UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029002 |
|---|---|
| Receipt number | 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 | 2019/09/16 19:51:39 |
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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 | ono,yoshie |
| 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
153-0012
Address
4-3-1 Hiroo,Shibuya-ku,Tokyo,150-0012,JAPAN
TEL
03-3409-0875
yoshie0907yoshie@ybb.ne.jp
Public contact
Name of contact person
| 1st name | yoshie |
| 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
153-0012
Address
4-3-1 Hiroo,Shibuya-ku,Tokyo,150-0012,JAPAN
TEL
03-3409-0875
Homepage URL
yoshie0907yoshie@ybb.ne.jp
Sponsor or person
Institute
Japanese Red Cross College of Nursing
Japanese Red Cross Medical center
Institute
Department
Personal name
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
Japanese Red Cross College
Address
4-3-1 Hiroo,Shibuya,Tokyo,150-0012,Japan
Tel
03-3409-0875
yoshie0907yoshie@ybb.ne.jp
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
| 2019 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.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 |
