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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014177
Receipt No. R000016512
Official scientific title of the study The Effect of High Intensity Interval Exercise on the Thigh Muscle
Date of disclosure of the study information 2014/06/05
Last modified on 2014/06/25

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Basic information
Official scientific title of the study The Effect of High Intensity Interval Exercise on the Thigh Muscle
Title of the study (Brief title) The Effect of HIIE on the Thigh
Region
Japan

Condition
Condition Volunteers without severe comorbidities
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the mechanical and chemical stress on thigh muscles during high intensity interval exercise using ergometer with different cadences
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Muscle activity level
Key secondary outcomes Blood lactate concentration
Power output
Heart rate
Rate of perceived exertion

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 Treatment
Type of intervention
Other
Interventions/Control_1 High Intensity Interval Exercise
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
18 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria availability of a letter of consent
without severe comorbidity

Key exclusion criteria unable to perform high intensity interval exercise
Target sample size 40

Research contact person
Name of lead principal investigator Koichiro Azuma
Organization School of Medicine, Keio University
Division name Institute for Integrated Sports Medicine
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Email azumakx@z6.keio.jp

Public contact
Name of contact person Koichiro Azuma
Organization School of Medicine, Keio University
Division name Institute for Integrated Sports Medicine
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 03-3353-1211
Homepage URL
Email azumakx@z6.keio.jp

Sponsor
Institute Institute for Integrated Sports Medicine, School of Medicine, Keio 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 Institute for Integrated Sports Medicine, School of Medicine, Keio University
Organization
Division
Category of Funding Organization Self funding
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
2014 Year 06 Month 05 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2014 Year 05 Month 07 Day
Anticipated trial start date
2014 Year 06 Month 06 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
2014 Year 06 Month 05 Day
Last modified on
2014 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016512


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