UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021185 |
|---|---|
| Receipt number | R000024428 |
| Scientific Title | Development of aerobic exercise protocols to improve VO2peak and cardiac mass in older adults: a preliminary trial |
| Date of disclosure of the study information | 2016/02/26 |
| Last modified on | 2017/08/07 09:16:03 |
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Basic information
Public title
Development of aerobic exercise protocols to improve VO2peak and cardiac mass in older adults: a preliminary trial
Acronym
Development of aerobic exercise protocols to improve VO2peak and cardiac mass in older adults: a preliminary trial
Scientific Title
Development of aerobic exercise protocols to improve VO2peak and cardiac mass in older adults: a preliminary trial
Scientific Title:Acronym
Development of aerobic exercise protocols to improve VO2peak and cardiac mass in older adults: a preliminary trial
Region
| Japan |
Condition
Condition
Healthy older adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To preliminary identify the adaptability of aerobic exercise protocols which improve VO2peak and cardiac mass in older adults
Basic objectives2
Others
Basic objectives -Others
To assess rate of accomplishment of novel exercise protocol
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of accomplishment of novel exercise protocol
Key secondary outcomes
Kinetics of oxygen consumption and heart rate during novel exercise protocol, rate of perceived exertion and mood after novel exercise protocol
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Continues aerobic training (one trial), Low-volume aerobic-type interval training (one trial)
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
| 60 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male
Key inclusion criteria
1) non-smoking, 2)not restricted by a doctor from exercising, 3)did not conduct a moderate-vigorous intensity aerobic training within 1 year 4) did not participate in other clinical trials within 1 year, 5)agree with informed consent
Key exclusion criteria
1)have histories of severe heart disease, cerebrovascular disease, and renal dysfunction, 2)have abnormality in an electrocardiogram, 3)are prohibited to participate in trail by safety control doctor, 4)not control joint pains during exercise
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoji Tanaka |
Organization
University of Tsukuba
Division name
Faculty of Health and Sport Sciences
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-2655
tanaka@taiiku.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yosuke Osuka |
Organization
Japan Aerospace Exploration Agency
Division name
Human Spaceflight Technology Directorate
Zip code
Address
1-1-1 Sengen, Tsukuba, Ibaraki
TEL
050-3362-8370
Homepage URL
ohsuka.yohsuke@jaca.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science, University of Tsukuba
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japan Aerospace Exploration Agency
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
筑波大学総合研究棟D（茨城県）、University of Tsukuba, Comprehensive research building
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 26 | 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 | 02 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 05 | 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 | 02 | Month | 24 | Day |
Last modified on
| 2017 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024428
| 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 |
