Physical Activity Level During Pregnancy

Completed

• Conditions: Well-being; Physical Activity

• Registration Number: NCT04527731
• Lead Sponsor: University Medicine Greifswald

Brief Summary

This study examines (1) the extent and intensity of physical activity among women in different phases of their pregnancy and (2) the relationship between patterns of physical activity in pregnancy and well-being.

Detailed Description

This study examines physical activity in different phases of pregnancy using accelerometry. The recruitment of pregnant women (N=30) in the first or second trimester (until week 23) will be realized over different channels (e.g, local newspapers, facebook, and leaflets in gynecological practices, shopping centers, and nurseries).

Informed consent consists of: (i) activity recording over seven consecutive days using an accelerometer, (ii) completion of standardized questionnaires, (iii) participation in a cardiac ultrasound examination in the German Center for Cardiovascular Research (DZHK) - examination center.

Participants are asked to wear an accelerometer at daytime, and over seven consecutive days, in trimester 1 (week 9-12), trimester 2 (week 23-26), and trimester 3 (week 36-39). Women who are attended the study in the first trimester wear the device up to three time whereas those who are attended the study in their second trimester wear the device up to twice. At the end of each measurement period women are invited to fill in a self-administered questionnaire. Also they are invited to participate in a cardiac ultrasound examination. Optionally, participants may receive feedback on their physical activity measured by accelerometer as well as about results of cardiac ultrasound examination upon completion of the study.

Study Timeline

• Study Start: 2020-02-25
• Study First Submitted: 2020-06-17
• Study First Submitted QC: 2020-08-24
• Study First Posted: 2020-08-26
• Primary Completion: 2022-05-30
• Study Completion: 2022-05-30
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

Inclusion Criteria

• current pregnancy, until pregnancy week 23

Exclusion Criteria

• cognitive impairment
• insufficient language skills

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Extent and intensity of physical activity between pregnancy week 36 and 39	between pregnancy week 36 and 39	Assessement via accelerometry
Extent and intensity of physical activity between pregnancy week 23 and 26	between pregnancy week 23 and 26	Assessement via accelerometry
Extent and intensity of physical activity between pregnancy week 9 and 12	between pregnancy week 9 and 12	Assessement via accelerometry

Secondary Outcome Measures

Name	Time	Method
Left ventricular muscle mass index	Echocardiography between pregnancy week 36 and 39	Echocardiography will be done by qualified staff.
Echocardiographic global strain, in %	Echocardiography between pregnancy week 36 and 39	Echocardiography will be done by qualified staff.
Well-being	between pregnancy week 36 and 39	Assessement via self-administered questionnaire: The World Health Organisation- Five Well-Being Index (WHO-5),The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
Mother-child bond	between pregnancy week 36 and 39	assessement via self-administered questionnaire: Maternal Antenatal Attachment Scale (MAAS) consists of 19 items which are scored 1-5, with higher scores indicating higher levels of bonding.
Sociodemographics	between pregnancy week 9 and 12	age, education (\</=/\> school years), partnership, employment status

Trial Locations

Locations (1)

University Medicine Greifswald; 🇩🇪 Greifswald, Germany