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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
NA
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
15/10/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2024
Actual
Sample size
Target
360
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.


Results not provided in https://clinicaltrials.gov/study/NCT03471247