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
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
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
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
