Respiratory Failure Clinical Trial
— CYCLEOfficial title:
CYCLE RCT: An International, Multi-centre, Randomized Clinical Trial of Early In-bed Cycling for Mechanically Ventilated Patients
Verified date | May 2024 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 360 |
Est. completion date | August 2024 |
Est. primary completion date | May 26, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Austin Health - Austin Hospital | Heidelberg | Victoria |
Canada | Brant Community Healthcare System - Brantford General Hospital | Brantford | Ontario |
Canada | Hamilton Health Sciences - Hamilton General Hospital | Hamilton | Ontario |
Canada | Hamilton Health Sciences - Juravinski Hospital | Hamilton | Ontario |
Canada | St. Joseph's Healthcare Hamilton | Hamilton | Ontario |
Canada | Kingston Health Sciences Centre - Kingston General Hospital | Kingston | Ontario |
Canada | Centre Integre de Sante et de Services Sociaux de Chaudiere-Appalaches - Hotel-Dieu de Levis | Lévis | Quebec |
Canada | London Health Sciences Centre - Victoria Hospital | London | Ontario |
Canada | Centre Integre Universitaire de Sante et de Services Sociaux du Nord-de-L'Ile-de-Montreal - Hopital du Sacre-Coeur de Montreal | Montréal | Quebec |
Canada | The Ottawa Hospital - Civic Campus | Ottawa | Ontario |
Canada | The Ottawa Hospital - General Campus | Ottawa | Ontario |
Canada | Centre Integre Universitaire de Sante et de services sociaux de l'Estrie - Centre hospitalier universitaire de Sherbrooke | Sherbrooke | Quebec |
Canada | Niagara Health System - St. Catharines Site | St. Catharines | Ontario |
Canada | St. Michael's Hospital | Toronto | Ontario |
United States | University of Maryland Medical Centre | Baltimore | Maryland |
United States | Duke University Hospital | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
McMaster University | Canadian Critical Care Trials Group, Canadian Institutes of Health Research (CIHR), St. Joseph's Healthcare Hamilton |
United States, Australia, Canada,
Kho ME, Reid J, Molloy AJ, Herridge MS, Seely AJ, Rudkowski JC, Buckingham L, Heels-Ansdell D, Karachi T, Fox-Robichaud A, Ball IM, Burns KEA, Pellizzari JR, Farley C, Berney S, Pastva AM, Rochwerg B, D'Aragon F, Lamontagne F, Duan EH, Tsang JLY, Archambault P, English SW, Muscedere J, Serri K, Tarride JE, Mehta S, Verceles AC, Reeve B, O'Grady H, Kelly L, Strong G, Hurd AH, Thabane L, Cook DJ; CYCLE Investigators and the Canadian Critical Care Trials Group. Critical Care Cycling to Improve Lower Extremity Strength (CYCLE): protocol for an international, multicentre randomised clinical trial of early in-bed cycling for mechanically ventilated patients. BMJ Open. 2023 Jun 23;13(6):e075685. doi: 10.1136/bmjopen-2023-075685. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 3 days after ICU discharge | |
Secondary | 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. | 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 | 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. | 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 | 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. | 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 | Two Minute Walk Test | Maximum distance walked in 2 minutes measured in metres on a continuous scale. | ICU Discharge, approximately 12 days after ICU admission; 3 days after ICU discharge; Hospital Discharge, approximately 28 days after ICU admission | |
Secondary | 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. | ICU discharge, approximately 12 days after ICU admission; hospital discharge, approximately 28 days after ICU admission; 3 months after enrollment | |
Secondary | 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. | Baseline; ICU discharge, approximately 12 days after ICU admission; hospital discharge, approximately 28 days after ICU admission | |
Secondary | 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). | Baseline; hospital discharge, approximately 28 days after ICU admission | |
Secondary | 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. | After ICU awakening assessment, approximately 7 days after ICU admission | |
Secondary | Duration of Mechanical Ventilation | Duration of invasive mechanical ventilation | From study admission to ICU discharge, approximately 10 days | |
Secondary | Length of stay | ICU and Hospital length of stay | From hospital admission to ICU discharge (approximately 14 days) and hospital discharge (approximately 21 days) | |
Secondary | Health-Related Quality of Life - EuroQol-5D-5L and Visual Analogue Scale | 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". | ICU discharge, approximately 12 days after ICU admission; hospital discharge, approximately 28 days after ICU admission; 3 months after enrollment | |
Secondary | Mortality | Death in ICU, hospital, or post-discharge. | From study admission to 3 months after enrollment | |
Secondary | Hospital Discharge Location | For survivors: home, inpatient rehabilitation, other hospital, chronic care, assisted living facility, nursing home. | Hospital discharge, approximately 28 days after ICU admission | |
Secondary | 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. | 3 months after enrollment | |
Secondary | 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. | 3 months after enrollment | |
Secondary | Healthcare Utilization | Includes emergency room visits and hospitalizations, family doctor visits, specialist visits and outpatient clinics, other healthcare professional services. | From study admission to 3 months after enrollment | |
Secondary | 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. | From study admission to 3 months after enrollment |
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