Evaluating optimal rehabilitation strategies in ICU: study protocol for a multicentre cohort study to assess physical activity dosing, muscle mass, and physical outcomes

Evaluating optimal rehabilitation strategies in ICU: study protocol for a multicentre cohort study to assess physical activity dosing, muscle mass, and physical outcomes - Evaluating optimal rehabilitation strategies in ICU: study protocol for a multicentre cohort study to assess physical activity dosing, muscle mass, and physical outcomes

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000051582

Enrollment

500

Registered

2024-02-01

Start date

2024-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical ill patients (Mechanically ventilated patients)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who enter ICU for the first time and are expected to be on a ventilator for more than 2 days

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactShinichi Watanabe

Nagoya Medical Center Rehabilitation

billabonghonor@yahoo.co.jp09044695520

Outcome results