UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	Effects of walking in water and walking on land on pregnancy-induced hypertension
Region	Japan

Condition
Condition	Pregnancy-induced hypertension
Classification by specialty	Obsterics 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	Tatsuya Yoshihara
Organization	Faculty of Medical Science, Kyushu University
Division name	Department of Clinical Pharmacology
Address	3-1-1 Maidashi Higashi-ku Fukuoka
TEL	092-642-6082
Email	tatsuya@clipharm.med.kyushu-u.ac.jp

Public contact
Name of contact person	Tatsuya Yoshihara
Organization	Faculty of Medical Science, Kyushu University
Division name	Department of Clinical Pharmacology
Address	3-1-1 Maidashi Higashi-ku Fukuoka
TEL	092-642-6082
Homepage URL
Email	tatsuya@clipharm.med.kyushu-u.ac.jp

Sponsor
Institute	Department of Clinical Pharmacology, Faculty of Medical Science, Kyushu University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 09 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010618