UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024249 |
|---|---|
| Receipt number | 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 10:43:07 |
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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
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
kentaro@swu.ac.jp
Sponsor or person
Institute
Showa Women's University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027923
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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