Technology-Assisted Early Mobilization Program Among Patients in the Intensive Care Units

Hsiao-Yean Chiu

Status: Begins enrollment in 1 month

Conditions: Intensive Care Unit Acquired Weakness

Treatments: Other: Technology-assisted, family-engaged in-bed activities; Other: Protocol-oriented early mobilization program

Study type: Interventional

Funder types: Other

Identifiers

NCT06700694

N202403085

Details and patient eligibility

About

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.

Enrollment: 138 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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138 participants in 3 patient groups

Technology-assisted early mobilization group

Experimental group

Description:

Participants in the technology-assisted early mobilization group will receive protocol-oriented early mobilization program and technology-assisted, family-engaged in-bed activities within 72 hours of ventilator use.

Treatment:

Other: Protocol-oriented early mobilization program

Other: Technology-assisted, family-engaged in-bed activities

Systematic early mobilization group

Active Comparator group

Description:

Participants allocated to the systematic early mobilization group will receive the same protocol-oriented early mobilization program within 72 hours of ventilator use.

Treatment:

Other: Protocol-oriented early mobilization program

Usual care group

No Intervention group

Description:

Participants in the usual care group will receive routine rehabilitation treatment.