UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007498 |
|---|---|
| Receipt number | R000008851 |
| Scientific Title | The effects of an exercise program on psychological well-being in postpartum mothers: a randomized controlled trial. |
| Date of disclosure of the study information | 2012/03/14 |
| Last modified on | 2012/03/13 22:53:45 |
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Basic information
Public title
The effects of an exercise program on psychological well-being in postpartum mothers: a randomized controlled trial.
Acronym
The effects of an exercise program on psychological well-being in postpartum mothers.
Scientific Title
The effects of an exercise program on psychological well-being in postpartum mothers: a randomized controlled trial.
Scientific Title:Acronym
The effects of an exercise program on psychological well-being in postpartum mothers.
Region
| Japan |
Condition
Condition
Healthy postpartum women
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study aimed to evaluate the effectiveness of a postpartum exercise program on psychological well-being.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Health-related quality of life (QOL) using MOS Short-Form 36-Item Health Survey (SF-36v2)
Key secondary outcomes
Rosenberg Self-Esteem Scale (RSES), Edinburgh Postnatal Depression Scale (EPDS) , Subjective Fatigue Symptom scale, sleeping condition, Pregnancy Physical Activity Questionnaire (PPAQ)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Exercise class (weekly exercise of 90 minutes for 4 weeks) at 3 months postpartum
Interventions/Control_2
Usual care
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
| Not applicable |
Gender
Female
Key inclusion criteria
Healthy postpartum women
Key exclusion criteria
Women with restricted physical activity or suffering from psychiatric disorders.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Megumi Haruna |
Organization
The University of Tokyo
Division name
Division of Health Sciences & Nursing, Graduate School of Medicine
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The University of Tokyo
Division name
Division of Health Sciences & Nursing, Graduate School of Medicine
Zip code
Address
TEL
Homepage URL
mharuna-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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 | 03 | 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
| 2007 | Year | 02 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 02 | Month | 01 | 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 | 03 | Month | 13 | Day |
Last modified on
| 2012 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008851
| Research Plan | |
|---|---|
| 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 |
