UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020670 |
|---|---|
| Receipt number | R000022426 |
| Scientific Title | Effect of compromised condition affected by ischemic cerebrovascular diseases on changes in regional cerebral blood flow evoked by exercise: measurements of cerebral blood flow during supine cycling exercise with positron emission tomography. |
| Date of disclosure of the study information | 2016/01/20 |
| Last modified on | 2017/08/02 10:00:54 |
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Basic information
Public title
Effect of compromised condition affected by ischemic cerebrovascular diseases on changes in regional cerebral blood flow evoked by exercise: measurements of cerebral blood flow during supine cycling exercise with positron emission tomography.
Acronym
Ischemic cerebrovascular diseases and cerebral blood flow: a PET study
Scientific Title
Effect of compromised condition affected by ischemic cerebrovascular diseases on changes in regional cerebral blood flow evoked by exercise: measurements of cerebral blood flow during supine cycling exercise with positron emission tomography.
Scientific Title:Acronym
Ischemic cerebrovascular diseases and cerebral blood flow: a PET study
Region
| Japan |
Condition
Condition
ischemic cerevrovacular diseases
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The subjects participated in this study are normal volunteers and patients who experienced ischemic cerebrovascular diseases but recovered to have good status for physical activity including exercise. The aim of the present study is to investigate changes in regional cerebral blood flow induced by exercise using PET with autoradiography method. The subjects perform exercise with lower intensity than 40% of peak pulmonary oxygen uptake.
Basic objectives2
Others
Basic objectives -Others
We examine the regions where changes in cerebral blood flow differ between normal volunteers and patients who experienced ischemic cerebrovascular diseases and elucidate possible risks induced by exercise.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in regional cerebral blood flow induced by exercise will compared between normal volunteers and patients who experienced ischemic cerebrovascular diseases, which will be evaluated after examining data of 8 subjects in the both groups (12~15 weeks from the onset of the study).
Key secondary outcomes
For patients who experienced ischemic cerebrovascular diseases, the association between ischemic regions and the magnitude of changes in regional cerebral blood flow induced by exercise will be evaluated after examining data of 12 subjects in the patients group (24~30 weeks from the onset of the study).
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Normal volunteers and patients who experienced ischemic cerebrovascular diseases whose age ranged from 20 to 50 years old are included if they are tolerable for continuing supine cycling ergometer exercise with lower intensity than 40% of peak pulmonary oxygen uptake for 20 minute.
Key exclusion criteria
The subjects are excluded if they are not tolerable for performing the 20 min of continuous exercise, as a results of physical examination and exercise tests.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiura Mikio |
Organization
Hosei University
Division name
Faculty of Sports and Health Studies
Zip code
Address
4342 Aihar-ch-, Machida-shi, Tokyo
TEL
042-783-2121
phmikmd@hosei.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiura Mikio |
Organization
Hosei University
Division name
Faculty of Sports and Health Studies
Zip code
Address
4342 Aihar-ch-, Machida-shi, Tokyo
TEL
042-783-2121
Homepage URL
phmikmd@hosei.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Gerontology
Institute
Department
Personal name
Funding Source
Organization
The Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Jaoan
Other related organizations
Co-sponsor
Tokyo Medica; and Dental University
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
東京都健康長寿医療センター(東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 20 | 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
As of June 2017, PET measurements were performed for fourteen normal volunteers and five patients suffered from ischemic cerebrovascular diseases in Tokyo Metropolitan Institute of Gerontology. For each subject, regional cerebral blood flow was investigated on six occasions while these subjects remained at rest, performed physical exercise on cycling ergometer at supine position and remained at rest again. rCBF was calculated by autoradiography method with 15O-H2O and functional imaging for rCBF was analyzed with SPM and Dr. View software. There were no adverse events and data were obtained according to the experimental protocols approved before.
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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 12 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Changes in regional cerebral blood flow during exercise are investigated by PET. As healthy volunteers are examined for a control group, patients of ischemic cerebrovascular diseases are also examined in order to clarify the influence of exercise to the ischemic region. Subjects for a control group are recruited from young healthy volunteers who are examined by exercise tests and medical check-up in Hosei University from 2015 to 2016, while subjects for a patient group are recruited from patients who visited a clinic of department of neurosurgery in Tokyo Medical and Dental University from 2015 to 2016. After examined by brain MRI, PET are performed for measurements of regional cerebral blood flow during exercise and before and following exercise as well. Physiological variables such as blood pressure and heart rate are observed in accordance with the PET procedures.
Management information
Registered date
| 2016 | Year | 01 | Month | 20 | Day |
Last modified on
| 2017 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022426
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