UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024076
Receipt number R000027719
Scientific Title Impact of perioperative passive cycling exercise on postoperative delirium, cognitive function:Randomized controlled trial.
Date of disclosure of the study information 2017/01/01
Last modified on 2017/10/28 10:26:54

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Basic information

Public title

Impact of perioperative passive cycling exercise on postoperative delirium, cognitive function:Randomized controlled trial.

Acronym

Exercise and postoperative delirium

Scientific Title

Impact of perioperative passive cycling exercise on postoperative delirium, cognitive function:Randomized controlled trial.

Scientific Title:Acronym

Exercise and postoperative delirium

Region

Japan


Condition

Condition

Patients aged sixty five years old or older undergoing planned cardiac surgery or esophagectomy.

Classification by specialty

Gastrointestinal surgery Vascular surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Patients aged sixty five years old or older undergoing planned cardiac surgery or esophagectomy are divided into two groups, exercise therapy group or control group. 1. We aim to examine whether exercise is effective for the prevention of delirium, or not.
2. We investigate the relationships between risk factors of delirium and exercise therapy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Incidence of delirium as determined by the DSM-5.

Key secondary outcomes


association between values of CRP, PCT, IL-6, and BDNF and subsequent delirium.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Passive cycling exercise by bedside ergometer for ten minutes.

Interventions/Control_2

1.

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

Patients aged sixty five years or older undergoing planned cardiac surgery or esophagectomy in Tokyo Medical and Dental University

Key exclusion criteria

1.comatose
2.incapable of passive cycling exercise by bedside ergometer for ten minutes.
3.In case of emergency, incapable of preoperative exercise,MRI, MMSE cognitive test before surgery.
4.who is expected to follow unpleasant course after complicated surgery.
5.applicant unsuitable for the research decided by principal investigator.

Target sample size

180


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name MAIKO SATOMOTO

Organization

Tokyo Medical and Dental University

Division name

Department of Anesthesiology, Graduate School of Medical and Dental Sciences

Zip code


Address

1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan.

TEL

03-5803-5325

Email

satomoto.mane@tmd.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name MAIKO SATOMOTO

Organization

Tokyo Medical and Dental University

Division name

Department of Anesthesiology, Graduate School of Medical and Dental Sciences

Zip code


Address

1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan.

TEL

03-5803-5325

Homepage URL


Email

satomoto.mane@tmd.ac.jp


Sponsor or person

Institute

Tokyo Medical and Dental University, Graduate School of Medical and Dental Sciences.

Institute

Department

Personal name



Funding Source

Organization

Japanese Society of Anesthesiologists

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


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

2017 Year 01 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

Completed

Date of protocol fixation

2016 Year 09 Month 30 Day

Date of IRB


Anticipated trial start date

2017 Year 01 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 09 Month 15 Day

Last modified on

2017 Year 10 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027719


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name