UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of walking exercise prescription using anti-gravity treadmill for astronauts, who are going to Moon or Mars.
Title of the study (Brief title)	Training prescription for walking in lower gravity environment
Region	Japan North America

Condition
Condition	Walking disorder
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation of training prescription for walking under lower gravity environment
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Gravitational load-dependent walking patterns and trainability
Key secondary outcomes

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	Other
Interventions/Control_1	Walking on a treadmill
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	20 years-old <=
Age-upper limit	30 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy men and women
Key exclusion criteria	Individuals with health problem
Target sample size	30

Research contact person
Name of lead principal investigator	Yoshinobu Ohira
Organization	Doshisha University
Division name	Faculty and Graduate School of Health & Sports Science
Address	1-3 Tatara Miyakodani, Kyotanabe City, Kyoto
TEL	0774-65-7163
Email	yohira@mail.doshisha.ac.jp

Public contact
Name of contact person	Tetsuya Izawa
Organization	Doshisha University
Division name	Faculty and Graduate School of Health & Sports Science
Address	1-3 Tatara Miyakodani, Kyotanabe City, Kyoto
TEL	0774-65-6721
Homepage URL
Email	tizawa@mail.doshisha.ac.jp

Sponsor
Institute	Doshisha University
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	Doshisha University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 30 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 07 Month 08 Day
Anticipated trial start date	2015 Year 09 Month 20 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	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 06 Month 29 Day
Last modified on	2016 Year 06 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026444