Tokyo, Aug. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058374) titled 'Development of an exercise promotion program for pregnant women in the late stages of pregnancy' on Aug. 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Open -no one is blinded
Control - No treatment
Primary Sponsor:
Institute - Hamamatsu University School of Medicine
Condition:
Condition - First-time mothers between 27 and 30 weeks of pregnancy
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
Eligibility:
Age-lower limit - 20
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 Size - 36
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 07 Month 07 Day
Anticipated trial start date - 2025 Year 07 Month 14 Day
Last follow-up date - 2026 Year 06 Month 01 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066726
Disclaimer: Curated by HT Syndication.