UMIN-CTR Clinical Trial

Basic information
Public title	Early rehabilitation provided by specialized physical therapist in an emergency center affects return to independent ADL in patients with sepsis: A retrospective cohort study
Acronym	Early rehabilitation provided by specialized physical therapist affects return to independent ADL in patients with sepsis
Scientific Title	Early rehabilitation provided by specialized physical therapist in an emergency center affects return to independent ADL in patients with sepsis: A retrospective cohort study
Scientific Title:Acronym	Early rehabilitation provided by specialized physical therapist affects return to independent ADL in patients with sepsis
Region	Japan

Condition
Condition	Sepsis Septic shock
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aimed to investigate the early rehabilitation provided by specialized physical therapist affects return to independent ADL in patients with sepsis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	ADL recovery using the Barthel index. Barthel index was evaluated by physical therapist at discharge from hospital.
Key secondary outcomes	Length of hospital stay and discharge outcome.

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	Not applicable
Gender	Male and Female
Key inclusion criteria	The subjects of this study were sepsis patients who entered the AECCC of Shinshu University Hospital between April 2014 and March 2020.
Key exclusion criteria	Patients with head injuries, burns, spinal injuries, lower limbs with multiple fractures, and those with septic shock who were unresponsive to maximal treatment, moribund or had an expected mortality within 48 h were excluded.
Target sample size	128

Research contact person
Name of lead principal investigator	1st name Yasunari Middle name Last name Sakai
Organization	Shinshu University Hospital
Division name	Rehabilitation
Zip code	390-8621
Address	3-1-1 Asahi, Matsumoto-shi, Nagano
TEL	0263-37-2836
Email	yasunari_sakai1028@yahoo.co.jp

Public contact
Name of contact person	1st name Yasunari Middle name Last name Sakai
Organization	Shinshu University Hospital
Division name	Rehabilitation
Zip code	390-8621
Address	3-1-1 Asahi, Matsumoto-shi, Nagano
TEL	0263-37-2836
Homepage URL
Email	yasunari_sakai1028@yahoo.co.

Sponsor
Institute	Shinshu University Hospital
Institute
Department

Funding Source
Organization	Non.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Shinshu University
Address	3-1-1 Asahi, Matsumoto-shi, Nagano
Tel	0263-37-2572
Email	mdrinri@shinshu-u.ac.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	信州大学医学部附属病院（長野県）

Other administrative information
Date of disclosure of the study information	2020 Year 05 Month 28 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	128
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	Completed
Date of protocol fixation	2018 Year 09 Month 12 Day
Date of IRB	2018 Year 09 Month 12 Day
Anticipated trial start date	2018 Year 09 Month 12 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Participant age, sex, body mass index (BMI), sequential organ failure assessment (SOFA) score, systemic inflammatory response syndrome (SIRS) score, disseminated intravascular coagulation (DIC) score, laboratory data (procalcitonin), primary source of infection, use of therapeutic medication, use of mechanical ventilation, BI baseline and discharge, length of hospital stay, patients discharge outcome and the number of days until rehabilitation were recorded.

Management information
Registered date	2020 Year 05 Month 28 Day
Last modified on	2020 Year 05 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046287