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| Name | Class |
|---|---|
| Taipei Medical University Hospital | OTHER |
| National Science and Technology Council, Taiwan | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Technology-assisted early mobilization group | Experimental | 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. |
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| Systematic early mobilization group | Active Comparator | Participants allocated to the systematic early mobilization group will receive the same protocol-oriented early mobilization program within 72 hours of ventilator use. |
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| Usual care group | No Intervention | Participants in the usual care group will receive routine rehabilitation treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Technology-assisted, family-engaged in-bed activities | Other | Technology-assisted, family-engaged in-bed activities include handgrip interactive games, virtual reality butterfly catching, virtual reality magic cube games, and immersive in-bed cycling, performed 20 minutes per session, twice daily, five days a week, primarily assisted by family members. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of intensive care unit-acquired weakness (ICUAW) | 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. | On the day of enrollment and ICU discharge (or up to 28 days after enrollment). |
| Measure | Description | Time Frame |
|---|---|---|
| Muscle power | 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. | On the day of enrollment and ICU discharge (or up to 28 days after enrollment). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hsiao-Yean Chiu, Ph.D. | Contact | +886-2-27361661#6329 | hychiu0315@tmu.edu.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University Hospital | Recruiting | Taipei | 110 | Taiwan |
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| Protocol-oriented early mobilization program | Other | The protocol-oriented early mobilization program is implemented based on the patient's muscle strength and the Intensive care unit Mobility Scale (IMS), including lying, sitting, standing, stepping, and walking, once daily for 20-60 minutes, five days a week, carried out by physiotherapist and researcher. |
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| Hand-grip strength |
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. |
| On the day of enrollment and ICU discharge (or up to 28 days after enrollment). |
| Delirium | 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. | Through intervention completion, up to 28 days. |
| Subjective sleep status | 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. | Through intervention completion, up to 28 days. |
| Objective sleep status | 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. | Through intervention completion, up to 28 days. |
| Functional Status | 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. | On the day of enrollment and ICU discharge (or up to 28 days after enrollment). |
| Duration of ventilation use | 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. | On the day of hospital discharge (expected up to 3 month). |
| Length of stay in the ICU | The length of stay in the ICU will be recorded from the hospital's electronic system. | On the day of hospital discharge (expected up to 3 month). |
| Length of stay in the hospital | The total length of stay in the hospital will be recorded from the hospital's electronic system. | On the day of hospital discharge (expected up to 3 month). |
| Adverse event | Any adverse events occur during the intervention session. | Through intervention completion, up to 28 days. |
| Activities of daily living (ADL) | 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. | 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. |
| Sleep quality | 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. | On the day of hospital discharge (expected up to 3 month) and six-month after hospital discharge. |
| Quality of life (QoL) | 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. | On the day of hospital discharge (expected up to 3 month) and six-month after hospital discharge. |
| psychological distress | Depression, anxiety, and stress-21 items (DASS-21) will be used to assess patients' level of psychological distress. It contains 21 items, using the likert scale, where 0 indicates no effect, 1 indicates occasional effect, 2 indicates very effective, and 3 indicates extremely effective. There are seven items each for depression, anxiety, and stress. The total score for each item is calculated by adding them together and multiplying by two, ranging from 0 to 42. Higher scores indicate a more severe mood disorder. This scale has been proven to have good reliability and efficacy in medical institutions, community environments, various cultural groups, and healthy individuals, and is also commonly used for critically ill patients. | On the day of enrollment, ICU discharge (or up to 28 days after enrollment), on the day of hospital discharge (expected up to 3 month), and six-month after hospital discharge. |