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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024249
Receipt No. R000027923
Scientific Title Effects of psychophysiological responses to regular exercise on post-exercise self-efficacy
Date of disclosure of the study information 2016/10/03
Last modified on 2018/04/03

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Basic information
Public title Effects of psychophysiological responses to regular exercise on post-exercise self-efficacy
Acronym Self-efficacy during regular exercise
Scientific Title Effects of psychophysiological responses to regular exercise on post-exercise self-efficacy
Scientific Title:Acronym Self-efficacy during regular exercise
Region
Japan

Condition
Condition healthy female university students
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to clarify the effects of psychophysiological responses during regular exercise on post-exercise self-efficacy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Post-exercise self-efficacy just after and 30-min after the exercise
Key secondary outcomes Subjective measures: Feeling Scale, Rating of Perceived Exertion
Physiological measures: Heart Rate, HRV indices autonomic activity level
height, weight, Pre-exercise self efficacy

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 30-min steady-state cycling exercise at 40% of HR reserve 5 times a week for 3 weeks
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
20 years-old <=
Age-upper limit
25 years-old >=
Gender Female
Key inclusion criteria healthy young females
Key exclusion criteria 1) BMI <18.5 or >=25
2) smoker
3) taking medicine affecting the autonomic system
4) pregnancy
5) subjects judged by the investigator to be ineligible for other reasons
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kentaro Yamanaka
Organization Showa Women's University
Division name Graduate School of Life Sciences
Zip code
Address 1-7, Taishido, Setagaya-ku, Tokyo
TEL 03-3411-7403
Email kentaro@swu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Yamanaka
Organization Showa Women's University
Division name Graduate School of Life Sciences
Zip code
Address 1-7, Taishido, Setagaya-ku, Tokyo
TEL 03-3411-7403
Homepage URL
Email kentaro@swu.ac.jp

Sponsor
Institute Showa Women's University
Institute
Department

Funding Source
Organization Showa Women's University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 昭和女子大学

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 03 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 No longer recruiting
Date of protocol fixation
2011 Year 10 Month 03 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 03 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 10 Month 01 Day
Last modified on
2018 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027923

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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