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 fifty years old or older, undergoing planned head and neck surgery
Classification by specialty	Oto-rhino-laryngology Oral surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	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	Change in cognitive function, depression incidence rate, number of hospital days, mortality rate, presence or absence of other adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Passive cycling exercise by bedside ergometer for twenty minutes.
Interventions/Control_2	early mobilization
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	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients, aged fifty years or older, undergoing planned head and neck surgery in Nagoya University school of medicine
Key exclusion criteria	1. MMSE<22, schizophrenia, mood disorders 2. alcohol abuse, stimulant drug abuse history 3. severe visual or aiditory deficits 4. comatose 5. applicant unsuitable for the research decided by principal investigator.
Target sample size	230

Research contact person
Name of lead principal investigator	MAIKO SATOMOTO
Organization	Nagoya University
Division name	Department of Anesthesiology
Address	65 Tsurumai, Nagoya
TEL	052-744-2340
Email	satomoto@med.nagoya-u.ac.jp

Public contact
Name of contact person	MAIKO SATOMOTO
Organization	Nagoya University
Division name	Department of Anesthesiology
Address	65 Tsurumai, Nagoya
TEL	052-744-2340
Homepage URL
Email	satomoto@med.nagoya-u.ac.jp

Sponsor
Institute	Nagoya University
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 11 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 01 Day
Anticipated trial start date	2017 Year 07 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	2017 Year 04 Month 28 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=R000031151