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Recruitment status Completed
Unique ID issued by UMIN UMIN000021185
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email ohsuka.yohsuke@jaca.jp

Sponsor
Institute University of Tsukuba
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024428


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