CYCLE: A Randomized Clinical Trial of Early In-bed Cycling for Mechanically Ventilated Patients (CYCLE)
Primary Purpose
Intensive Care Unit Acquired Weakness, Critical Care, Mechanical Ventilation
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
In-Bed Cycle Ergometer
Routine PT
Sponsored by
About this trial
This is an interventional treatment trial for Intensive Care Unit Acquired Weakness
Eligibility Criteria
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
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
Sites / Locations
- University of Maryland Medical Centre
- Duke University Hospital
- Austin Health - Austin Hospital
- Brant Community Healthcare System - Brantford General Hospital
- Hamilton Health Sciences - Hamilton General Hospital
- St. Joseph's Healthcare Hamilton
- Hamilton Health Sciences - Juravinski Hospital
- Kingston Health Sciences Centre - Kingston General Hospital
- London Health Sciences Centre - Victoria Hospital
- The Ottawa Hospital - General Campus
- The Ottawa Hospital - Civic Campus
- Niagara Health System - St. Catharines Site
- St. Michael's Hospital
- Centre Integre de Sante et de Services Sociaux de Chaudiere-Appalaches - Hotel-Dieu de Levis
- Centre Integre Universitaire de Sante et de Services Sociaux du Nord-de-L'Ile-de-Montreal - Hopital du Sacre-Coeur de Montreal
- Centre Integre Universitaire de Sante et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
In-Bed Cycle Ergometer + Routine PT
Routine PT
Arm Description
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.
Patients will receive routine physiotherapy interventions per current institutional practice
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Two Minute Walk Test
Maximum distance walked in 2 minutes measured in metres on a continuous scale.
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.
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.
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).
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.
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".
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.
Mortality
Death in ICU, hospital, or post-discharge.
Hospital Discharge Location
For survivors: home, inpatient rehabilitation, other hospital, chronic care, assisted living facility, nursing home.
Healthcare Utilization
Includes emergency room visits and hospitalizations, family doctor visits, specialist visits and outpatient clinics, other healthcare professional services.
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.
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.
Full Information
NCT ID
NCT03471247
First Posted
March 7, 2018
Last Updated
May 17, 2023
Sponsor
McMaster University
Collaborators
St. Joseph's Healthcare Hamilton, Canadian Institutes of Health Research (CIHR), Canadian Critical Care Trials Group
1. Study Identification
Unique Protocol Identification Number
NCT03471247
Brief Title
CYCLE: A Randomized Clinical Trial of Early In-bed Cycling for Mechanically Ventilated Patients
Acronym
CYCLE
Official Title
CYCLE RCT: An International, Multi-centre, Randomized Clinical Trial of Early In-bed Cycling for Mechanically Ventilated Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
St. Joseph's Healthcare Hamilton, Canadian Institutes of Health Research (CIHR), Canadian Critical Care Trials Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Background: Survivors of critical illness have a long road of physical, cognitive, and psychological recovery. Although medical advances have reduced the mortality of critical illness, survival often comes with substantial long-term morbidity and societal cost. At 1-year follow-up, ~35% of intensive care unit (ICU) survivors had sub-normal 6-minute walk distance, and ~50% had not returned to work. Rehabilitation interventions started in the ICU may reduce this morbidity. In-bed cycling is a novel technology that may help critically ill, mechanically ventilated (MV) patients receive exercise very early to prevent or attenuate muscle weakness. Patients on MV typically receive prolonged bedrest and are often perceived as 'too sick' for physiotherapy (PT) interventions. However expert consensus and our previous multicentre pilot work suggest these interventions are safe. The CYCLE RCT will evaluate whether early in-bed cycling compared to usual PT interventions improves patient-reported outcomes.
Objectives:
CYCLE RCT: To determine if early in-bed cycling and routine PT compared to routine PT alone in critically ill, mechanically ventilated adults improves the primary outcome of physical function at 3 days after ICU discharge and secondary outcomes of strength, physical function, frailty, psychological distress, quality of life, mortality, and healthcare utilization.
Economic Evaluation: To determine the cost-effectiveness of cycling and routine PT compared to routine PT alone among critically ill, mechanically ventilated adults.
Design: 360-patient concealed open-label RCT with blinded outcome assessment
Population: Critically ill adults receiving MV in a medical-surgical ICU
Methods: After informed consent, patients will be randomized to receive 30 minutes/day of cycling, 5 days per week and routine PT interventions or routine PT interventions alone. Assessors, blinded to treatment allocation, will measure the primary outcome of patients' physical function at 3 days post-ICU. Secondary outcomes will be measured at ICU awakening, ICU discharge, 3 days post-ICU, hospital discharge, and 90-days post-enrollment.
Relevance: By 2026, demand for ICU services is estimated to increase by 40% and more survivors will be at risk for post-ICU disability. If early cycling during critical illness improves short-term physical and functional outcomes, it could accelerate recovery and reduce long-term disability in ICU survivors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intensive Care Unit Acquired Weakness, Critical Care, Mechanical Ventilation, Respiratory Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
In-Bed Cycle Ergometer + Routine PT
Arm Type
Experimental
Arm Description
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.
