UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026901
Receipt number R000030739
Scientific Title The relashionship between postoperative cognitive dysfunction and preoperative sarcopenia
Date of disclosure of the study information 2017/04/10
Last modified on 2021/10/12 09:36:45

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Basic information

Public title

The relashionship between postoperative cognitive dysfunction and preoperative sarcopenia

Acronym

POCD and sarcopenia

Scientific Title

The relashionship between postoperative cognitive dysfunction and preoperative sarcopenia

Scientific Title:Acronym

POCD and sarcopenia

Region

Japan


Condition

Condition

surgical patients

Classification by specialty

Orthopedics Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the relationship between sarcopenia and postoperative cognitive dysfunction

Basic objectives2

Others

Basic objectives -Others

risk factor of the postoperative cognitive dysfunction

Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

muscle mass and cognitive test

Key secondary outcomes

risk factor of the POCD


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

65 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

> 65 years old
the patients with orthopedic surgery
the patines obtained informed consent

Key exclusion criteria

the patients who do not complete the
cognitive tests

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Toru
Middle name
Last name Goyagi

Organization

Akita University Graduate School of Medicine

Division name

Department of Anesthesia and Intensive Care Medicine

Zip code

010-8543

Address

1-1-1, Hondo, Akita-city, Akita,

TEL

018-884-6175

Email

tgoyagi@doc.med.akita-u.ac.jp


Public contact

Name of contact person

1st name Toru
Middle name
Last name Goyagi

Organization

Akita University Graduate School of Medicine

Division name

Department of Anesthesia and Intensive Care Medicine

Zip code

010-8543

Address

1-1-1, Hondo, Akita-city, Akita,

TEL

018-884-6175

Homepage URL


Email

tgoyagi@doc.med.akita-u.ac.jp


Sponsor or person

Institute

Akita University

Institute

Department

Personal name



Funding Source

Organization

Akita University

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

Akita University

Address

1-1-1, Hondo, Akita-city, Akita,

Tel

018-884-6028

Email

soken@hos.akita-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



Other administrative information

Date of disclosure of the study information

2017 Year 04 Month 10 Day


Related information

URL releasing protocol

https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000030739&ty

Publication of results

Partially published


Result

URL related to results and publications

none

Number of participants that the trial has enrolled

11

Results

There were 11 subjects with a mean age of 77 years. None of the patients met the diagnostic criteria for sarcopenia using the SMI, but five patients had decreased grip strength. 2 of the 11 patients (18%) were judged to have POCD, and one of these patients had decreased grip strength.

Results date posted

2021 Year 10 Month 12 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Patients over the age of 65 undergoing spine surgery

Participant flow

Recruit in orthopedic surgery, measure muscle mass by DXA method, measure cognitive function before and after surgery

Adverse events

none

Outcome measures

Mini mental state examination, Digit spam test, Trail Making test (A,B), Kana-hiroi test

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 04 Month 01 Day

Date of IRB

2017 Year 03 Month 20 Day

Anticipated trial start date

2017 Year 04 Month 15 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry

2020 Year 03 Month 31 Day

Date trial data considered complete

2020 Year 03 Month 31 Day

Date analysis concluded

2020 Year 12 Month 31 Day


Other

Other related information

preoperative sarcopenia and cognitive tests


Management information

Registered date

2017 Year 04 Month 08 Day

Last modified on

2021 Year 10 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030739


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name