UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001430 |
|---|---|
| Receipt number | R000001735 |
| Scientific Title | Exercise and Hot Spa: Randomized Control Trial in Kawane Spa |
| Date of disclosure of the study information | 2008/10/14 |
| Last modified on | 2011/04/21 13:15:21 |
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Basic information
Public title
Exercise and Hot Spa: Randomized Control Trial in Kawane Spa
Acronym
Kawane Spa Study
Scientific Title
Exercise and Hot Spa: Randomized Control Trial in Kawane Spa
Scientific Title:Acronym
Kawane Spa Study
Region
| Japan |
Condition
Condition
healthy persons
Classification by specialty
| Medicine in general | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of hot spa and exercise course
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
data of medical checkup, POMS, SF-8, SDS and others
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
exercise in hot spa, bath in hot spa
Interventions/Control_2
lecture
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
healthy volunteer
Key exclusion criteria
subjects who are prohibited bath and exercise by physicians
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinya Hayasaka |
Organization
Hamamatsu University School of Medicine
Division name
Depf of Community Health and Preventive Medicine
Zip code
Address
1-20-1 Handayama Higashiku Hamamatsu
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Hamamatsu University School of Medicine
Division name
Depf of Community Health and Preventive Medicine
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shimada City
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japan Health & Research Institute
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 10 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2008 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
HAYASAKA Shinya SHIBATA Yosuke SUGIMURA Itaru GOTO Yasuaki HASEGAWA Takuya YASUDA Takako OHTA Keisuke MITO Haruka NODA Tatsuya MURATA Chiyoe OJIMA Toshiyuki. Effecfs of underwater exercise on quality of life and psychological states in Kawane Spa: a randomized controlled trial (Kawane Spa Study). The 62nd General Assembly and Internationa Thermalism/Scientific Congress of the World Federation of Hydrotherapy and Climatotherapy (FEMTEC), Yokohama, November 8-12, 2009
Management information
Registered date
| 2008 | Year | 10 | Month | 14 | Day |
Last modified on
| 2011 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001735
