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Physical Activity Level During Pregnancy

Fit for Two - A Pilot Study on Physical Activity Levels During Pregnancy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04527731
Acronym
Fit4Two
Enrollment
36
Registered
2020-08-26
Start date
2020-02-25
Completion date
2022-05-30
Last updated
2023-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Physical Activity, Well-being

Keywords

Pregnancy, Physical activity, Accelerometry

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.

Interventions

Participants are asked to wear an accelerometer during the day for a period of seven days.

Sponsors

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
CollaboratorOTHER
University Medicine Greifswald
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

\- current pregnancy, until pregnancy week 23

Exclusion criteria

* cognitive impairment * insufficient language skills

Design outcomes

Primary

MeasureTime frameDescription
Extent and intensity of physical activity between pregnancy week 9 and 12between pregnancy week 9 and 12Assessement via accelerometry
Extent and intensity of physical activity between pregnancy week 23 and 26between pregnancy week 23 and 26Assessement via accelerometry
Extent and intensity of physical activity between pregnancy week 36 and 39between pregnancy week 36 and 39Assessement via accelerometry

Secondary

MeasureTime frameDescription
Left ventricular muscle mass indexEchocardiography between pregnancy week 9 and 12Echocardiography will be done by qualified staff.
Well-beingbetween pregnancy week 9 and 12Assessement 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.
Echocardiographic global strain, in %Echocardiography between pregnancy week 9 and 12Echocardiography will be done by qualified staff.
Mother-child bondbetween pregnancy week 9 and 12Assessement 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.
Sociodemographicsbetween pregnancy week 9 and 12age, education (\</=/\> school years), partnership, employment status

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026