months after enrollment
Secondary outcome [14] 0 0
Intervention and Healthcare Costs - Includes emergency room visits and hospitalizations, family doctor visits, specialist visits and outpatient clinics, assistive devices, renovations and modifications, other healthcare professional services, employment status and time off work, assistance from others.
Timepoint [14] 0 0
From study admission to 3 months after enrollment
Secondary outcome [15] 0 0
Hospital Anxiety and Depression Scale (HADS) - Patient answers 14 questions related to anxiety and depression. Scores range from 0-21 with higher score indicating more distress.
Timepoint [15] 0 0
3 months after enrollment

Eligibility
Key inclusion criteria
- Patient is = 18 years of age

- Patient is invasively mechanically ventilated = 4 days

- Expected additional 2 day ICU stay

- Ability to ambulate independently (with or without gait aid) pre-hospital

- ICU length of stay = 7 days
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pre-hospital inability to follow simple commands in local language at baseline

- Acute conditions impairing ability to receive cycling

- Acute proven or suspected central or peripheral neuromuscular weakness

- Temporary pacemaker (internal or external)

- Expected hospital mortality = 90%

- Equipment unable to fit patient's body dimensions

- Palliative goals of care

- Pregnancy

- Specific surgical exclusion as stipulated by surgery or ICU team

- Physician declines

- Cycling exemption not resolved during first 4 days of mechanical ventilation

- Patient already able to march on spot at time of screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Maryland
Country [2] 0 0
United States of America
State/province [2] 0 0
North Carolina
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Other
Name
McMaster University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
St. Joseph's Healthcare Hamilton
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Canadian Institutes of Health Research (CIHR)
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Canadian Critical Care Trials Group
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Patients who survive critical illness usually experience long-lasting physical and
psychological impairments, which are often debilitating. Rehabilitation interventions started
in the ICU may reduce this morbidity. In-bed cycling, which uses a special bicycle that
attaches to the hospital bed, allows critically ill patients who are mechanically ventilated
(MV) to gently exercise their legs while in the ICU. The main goal of this study is to
determine whether critically ill MV adults recover faster if they receive early in-bed
cycling than if they do not. Another objective is to determine whether in-bed cycling is a
cost-effective intervention. 360 patients admitted to the ICU and receiving MV will be
enrolled in the study. Following informed consent, patients will be randomized to either (1)
early in-bed cycling and routine physiotherapy or (2) routine physiotherapy alone. Patients'
strength and physical function will be measured throughout the study. If early in-bed cycling
during critical illness improves short-term physical and functional outcomes, it could
accelerate recovery and reduce long-term disability in ICU survivors.
Trial website
https://clinicaltrials.gov/show/NCT03471247
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michelle Kho, PT, PhD
Address 0 0
McMaster University School of Rehabilitation Science
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Michelle Kho, PT, PhD
Address 0 0
Country 0 0
Phone 0 0
905-525-9140
Fax 0 0
Email 0 0
khome@mcmaster.ca
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03471247