UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012182 |
|---|---|
| Receipt number | R000014242 |
| Scientific Title | Beneficial effects of the Shikoku Walking Pilgrimage on mental and physical health |
| Date of disclosure of the study information | 2013/11/01 |
| Last modified on | 2017/05/26 19:55:37 |
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Basic information
Public title
Beneficial effects of the Shikoku Walking Pilgrimage on mental and physical health
Acronym
Effects of walking pilgrimage on health
Scientific Title
Beneficial effects of the Shikoku Walking Pilgrimage on mental and physical health
Scientific Title:Acronym
Effects of walking pilgrimage on health
Region
| Japan |
Condition
Condition
Healthy normal adults
Classification by specialty
| Medicine in general | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine whether the Shikoku Walking Pilgrimage could have an effect on the mental and physical health of walking participants.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Biochemical data (blood)
Lipid oxidative stress marker, BDNF, GOT, GPT, gamma-GTP, HDL cholesterol, LDL cholesterol, Triglycerides, Glucose, Uric acid, Urea nitrogen, Total bilirubin acid, Cholinesterase, CK, Amylase, Cortisol, NK cell activity, Immunoglobulin (IgG, IgA, IgM)
2.Biochemical data (urine)
Adrenaline, Noradrenaline, Dopamine, Creatinine
3.Biochmical data (saliva)
Cortisol, sIgA
4.Physiological data
Heart rate variability, body acceleration, Flicker perception frequency
5.Psychological data
Profile of Mood States (POMS)
One week before and after, and during intervention.
Key secondary outcomes
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
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Walking Shikoku pilgrimage and worshipping at temples
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
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
1.Healthy adults
2.Those whose informed consent can be obtained
Key exclusion criteria
1.Those who are recognized as unsuitable to the test by medical doctor.
2.Those who cannot agree to participate in this trial.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasukazu Yoshida |
Organization
National Institute of Advanced Industrial Science and Technology (AIST)
Division name
Health Research Institute
Zip code
Address
2217-14 Hayashichou, Takamatsu, 761-0395, Kagawa, Japan
TEL
+81-87-869-4149
yoshida-ya@aist.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasukazu Yoshida |
Organization
National Institute of Advanced Industrial Science and Technology (AIST)
Division name
Health Research Institute
Zip code
Address
2217-14 Hayashichou, Takamatsu, 761-0395, Kagawa, Japan
TEL
+81-87-869-4149
Homepage URL
yoshida-ya@aist.go.jp
Sponsor or person
Institute
Health Research Institute, National Institute of Advanced Industrial Science and Technology (AIST)
Institute
Department
Personal name
Funding Source
Organization
National Institute of Advanced Industrial Science and Technology (AIST)
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
独立行政法人産業技術総合研究所
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 01 | 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
Completed
Date of protocol fixation
| 2011 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 31 | Day |
Last modified on
| 2017 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014242
| 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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| Registered date | File name |
