Arm cycle ergometry in the ICU rehabilitation pilot study

ISRCTN	ISRCTN18074484
DOI	https://doi.org/10.1186/ISRCTN18074484
Sponsor	McMaster University
Funders	Canadian Institutes of Health Research, Research Institute of St. Joe's Hamilton

Submission date: 22/12/2025
Registration date: 31/12/2025
Last edited: 23/12/2025

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Plain English summary of protocol not provided at registration.

Contact information

Dr Michelle Kho
Principal investigator, Public, Scientific

School of Rehabilitation Science
Institute for Applied Health Sciences Building
1400 Main St W IAHS) Building - Room 403
McMaster University
Hamilton
L8S 1C7
Canada

ORCID ID	0000-0003-3170-031X
Phone	+1 2892370194
Email	khome@mcmaster.ca

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Open (masking not used)
Control	Active
Assignment	Parallel
Purpose	Treatment
Scientific title	Arm cycle ergometry in the ICU (ACE-ICU) rehabilitation pilot: a pilot randomized controlled trial of arm cycle ergometry versus routine rehabilitation in mechanically ventilated patients
Study acronym	ACE-ICU Rehabilitation Pilot RCT
Study objectives	Evaluate the feasibility of a multi-centre pilot RCT of arm cycling with MV patients: 1. Accrual - 1 to 2 patients/ month/ site 2. Protocol fidelity- >80% of study days 3. Outcome measures - >80% completed by blinded assessors at hospital discharge 4. Acceptability by patients, families, and healthcare workers
Ethics approval(s)	Approved 25/09/2025, Hamilton Integrated Research Ethics Board / Clinical Trials Ontario (237 Barton Street East, Hamilton, L8L 2X2, Canada; +1 905 521-2100 Ext: 46243; inmanma@mcmaster.ca), ref: 5333
Health condition(s) or problem(s) studied	Mechanically ventilated ICU patients who independently used their arms for functional activities (e.g., eating, dressing) before their critical illness.
Intervention	Usual ICU and Ward rehabilitation – Patients will receive routine rehabilitation (e.g., interventions from physiotherapists and occupational therapists) per current institutional practice. Routine physiotherapy includes activities to optimize airway clearance and respiratory function, and, 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, and ambulation. Routine occupational therapy includes joint contracture prevention (e.g., splinting), equipment provision (e.g., wheelchairs), pressure injury prevention and treatment, and activities to help patients return to their roles in life (e.g., bathing, dressing). Intervention description - Patients will be randomized to receive 10 minutes of arm cycling in addition to Usual ICU and ward rehabilitation, 5 days per week, for the duration of their ICU and hospital stay (to a maximum of 28 days). We will use a specialized arm cycle (e.g., RT300 supine cycle modified with arm attachments), which provides 3 possible cycling modes: passive (i.e., no patient initiation), active-assisted (i.e., partially patient-initiated), or active (i.e., fully patient-initiated).A patient’s ability to perform arm cycling is not a requirement to join the trial because the ergometer can accommodate passive and active cycling. We aim for participants to complete as much active cycling as possible during each session for a target of 10 minutes, based on pilot data and our systematic review. The therapist will place the participants’ arms in the cycle ergometer, starting with passive cycling at 5 revolutions per minute (RPM) with no resistance. If patients initiate active cycling, the therapist will use standardized encouragement to promote active participation and muscle activation. Since ICU patients’ level of consciousness may vary throughout their stay, we will allow patients to cycle at a self-selected RPM. If the patients stop cycling actively, the ergometer will revert to passive cycling. If patients restart active cycling, we will provide standardized encouragement as above.
Intervention type	Device
Phase	Phase II
Drug / device / biological / vaccine name(s)	Arm cycle ergometer
Primary outcome measure(s)	Accrual (1-2 patients per month per site) measured using study data collection at the end of the study Protocol fidelity (>80 % of study days) measured using study data collection at End of study
Key secondary outcome measure(s)	Lower body strength and endurance measured using the number of repetitions in 30 seconds in the 30-second sit-to-stand test at ICU awakening, ICU discharge, hospital discharge (by assessors blinded to treatment group) Global muscle strength measured using the Medical Research Council Sum Score standardized assessor rating of static strength in 6 muscle groups at ICU awakening, ICU discharge, hospital discharge (by assessors blinded to treatment group) Hand grip strength measured using a hand grip dynamometer (kg) at ICU awakening, ICU discharge, hospital discharge (by assessors blinded to treatment group) Physical function measured using the Physical Function ICU Test score out of 10 (higher scores, better function) at ICU awakening, ICU discharge, hospital discharge (by assessors blinded to treatment group) Patient-centered function measured using the Patient-Specific Functional Scale (PSFS) for the ICU score out of 10 (higher scores, better function) at ICU discharge, hospital discharge Quality of Life measured using the Euro-QoL 5D-5L at ICU Discharge, Hospital Discharge, 90-days post-randomization Anxiety and depression measured using the Hospital Anxiety and Depression Scale at 90-days post-randomization
Completion date	15/10/2028

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	100 Years
Sex	All
Target sample size at registration	60
Key inclusion criteria	1. Adults (>= 18 years old) 2. Who used their upper limbs for functional activities (e.g., dressing, bathing) before their critical illness 3. Within the first 7 days of their ICU stay 4. Received or are receiving mechanical ventilation (invasive or non-invasive) for >24 hours 5. Within the first 4 days of starting mechanical ventilation
Key exclusion criteria	1. Known shoulder pathology 2. Impaired shoulder range of motion 3. Any condition impairing patients’ ability to cycle (e.g., arm fracture) 4. Proven or suspected neuromuscular weakness affecting the arms 5. Unable to follow commands pre-critical illness 6. Expected hospital mortality >90% 7. Body habitus unable to fit the bike, palliative goals of care 8. Persistent therapy exemptions in the first 4 days of ICU stay (e.g., cardiorespiratory instability, active major bleeding)
Date of first enrolment	15/04/2026
Date of final enrolment	15/04/2028

Locations

Countries of recruitment

Australia
Canada

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan

Editorial Notes

23/12/2025: Study’s existence confirmed by the Hamilton Integrated Research Ethics Board (HIREB)/ Clinical Trials Ontario, Canada.