Arm Title
Routine PT
Arm Type
Active Comparator
Arm Description
Patients will receive routine physiotherapy interventions per current institutional practice
Intervention Type
Device
Intervention Name(s)
In-Bed Cycle Ergometer
Other Intervention Name(s)
Restorative Therapies RT300 Supine
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Routine PT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physical Function Test for ICU-scored (PFIT-s)
Description
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.
Time Frame
3 days after ICU discharge
Secondary Outcome Measure Information:
Title
Physical Function Test for ICU-scored (PFIT-s)
Description
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.
Time Frame
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
Title
Muscle Strength
Description
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.
Time Frame
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
Title
30 Second Sit to Stand
Description
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.
Time Frame
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
Title
Two Minute Walk Test
Description
Maximum distance walked in 2 minutes measured in metres on a continuous scale.
Time Frame
ICU Discharge, approximately 12 days after ICU admission; 3 days after ICU discharge; Hospital Discharge, approximately 28 days after ICU admission
Title
Patient-Reported Functional Scale-ICU (PRFS-ICU)
Description
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.
Time Frame
ICU discharge, approximately 12 days after ICU admission; hospital discharge, approximately 28 days after ICU admission; 3 months after enrollment
Title
Katz Activities of Daily Living (ADL) Scale
Description
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.
Time Frame
Baseline; ICU discharge, approximately 12 days after ICU admission; hospital discharge, approximately 28 days after ICU admission
Title
Clinical Frailty Scale
Description
Patients are ranked on a scale from 1-9 according to level of frailty based on clinical descriptions (1 = very fit, 9 = terminally ill).
Time Frame
Baseline; hospital discharge, approximately 28 days after ICU admission
Title
Intensive Care Psychological Assessment Tool (IPAT)
Description
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.
Time Frame
After ICU awakening assessment, approximately 7 days after ICU admission
Title
Health-Related Quality of Life - EuroQol-5D-5L
Description
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".
Time Frame
ICU discharge, approximately 12 days after ICU admission; hospital discharge, approximately 28 days after ICU admission; 3 months after enrollment
Title
Quality-Adjusted Life Years (QALYs)
Description
A measure of health outcomes for economic evaluation that incorporates the impact of an intervention on both the quantity and quality of life.
Time Frame
3 months after enrollment
Title
Mortality
Description
Death in ICU, hospital, or post-discharge.
Time Frame
From study admission to 3 months after enrollment
Title
Hospital Discharge Location
Description
For survivors: home, inpatient rehabilitation, other hospital, chronic care, assisted living facility, nursing home.
Time Frame
Hospital discharge, approximately 28 days after ICU admission
Title
Healthcare Utilization
Description
Includes emergency room visits and hospitalizations, family doctor visits, specialist visits and outpatient clinics, other healthcare professional services.
Time Frame
From study admission to 3 months after enrollment
Title
Intervention and Healthcare Costs
Description
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.
Time Frame
From study admission to 3 months after enrollment
Title
Hospital Anxiety and Depression Scale (HADS)
Description
Patient answers 14 questions related to anxiety and depression. Scores range from 0-21 with higher score indicating more distress.
Time Frame
3 months after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Kho, PT, PhD
Organizational Affiliation
McMaster University School of Rehabilitation Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland Medical Centre
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Austin Health - Austin Hospital
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Brant Community Healthcare System - Brantford General Hospital
City
Brantford
State/Province
Ontario
ZIP/Postal Code
N3R 1G9
Country
Canada
Facility Name
Hamilton Health Sciences - Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Hamilton Health Sciences - Juravinski Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Facility Name
Kingston Health Sciences Centre - Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
London Health Sciences Centre - Victoria Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
The Ottawa Hospital - General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
The Ottawa Hospital - Civic Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
Niagara Health System - St. Catharines Site
City
St. Catharines
State/Province
Ontario
ZIP/Postal Code
L2S 0A9
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Centre Integre de Sante et de Services Sociaux de Chaudiere-Appalaches - Hotel-Dieu de Levis
City
Lévis
State/Province
Quebec
ZIP/Postal Code
G6V 3Z1
Country
Canada
Facility Name
Centre Integre Universitaire de Sante et de Services Sociaux du Nord-de-L'Ile-de-Montreal - Hopital du Sacre-Coeur de Montreal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Centre Integre Universitaire de Sante et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36056378
Citation
Reid JC, Molloy A, Strong G, Kelly L, O'Grady H, Cook D, Archambault PM, Ball I, Berney S, Burns KEA, D'Aragon F, Duan E, English SW, Lamontagne F, Pastva AM, Rochwerg B, Seely AJE, Serri K, Tsang JLY, Verceles AC, Reeve B, Fox-Robichaud A, Muscedere J, Herridge M, Thabane L, Kho ME; CYCLE Investigators. Research interrupted: applying the CONSERVE 2021 Statement to a randomized trial of rehabilitation during critical illness affected by the COVID-19 pandemic. Trials. 2022 Sep 2;23(1):735. doi: 10.1186/s13063-022-06640-y.
Results Reference
background
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CYCLE: A Randomized Clinical Trial of Early In-bed Cycling for Mechanically Ventilated Patients
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