UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009051 |
|---|---|
| Receipt number | R000010618 |
| Scientific Title | Effects of walking in water and walking on land on blood pressure, plasma renin activity, oxidative stress, urine volume and creatinine clearance in pregnant women |
| Date of disclosure of the study information | 2012/10/05 |
| Last modified on | 2019/02/14 17:50:10 |
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Basic information
Public title
Effects of walking in water and walking on land on blood pressure, plasma renin activity, oxidative stress, urine volume and creatinine clearance in pregnant women
Acronym
Effects of walking in water and walking on land on pregnancy-induced hypertension
Scientific Title
Effects of walking in water and walking on land on blood pressure, plasma renin activity, oxidative stress, urine volume and creatinine clearance in pregnant women
Scientific Title:Acronym
Effects of walking in water and walking on land on pregnancy-induced hypertension
Region
| Japan |
Condition
Condition
Pregnancy-induced hypertension
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the effects of walking in water and walking on land on blood pressure, plasma renin activity, oxidative stress, urine volume and creatinine clearance in pregnant women
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes of plasma renin activity, oxidative stress, urine volume and creatinine clearance between walking in water and walking on land
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
Self control
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 in pool or on land for 1 hour
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
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
Older than 20 and younger than 40 years old women with normal pregnancy of 37 weeks or more
Pregnant women who have attended the program of walking-in-water
Key exclusion criteria
1.History of cardiovascular disease
2.Person who is diagnosed as placenta previa or low-lying placenta
3.Person who have amniorrhexis
4.Person who have hypertension or diabetes mellitus
5.On medical treatment
6.Hemoglobin<10 g/dL
7.Person who cannot walk normally
8.Not appropriate to this study by other reasons
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Yoshihara |
Organization
Faculty of Medical Science, Kyushu University
Division name
Department of Clinical Pharmacology
Zip code
Address
3-1-1 Maidashi Higashi-ku Fukuoka
TEL
092-642-6082
tatsuya@clipharm.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Yoshihara |
Organization
Faculty of Medical Science, Kyushu University
Division name
Department of Clinical Pharmacology
Zip code
Address
3-1-1 Maidashi Higashi-ku Fukuoka
TEL
092-642-6082
Homepage URL
tatsuya@clipharm.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Clinical Pharmacology, Faculty of Medical Science, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 05 | 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
| 2012 | Year | 09 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 09 | 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
| 2012 | Year | 10 | Month | 05 | Day |
Last modified on
| 2019 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010618
| Research Plan | |
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| 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 |
