UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008639 |
|---|---|
| Receipt number | R000010152 |
| Scientific Title | An exercise protocol to prevent deterioration of cardiac function during long-term space flight |
| Date of disclosure of the study information | 2012/08/08 |
| Last modified on | 2013/08/02 13:38:36 |
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Basic information
Public title
An exercise protocol to prevent deterioration of cardiac function during long-term space flight
Acronym
An exercise protocol to prevent deterioration of cardiac function during long-term space flight
Scientific Title
An exercise protocol to prevent deterioration of cardiac function during long-term space flight
Scientific Title:Acronym
An exercise protocol to prevent deterioration of cardiac function during long-term space flight
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop JAXA's original exercise protocol that can control the increase of energy expenditure and prevent the deterioration of cardiac function and to verify its effectiveness through ground-based experiments.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximal Oxygen Consumption
Key secondary outcomes
Myocardial Mass
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Sprint interval training (total 10 min),
an 8-week, 5 times/wk, cycling exercise intervention
Interventions/Control_2
High-intensity interval aerobic training (total 18 min), an 8-week, 5 times/wk, cycling exercise intervention
Interventions/Control_3
Continuous aerobic training (total 45 min)
, an 8-week, 5 times/wk, cycling exercise intervention
Interventions/Control_4
High-intensity interval aerobic training (total 18 min), an 8-week, 3 times/wk, cycling exercise intervention
Interventions/Control_5
Continuous aerobic training (total 45 min)
, an 8-week, 3 times/wk, cycling exercise intervention
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
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
Normal body weight, Good physical condition
Key exclusion criteria
A person who participate in regular sports activities for the past year, Smokers
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoaki Matsuo |
Organization
National Institute of Occupational Safety and Health, Japan
Division name
Hazard Evaluation and Epidemiology Research Group
Zip code
Address
6-21-1 Nagao, Tama-ku, Kawasaki, Kanagawa, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Institute of Occupational Safety and Health, Japan
Division name
Hazard Evaluation and Epidemiology Research Group
Zip code
Address
TEL
Homepage URL
matsuo@h.jniosh.go.jp
Sponsor or person
Institute
Japan Aerospace Exploration Agency
Institute
Department
Personal name
Funding Source
Organization
Japan Aerospace Exploration Agency
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
University of Tsukuba
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
| 2012 | Year | 08 | Month | 08 | 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
| 2011 | Year | 02 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2011 | 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
| 2012 | Year | 08 | Month | 07 | Day |
Last modified on
| 2013 | 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=R000010152
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
