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

H

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

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.

Trial contacts and locations

0

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Central trial contact

Hsiao-Yean Chiu, Ph.D.

Data sourced from clinicaltrials.gov

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