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

Not Applicable

Not yet recruiting

• Conditions: Intensive Care Unit Acquired Weakness

• Registration Number: NCT06700694
• Lead Sponsor: Hsiao-Yean Chiu

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-01
• Study First Submitted QC: 2024-11-19
• Last Update Submitted: 2024-11-19
• Study First Posted: 2024-11-22
• Last Update Posted: 2024-11-22
• Study Start: 2025-02
• Primary Completion: 2027-02
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 138

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Occurrence of intensive care unit-acquired weakness (ICUAW)	On the day of enrollment and ICU discharge (or up to 28 days after enrollment).	The occurrence of ICUAW will primarily be assessed using the Medical Research Council (MRC) scale. An MRC sum score of less than 48 indicates the presence of ICUAW.

Secondary Outcome Measures

Name	Time	Method
Muscle power	On the day of enrollment and ICU discharge (or up to 28 days after enrollment).	Muscle power will be evaluated using the MRC scale, which assesses the strength of six bilateral muscle groups rated from 0 (complete paralysis) to 5 (normal strength) for each group. The total score ranges from 0 to 60.
Hand-grip strength	On the day of enrollment and ICU discharge (or up to 28 days after enrollment).	Hand-grip strength will be measured using a hydraulic hand dynamometer. A strength of less than 11 kg for males and less than 7 kg for females indicates the presence of ICUAW. This outcome will be used to assess the occurrence of ICUAW, as determined by the MRC sum score, concurrently.
Delirium	Through intervention completion, up to 28 days.	Delirium is assessed by the Intensive Care Delirium Screening Checklist (ICDSC), which includes eight items. Each item is scored as absent (0) or present (1), with total score ranging from 0 to 8. A score of ≥ 4 indicates the presence of delirium. The scoring is based on observations during every nursing shift.
Subjective sleep status	Through intervention completion, up to 28 days.	Richards-Campbell Sleep Questionnaire (RCSQ) will be used to assess subjective sleep quality on a visual analog scale among patients in the ICU. The total score is calculated with a formula and categorized into four levels: \< 26 is very poor, 26-50 is poor, 51-75 is good, and \> 76 is excellent.
Objective sleep status	Through intervention completion, up to 28 days.	Objective sleep status will be evaluated by SOMNOwatch™, which can extract not only sleep related parameters but also calculate sleep stages using additional electroencephalography (EEG) sensors.
Functional Status	On the day of enrollment and ICU discharge (or up to 28 days after enrollment).	Functional Status Score for the Intensive Care Unit (FSS-ICU) is used to assess the functional status of patients in the ICU. Patient's performance of five functional movements will be rated from 0 to 7. The total score ranges from 0 to 35, with higher scores indicating better functional status.
Duration of ventilation use	On the day of hospital discharge (expected up to 3 month).	The duration of ventilation use is specified the accumulated days of using mechanical ventilation with endotracheal tube in the ICU for this hospitalization. This outcome will be recorded from the hospital's electronic system.
Length of stay in the ICU	On the day of hospital discharge (expected up to 3 month).	The length of stay in the ICU will be recorded from the hospital's electronic system.
Length of stay in the hospital	On the day of hospital discharge (expected up to 3 month).	The total length of stay in the hospital will be recorded from the hospital's electronic system.
Adverse event	Through intervention completion, up to 28 days.	Any adverse events occur during the intervention session.
Activities of daily living (ADL)	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.	The ADL will be assessed by the Barthel Index. The total score ranges from 0 to 100. A score of ≥ 70 indicates independent daily living abilities.
Sleep quality	On the day of hospital discharge (expected up to 3 month) and six-month after hospital discharge.	The Pittsburgh Sleep Quality Index (PSQI) is used to assess sleep quality over the past month. Score ranges from 0 to 21, with a score \> 5 indicating poor sleep quality; higher scores reflect worse sleep quality.
Quality of life (QoL)	On the day of hospital discharge (expected up to 3 month) and six-month after hospital discharge.	The EuroQol Five-Dimensional Five-Level Scale (EQ-5D-5L) is used to evaluate health-related QoL. The health status classification comprises five dimensions, each with five levels, calculated using specific values. The vertical analog scale assesses the patient's overall evaluation of their current health status, ranging from 0 to 100. Higher scores indicate greater QoL.