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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03471247
Ethics application status
Date submitted
7/03/2018
Date registered
20/03/2018

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)
Timepoint [1] 0 0
3 days after ICU discharge
Secondary outcome [1] 0 0
Physical Function Test for ICU-scored (PFIT-s)
Timepoint [1] 0 0
ICU Awakening, approximately 6 days after ICU admission; ICU Discharge, approximately 12 days after ICU admission; Hospital Discharge, approximately 28 days after ICU admission
Secondary outcome [2] 0 0
Muscle 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
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
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)
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
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
Timepoint [7] 0 0
Baseline; hospital discharge, approximately 28 days after ICU admission
Secondary outcome [8] 0 0
Intensive Care Psychological Assessment Tool (IPAT)
Timepoint [8] 0 0
After ICU awakening assessment, approximately 7 days after ICU admission
Secondary outcome [9] 0 0
Duration of Mechanical Ventilation
Timepoint [9] 0 0
From study admission to ICU discharge, approximately 10 days
Secondary outcome [10] 0 0
Length of stay
Timepoint [10] 0 0
From hospital admission to ICU discharge (approximately 14 days) and hospital discharge (approximately 21 days)
Secondary outcome [11] 0 0
Health-Related Quality of Life - EuroQol-5D-5L and Visual Analogue Scale
Timepoint [11] 0 0
ICU discharge, approximately 12 days after ICU admission; hospital discharge, approximately 28 days after ICU admission; 3 months after enrollment
Secondary outcome [12] 0 0
Mortality
Timepoint [12] 0 0
From study admission to 3 months after enrollment
Secondary outcome [13] 0 0
Hospital Discharge Location
Timepoint [13] 0 0
Hospital discharge, approximately 28 days after ICU admission
Secondary outcome [14] 0 0
Hospital Anxiety and Depression Scale (HADS)
Timepoint [14] 0 0
3 months after enrollment
Secondary outcome [15] 0 0
Quality-Adjusted Life Years (QALYs)
Timepoint [15] 0 0
3 months after enrollment
Secondary outcome [16] 0 0
Healthcare Utilization
Timepoint [16] 0 0
From study admission to 3 months after enrollment
Secondary outcome [17] 0 0
Intervention and Healthcare Costs
Timepoint [17] 0 0
From study admission to 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) before their critical illness
* ICU length of stay = 7 days
Minimum age
18 Years
Maximum age
No limit
Sex
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
* Severe cognitive impairment pre-ICU
* Traumatic brain injury
* Acute proven or suspected central or peripheral neuromuscular weakness affecting the legs (e.g., stroke, Guillian-Barre syndrome, spinal injury)
* Temporary pacemaker (internal or external)
* Expected hospital mortality = 90%
* Equipment unable to fit patient's body dimensions (elg., leg amputation, morbid obesity)
* Palliative goals of care
* Pregnancy (suspected or proven)
* 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
Active, not 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
Government body
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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

TypeOther DetailsAttachment
Statistical analysis plan https://cdn.clinicaltrials.gov/large-docs/47/NCT03471247/SAP_000.pdf



Results publications and other study-related documents

No documents have been uploaded by study researchers.