Physical Activity Level During Pregnancy

Physical Activity Clinical Trial

— Fit4Two  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04527731
• Other study ID #: BB002/20
• Status: Completed
• Start date: February 25, 2020
• Est. completion date: May 30, 2022

Study information

• Verified date: December 2023
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• current pregnancy, until pregnancy week 23

Exclusion Criteria:

• cognitive impairment
• insufficient language skills

Related Conditions & MeSH terms

• Physical Activity
• Well-being

Intervention

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

Locations

Country	Name	City	State
Germany	University Medicine Greifswald	Greifswald

Sponsors (2)

Lead Sponsor	Collaborator
University Medicine Greifswald	Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extent and intensity of physical activity between pregnancy week 9 and 12	Assessement via accelerometry	between pregnancy week 9 and 12
Primary	Extent and intensity of physical activity between pregnancy week 23 and 26	Assessement via accelerometry	between pregnancy week 23 and 26
Primary	Extent and intensity of physical activity between pregnancy week 36 and 39	Assessement via accelerometry	between pregnancy week 36 and 39
Secondary	Well-being	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.	between pregnancy week 9 and 12
Secondary	Well-being	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.	between pregnancy week 23 and 26
Secondary	Well-being	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.	between pregnancy week 36 and 39
Secondary	Mother-child bond	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.	between pregnancy week 9 and 12
Secondary	Mother-child bond	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.	between pregnancy week 23 and 26
Secondary	Mother-child bond	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.	between pregnancy week 36 and 39
Secondary	Sociodemographics	age, education (	between pregnancy week 9 and 12
Secondary	Left ventricular muscle mass index	Echocardiography will be done by qualified staff.	Echocardiography between pregnancy week 9 and 12
Secondary	Left ventricular muscle mass index	Echocardiography will be done by qualified staff.	cardiac ultrasound measurement between pregnancy week 23 and 26
Secondary	Left ventricular muscle mass index	Echocardiography will be done by qualified staff.	Echocardiography between pregnancy week 36 and 39
Secondary	Echocardiographic global strain, in %	Echocardiography will be done by qualified staff.	Echocardiography between pregnancy week 9 and 12
Secondary	Echocardiographic global strain, in %	The cardiac ultrasound examination will be conduced by qualified staff.	cardiac ultrasound measurement between pregnancy week 23 and 26
Secondary	Echocardiographic global strain, in %	Echocardiography will be done by qualified staff.	Echocardiography between pregnancy week 36 and 39