UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of aerobic exercise protocols to improve VO2peak and cardiac mass in older adults: a preliminary trial
Title of the study (Brief title)	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	Kiyoji Tanaka
Organization	University of Tsukuba
Division name	Faculty of Health and Sport Sciences
Address	1-1-1 Tennodai, Tsukuba, Ibaraki
TEL	029-853-2655
Email	tanaka@taiiku.tsukuba.ac.jp

Public contact
Name of contact person	Yosuke Osuka
Organization	Japan Aerospace Exploration Agency
Division name	Human Spaceflight Technology Directorate
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

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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