UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029002
Receipt No. R000033183
Scientific Title Time seies study development and evalution on self-execise yoga program for elderly primipara.
Date of disclosure of the study information 2018/09/01
Last modified on 2018/09/12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Time seies study development and evalution on self-execise yoga program for elderly primipara.
Acronym Time seies study development and evalution on self-execise yoga program for elderly primipara.
Scientific Title Time seies study development and evalution on self-execise yoga program for elderly primipara.
Scientific Title:Acronym Time seies study development and evalution on self-execise yoga program for elderly primipara.
Region
Japan

Condition
Condition Eldery primipara
Classification by specialty
Nursing Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We develop a self-exercise yoga program during pregnancy for eldery primipara,and evaluate physical relaxation and psychological effects
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes State Trait Anxiety Inventory[STAI](Spielberger,1970)
Four weeks from the start
Key secondary outcomes Profile of mood states[POMS](McNair,1971)
The Scale of emotion as defined in terms of relaxation(Nedate,1984)
Muscle relaxation scale(Koitabashi,2004)
Four weeks from the start

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention period:4weeks
Intervention frequency :Three times a week
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
35 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria (1)Pregnant woman between 26th to 32th weeks of gestation
(2)shingleton pregnancy
(3)Pregnant woman who can read and understand Japanese

Key exclusion criteria (1)Pregnant woman with mental state instability
(2)A pregnant woman complaining of serious heart disease and/or respiratory disease
(3)Pregnant woman with threatened
premature delivey/cervical/incompetency/placenta previa/low lying placenta/pregnancy induced hypertension
(4)Pregnant woman who can not speak japanese
(5)Pregnant woman who is no experience of practicing yoga during pregnancy
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ono,Yoshie
Organization Japanese Red Cross College of Nursing
Division name Graduate School of Nursing ,Global Health Care and Midwifery
Zip code
Address 4-3-1 Hiroo,Shibuya-ku,Tokyo,150-0012,JAPAN
TEL 03-3409-0875
Email yoshie0907yoshie@ybb.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ono,Yoshie
Organization Japanese Red Cross College of Nursing
Division name Graduate School of Nursing ,Global Health Care and Midwifery
Zip code
Address 4-3-1 Hiroo,Shibuya-ku,Tokyo,150-0012,JAPAN
TEL 03-3409-0875
Homepage URL
Email yoshie0907yoshie@ybb.ne.jp

Sponsor
Institute Japanese Red Cross College of Nursing
Japanese Red Cross Medical center
Institute
Department

Funding Source
Organization None
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
Email

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
2018 Year 09 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 Preinitiation
Date of protocol fixation
2017 Year 08 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 02 Day
Last follow-up date
2017 Year 12 Month 20 Day
Date of closure to data entry
2017 Year 12 Month 25 Day
Date trial data considered complete
2017 Year 12 Month 25 Day
Date analysis concluded
2017 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 09 Month 05 Day
Last modified on
2018 Year 09 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033183

Research Plan
Registered date File name
2018/09/12 UMIN提出用研究計画書.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.