UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051582 |
|---|---|
| Receipt number | R000058852 |
| Scientific Title | Evaluating optimal rehabilitation strategies in ICU: study protocol for a multicentre cohort study to assess physical activity dosing, muscle mass, and physical outcomes |
| Date of disclosure of the study information | 2024/02/01 |
| Last modified on | 2024/07/13 20:07:58 |
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Basic information
Public title
Evaluating optimal rehabilitation strategies in ICU: study protocol for a multicentre cohort study to assess physical activity dosing, muscle mass, and physical outcomes
Acronym
Evaluating optimal rehabilitation strategies in ICU: study protocol for a multicentre cohort study to assess physical activity dosing, muscle mass, and physical outcomes
Scientific Title
Evaluating optimal rehabilitation strategies in ICU: study protocol for a multicentre cohort study to assess physical activity dosing, muscle mass, and physical outcomes
Scientific Title:Acronym
Evaluating optimal rehabilitation strategies in ICU: study protocol for a multicentre cohort study to assess physical activity dosing, muscle mass, and physical outcomes
Region
| Japan |
Condition
Condition
Critical ill patients (Mechanically ventilated patients)
Classification by specialty
| Emergency medicine | Intensive care medicine | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Objectives
Specific aims
The specific aims of IPAMICS study are:
1. Short-term progression of muscle atrophy
2. Short-term improvements in symptoms, quality of life (QoL), and survival
3. Highest mobilization Level achieved in early rehabilitation, time, frequency, dose, time to first mobilization and its effect on physical PICS
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
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.
Key secondary outcomes
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.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who enter ICU for the first time and are expected to be on a ventilator for more than 2 days
Key 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
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Watanabe |
Organization
National Hospital Organization, Nagoya Medical Center
Division name
Rehabilitation
Zip code
500-8281
Address
4-1-1, Sannomaru, Naka-ku, Nagoya, Aichi, Japan
TEL
510582745001
billabonghonor@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Watanabe |
Organization
Nagoya Medical Center
Division name
Rehabilitation
Zip code
4600001
Address
4-1-1, Sannomaru, Naka-ku, Nagoya, Aichi, Japan
TEL
09044695520
Homepage URL
billabonghonor@yahoo.co.jp
Sponsor or person
Institute
National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya Medical Center
Address
4-1-1, Sannomaru, Naka-ku, Nagoya, Aichi, Japan
Tel
052-951-1111
billabonghonor@yahoo.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to investigate epidemiology such as physical PICS incidence rate, rehabilitation contents (physical activity amount, intensity, number of times, frequency, type) for mechanically ventilated patients admitted to ICU. The purpose of this study is to evaluate the correlation between the amount of physical activity in the elderly and how it affects the occurrence of PICS after discharge from the hospital.
Purpose 1: Epidemiological research
Purpose 2: Investigation of rehabilitation content
Objective 3: Investigation of the relationship between the amount of physical activity during ICU admission and the occurrence of physical PICS after discharge
Management information
Registered date
| 2023 | Year | 07 | Month | 11 | Day |
Last modified on
| 2024 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058852
