UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of perioperative passive cycling exercise on postoperative delirium, cognitive function:Randomized controlled trial.
Title of the study (Brief title)	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	MAIKO SATOMOTO
Organization	Tokyo Medical and Dental University
Division name	Department of Anesthesiology, Graduate School of Medical and Dental Sciences
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	MAIKO SATOMOTO
Organization	Tokyo Medical and Dental University
Division name	Department of Anesthesiology, Graduate School of Medical and Dental Sciences
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519, Japan.
TEL	03-5803-5325
Homepage URL
Email	satomoto.mane@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University, Graduate School of Medical and Dental Sciences.
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027719