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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039793
Receipt No. R000045361
Scientific Title Early rehabilitation provided by specialized physical therapist in an emergency center reduces pulmonary complications in patients with sepsis: A retrospective cohort study
Date of disclosure of the study information 2020/03/12
Last modified on 2020/03/12

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Basic information
Public title arly rehabilitation provided by specialized physical therapist in an emergency center reduces pulmonary complications in patients with sepsis: A retrospective cohort study
Acronym Early rehabilitation and pulmonary complications
Scientific Title Early rehabilitation provided by specialized physical therapist in an emergency center reduces pulmonary complications in patients with sepsis: A retrospective cohort study
Scientific Title:Acronym Early rehabilitation and pulmonary complications
Region
Japan

Condition
Condition Sepsis
Classification by specialty
Emergency medicine Intensive care medicine Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this retrospective cohort study was to evaluate if early rehabilitation provided by specialized physical therapist in the emergency center could reduce respiratory complication in sepsis patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The primary outcome measure is the association between early mobilization by specialized physical therapy and the onset of a pulmonary complication.
The evaluation period is during the hospital stay.
Key secondary outcomes

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 2019.
Participants >18 years who received intensive treatment and were diagnosed with sepsis or septic shock and who met the inclusion criteria were enrolled.
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 24h 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.jp

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 03 Month 12 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
2019 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, sequential organ failure assessment score, systemic inflammatory response syndrome score, disseminated intravascular coagulation score, laboratory data, primary source of infection, use of therapeutic medication, use of mechanical ventilation, length of hospital stay, the number of days until rehabilitation was achieved, the baseline Barthel index, and the incidence of pulmonary complications are recorded.

Management information
Registered date
2020 Year 03 Month 12 Day
Last modified on
2020 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045361

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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