UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058374 |
|---|---|
| Receipt number | R000066726 |
| Scientific Title | Development of an exercise promotion program integrating self-determination theory and the Health Action Process Approach for pregnant women in the late stages of pregnancy |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/07/05 23:44:33 |
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Basic information
Public title
Development of an exercise promotion program for pregnant women in the late stages of pregnancy
Acronym
Development of a program to promote exercise during late pregnancy
Scientific Title
Development of an exercise promotion program integrating self-determination theory and the Health Action Process Approach for pregnant women in the late stages of pregnancy
Scientific Title:Acronym
Development of an exercise promotion program integrating SDT and HAPA in late pregnancy
Region
| Japan |
Condition
Condition
First-time mothers between 27 and 30 weeks of pregnancy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether a combined SDT and HAPA exercise program for pregnant women in the late stages of pregnancy leads to more autonomous motivation to exercise and increased exercise volume.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
BREQ-3 (exercise motivation scale) and MET-hours per week four weeks after exercise intervention
Key secondary outcomes
Behavioral self-efficacy, maintenance self-efficacy, and recovery self-efficacy four weeks after the exercise intervention
Impressions of the exercise program
Duration of labor, mode of delivery, and presence or absence of obstetric abnormalities after the intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
A four-week exercise program combining SDT and HAPA will be implemented. The content of the exercise program will be discussed between the researcher and the pregnant woman, and the specific details of the exercises, including the content, duration, timing, participants, and location, will be decided. The agreed-upon content will be recorded in a booklet. The exercises performed during the period and the time spent on them will be recorded in a booklet created by the researchers.At the two-week mark from the start of the exercise program, the exercise content will be reviewed by the researcher and the pregnant woman.
Interventions/Control_2
The control group will be given explanations about the types, intensity, and duration of exercise recommended for pregnant women, and will engage in exercise for four weeks. Participants will be asked to record the exercises they performed and the duration of each exercise in a booklet created by the researchers.
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
| 39 | years-old | >= |
Gender
Female
Key inclusion criteria
Ages 20 to 39
First-time mothers in their 29th to 30th week of pregnancy
Single-fetus pregnancies
Pregnancies progressing smoothly with no instructions from obstetricians to rest
Pregnant women who do not exercise
Pregnant women who will give birth at the institution participating in this study
Key exclusion criteria
History of late miscarriage
Obstetric complications (pregnancy-induced hypertension, threatened premature labor, gestational diabetes, premature rupture of membranes, low-lying placenta, placenta previa)
Incidental complications (pregnant women with underlying conditions such as heart disease or respiratory disease)
Current history of musculoskeletal disorders such as low back pain or knee pain
Abnormal fetal development
Planned cesarean section
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Eriko |
| Middle name | |
| Last name | Takeda |
Organization
1-20-1 Handayama, Higashi-ku, Hamamatsu City
Division name
Graduate School of Medicine, Nursing
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu City
TEL
053-435-2510
etakeda@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Suzuki |
Organization
Hamamatsu University School of Medicine
Division name
1-20-1 Handayama, Higashi-ku, Hamamatsu City
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu City
TEL
09099444106
Homepage URL
F22003@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee for Life Science and Medical Research
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu City
Tel
09099444106
f22003@hama-med.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
| 2025 | Year | 08 | 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
| 2025 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 07 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 05 | Day |
Last modified on
| 2025 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066726
