A survey of involvement of physical activity dose and muscle mass in the development of post-intensive care syndrome
Not Applicable
- Conditions
- Critical ill patients (Mechanically ventilated patients)
- Registration Number
- JPRN-UMIN000051582
- Lead Sponsor
- ational Hospital Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
Not provided
Exclusion Criteria
1. Under the age of 18 2. Patients who were unable to walk even with aids before hospitalization 3. End of life/Terminal care cases for which treatment is not the purpose 4. Patients who are expected to be restricted from getting out of bed for a long time due to unstable multiple fractures, burns, limb amputation, etc. associated with severe trauma. 5. Patients who did not give consent 6. Other
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcomes include SF-12 (Physical component summary; PCS) 3 months after discharge, which is the most important outcome of this study, and muscle atrophy of the rectus femoris muscle on day 7 of ICU admission. Physical PICS is defined as a PCS score less than 50 points at 3-month follow-up. Many patients may drop out of the study during follow-up. Therefore, we will focus on his results at 3 months.
- Secondary Outcome Measures
Name Time Method Secondary outcomes are evaluation scores such as SF-12 (Mental component summary; MCS), Barthel Index, Medical research council (MRC) score, Functional status score for the Intensive Care Unit (FSS-ICU), grip strength, Clinical frail scale (CFS), employment status, and readmission after discharge. We will also record adverse events during rehabilitation (falls, cardiac arrest, tachycardia >150 bpm, ventricular tachycardia, other dangerous arrhythmias, SPO2 <80% for >3 minutes, unplanned extubation, IV-line removal). Data will also be collected on the incidence of PICS-family, defined as family mental health disorders after a patient's discharge.