Clinical trial NCT06700694: Technology-Assisted Early Mobilization Program Among Patients in the Intensive Care Units
Official title: The Effect of Technology-Assisted Early Mobilization Program Among Patients in the Intensive Care Units: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intensive Care Unit Acquired Weakness
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
Collaborators: name: Taipei Medical University Hospital
name: National Science and Technology Council, Taiwan
First posted: 2024-11-22
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: Inclusion Criteria:

* Aged ≥ 18 years
* Being mechanically ventilated ≥ 24 hours
* Richmond Agitation-Sedation Scale (RASS): 0 to -1
* No vision, hearing, or body movements restriction
* With clear consciousness and ability to communicate in Chinese
* Expected to stay in the ICU \> 96 hours.

Exclusion Criteria:

* Being pregnant, menopausal, or having a night shift within one month before admission to the ICU
* 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.

Primary outcomes:
measure: Occurrence of intensive care unit-acquired weakness (ICUAW)
timeFrame: On the day of enrollment and ICU discharge (or up to 28 days after enrollment).
Secondary outcomes:
measure: Muscle power
timeFrame: On the day of enrollment and ICU discharge (or up to 28 days after enrollment).
measure: Hand-grip strength
timeFrame: On the day of enrollment and ICU discharge (or up to 28 days after enrollment).
measure: Delirium
timeFrame: Through intervention completion, up to 28 days.
measure: Subjective sleep status
timeFrame: Through intervention completion, up to 28 days.
measure: Objective sleep status
timeFrame: Through intervention completion, up to 28 days.
measure: Functional Status
timeFrame: On the day of enrollment and ICU discharge (or up to 28 days after enrollment).
measure: Duration of ventilation use
timeFrame: On the day of hospital discharge (expected up to 3 month).
measure: Length of stay in the ICU
timeFrame: On the day of hospital discharge (expected up to 3 month).
measure: Length of stay in the hospital
timeFrame: On the day of hospital discharge (expected up to 3 month).
measure: Adverse event
timeFrame: Through intervention completion, up to 28 days.
measure: Activities of daily living (ADL)
timeFrame: On the day of ICU discharge (up to 28 days after enrollment), hospital discharge (expected up to 3 month), and six-month after hospital discharge.
measure: Sleep quality
timeFrame: On the day of hospital discharge (expected up to 3 month) and six-month after hospital discharge.
measure: Quality of life (QoL)
timeFrame: On the day of hospital discharge (expected up to 3 month) and six-month after hospital discharge.
Other outcomes:
Locations:
Study officials:
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