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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016210
Receipt No. R000018809
Scientific Title Relationship between slow gait speed and post-operative delirium in elderly patients
Date of disclosure of the study information 2015/01/15
Last modified on 2019/04/08

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Basic information
Public title Relationship between slow gait speed and post-operative delirium in elderly patients
Acronym Slow gait speed and post-operative delirium
Scientific Title Relationship between slow gait speed and post-operative delirium in elderly patients
Scientific Title:Acronym Slow gait speed and post-operative delirium
Region
Japan

Condition
Condition Urological disease
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess whether or not gait parameters in elderly patient is useful tool for prediction of post-operative delirium
Basic objectives2 Others
Basic objectives -Others Non-interventional trial; evaluation of optimal cut-off value
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes postoperative delirium
Key secondary outcomes Calculating the cu-off value for postoperative delirium, evaluation of risk factors for postoperative delirium

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
20 years-old <
Age-upper limit
95 years-old >
Gender Male and Female
Key inclusion criteria Patients who undergo urological surgery
Key exclusion criteria Patients with walking difficulty, and difficulties in giving fully informed consent
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shingo Hatakeyama
Organization Hirosaki University, Graduate School of Med
Division name Urology
Zip code
Address 53 Hontyou, Hirosaki
TEL 0172-39-5091
Email shingorilla2@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Shingo Hatakeyama
Organization Hirosaki University, Graduate School of Med
Division name Urology
Zip code
Address 53 Hontyou, Hirosaki
TEL 0172-39-5091
Homepage URL
Email shingorilla2@gmail.com

Sponsor
Institute Hirosaki University, Graduate School of Med
Institute
Department

Funding Source
Organization apan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 01 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications http://journals.plos.org/plosone/article?id=10.1371%2Fjournal.pone.0153961
Number of participants that the trial has enrolled
Results
Results

Median age of this cohort was 67 years. Ten patients (4.7%) experienced postoperative delirium. These patients were significantly older, had weak handgrip strength, a higher fall risk assessment score, slow gait speed, and greater renal function decline compared with patients without delirium. Multivariate analysis revealed slow gait speed (>13.0 s) and rapid renal function decline (>30%) were independent risk factors for postoperative delirium.

Conclusions

Slow gait speed and rapid renal function decline after urological surgery are significant factors for postoperative delirium. These data will be helpful for perioperative patient management. 
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
2013 Year 08 Month 19 Day
Date of IRB
2017 Year 01 Month 06 Day
Anticipated trial start date
2017 Year 02 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information Prospective, single-arm study

Management information
Registered date
2015 Year 01 Month 14 Day
Last modified on
2019 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018809

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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