About this trial
This single-blind, three-group parallel randomized controlled trial will involve 138 patients with critical illness, randomly assigned at a 1:1:1 ratio to the technology-assisted early mobilization group (46 patients), the systematic early mobilization group (46 patients), or the control group (46 patients). The technology-assisted early mobilization group will receive interventions within 72 hours of ventilator use. The interventions include protocol-oriented early mobilization program carried out by physiotherapist and researcher and technology-assisted in-bed activities primarily assisted by family members. The systematic early mobilization group will receive only the similar protocol-oriented early mobilization program within 72 hours of ventilator use. The control group will receive routine rehabilitation as usual. The primary outcomes include occurrence of intensive care unit-acquired weakness (ICUAW). Secondary outcomes include muscle strength, delirium, sleep status, clinical outcomes, activities of daily living, and quality of life. Measurements will be assessed on the day of enrollment, during the ICU stay, on the day of ICU discharge (or up to 28 days), on the day of hospital discharge, and six months after hospital discharge.
Eligibility criteria
Qualifiers
Aged ≥ 18 years
Being mechanically ventilated ≥ 24 hours
Richmond Agitation-Sedation Scale (RASS): 0 to -1
No vision, hearing, or body movements restriction
Disqualifiers
Have developed delirium before enrollment (ICDSC > 4)
With acute physiology and chronic health evaluation (APACHE II) score > 25 after ICU admission within 24 hours
With muscle weakness caused by severe acute brain injury (e.g., traumatic brain injury or stroke), spinal coral injury, other neuromuscular conduction diseases, or long-term bedridden or hemiplegia.
Trial design
Treatments tested in this trial
- Technology-assisted, family-engaged in-bed activities
- Protocol-oriented early mobilization program
Treatment groups
Sponsors and collaborators
Hsiao-Yean Chiu
Lead sponsor
Taipei Medical University
Sponsor institution
Taipei Medical University Hospital
Collaborator
National Science and Technology Council, Taiwan
Collaborator