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Clinical Trials/NCT04527731
NCT04527731
Completed
Not Applicable

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

University Medicine Greifswald1 site in 1 country36 target enrollmentFebruary 25, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Physical Activity
Sponsor
University Medicine Greifswald
Enrollment
36
Locations
1
Primary Endpoint
Extent and intensity of physical activity between pregnancy week 9 and 12
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 25, 2020
End Date
May 30, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
University Medicine Greifswald
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • current pregnancy, until pregnancy week 23

Exclusion Criteria

  • cognitive impairment
  • insufficient language skills

Outcomes

Primary Outcomes

Extent and intensity of physical activity between pregnancy week 9 and 12

Time Frame: between pregnancy week 9 and 12

Assessement via accelerometry

Extent and intensity of physical activity between pregnancy week 36 and 39

Time Frame: between pregnancy week 36 and 39

Assessement via accelerometry

Extent and intensity of physical activity between pregnancy week 23 and 26

Time Frame: between pregnancy week 23 and 26

Assessement via accelerometry

Secondary Outcomes

  • Left ventricular muscle mass index(Echocardiography between pregnancy week 36 and 39)
  • Echocardiographic global strain, in %(Echocardiography between pregnancy week 36 and 39)
  • Well-being(between pregnancy week 36 and 39)
  • Mother-child bond(between pregnancy week 36 and 39)
  • Sociodemographics(between pregnancy week 9 and 12)

Study Sites (1)

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