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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027181
Receipt No. R000031151
Scientific Title Impact of perioperative passive cycling exercise on postoperative delirium, cognitive function:Randomized controlled trial.
Date of disclosure of the study information 2017/11/01
Last modified on 2017/10/28

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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 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
1st name
Middle name
Last name MAIKO SATOMOTO
Organization Nagoya University
Division name Department of Anesthesiology
Zip code
Address 65 Tsurumai, Nagoya
TEL 052-744-2340
Email satomoto@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name MAIKO SATOMOTO
Organization Nagoya University
Division name Department of Anesthesiology
Zip code
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)

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 11 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
2017 Year 05 Month 01 Day
Date of IRB
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

Other
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

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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