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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020670
Receipt No. 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

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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
Email 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
Email phmikmd@hosei.ac.jp

Sponsor
Institute Tokyo Metropolitan Institute of Gerontology
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022426

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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