UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050966 |
|---|---|
| Receipt number | R000057838 |
| Scientific Title | Development of a comprehensive care program for muscle fatigue in postpartum women and an evaluation of its effectiveness |
| Date of disclosure of the study information | 2023/05/10 |
| Last modified on | 2024/11/04 14:13:14 |
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Basic information
Public title
Development of a comprehensive care program for muscle fatigue in postpartum women and an evaluation of its effectiveness
Acronym
Development of a comprehensive care program for muscle fatigue in postpartum women and an evaluation of its effectiveness
Scientific Title
Development of a comprehensive care program for muscle fatigue in postpartum women and an evaluation of its effectiveness
Scientific Title:Acronym
Development of a comprehensive care program for muscle fatigue in postpartum women and an evaluation of its effectiveness
Region
| Japan |
Condition
Condition
Postpartum women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of a comprehensive care program for muscle fatigue in postpartum women
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle hardness
Key secondary outcomes
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
The comprehensive care program (breathing method, stretching exercise, rub massage by family, and breastfeeding posture instruction) is implemented to postpartum women from 3 days to 2 months after childbirth
Interventions/Control_2
Control group has no intervention
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
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
Women from 3 days to 2 months postpartum
Term delivery
Key exclusion criteria
Postpartum women who are undergoing medical treatment for mental disorders
Postpartum women who are undergoing medical treatment for orthopedic diseases
Postpartum women with newborn being treated in the NICU
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Koyasu |
Organization
The University of Shiga Prefecture / Kobe University Graduate School of Health Sciences
Division name
School of Human Nursing / Department of Rehabilitation Science
Zip code
522-8533 / 654-0142
Address
2500 hassaka-cho,Hikone-city Shiga / 7-10-2Tomogaoka,Suma-ku,Kobe
TEL
0749-28-8653
koyasu.k@nurse.usp.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Koyasu |
Organization
Kobe University Graduate School of Health Sciences
Division name
Department of Rehabilitation Science
Zip code
654-0142
Address
7-10-2Tomogaoka,Suma-ku,Kobe
TEL
078-792-2555
Homepage URL
k-koyasu@people.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Graduate School of Health Sciences
Address
7-10-2Tomogaoka,Suma-ku,Kobe
Tel
078-792-2555
k-koyasu@people.kobe-u.ac.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
| 2023 | Year | 05 | Month | 10 | 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
| 2022 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 30 | Day |
Last modified on
| 2024 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057838
