Physical Exercise Cardiovascular Adaptation Monitoring in Pregnancy (PE-CAMP Study)

NCT03748888 | Completed

• 2 other identifiers: 663830-SU-07917/WA/0414
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

The main theme of this study focuses on providing evidence of the impact of antenatal physical activity on maternal/foetal cardiovascular changes during pregnancy and maternal cardiovascular adaptations during the early postpartum period.

Conditions

Pregnancy Related; Pregnant Women; Maternal-Fetal Relations

Keywords

Cardiovascular system; Antenatal physical activity; Maternal heart rate; Foetal heart rate

Outcome Measures

Primary Outcomes (4)

• Changes in maternal cardiac output during and after pregnancy.

  Maternal cardiac output at rest, during exercise and after exercise measured in L/min would be recorded from study participants to analyse and compare potential changes inter and intra group.

  18 and 36 weeks of gestation, 12 weeks postpartum.

• Changes in maternal heart rate during and after pregnancy.

  Maternal heart rate at rest and after exercise would be recorded in beats per minute to be analysed and compared inter and intra group.

  18 and 36 weeks of gestation, 12 weeks postpartum.

• Changes in maternal heart rate variability during and after pregnancy

  Maternal heart rate variability at rest, during and after exercise would be measured by r to r interval. It would be recorded and analysed to compare inter and intra group changes.

  18 and 36 weeks of gestation, 12 weeks postpartum.

• Foetal heart rate

  Foetal heart rate baseline would be measured at rest, during and after exercise. It would be analysed and compared in between groups.

  36 weeks pregnancy

Secondary Outcomes (13)

• Changes in active pregnant women energy expenditure

  18 and 36 weeks pregnancy.

• Changes in sedentary pregnant women energy expenditure

  18 and 36 weeks pregnancy.

• Energy expenditure during the early postpartum period.

  12 weeks postpartum.

• Gestational weight gain.

  36 weeks pregnancy.

• Changes in maternal body fat percentage during pregnancy.

  18 and 36 weeks pregnancy.

Other Outcomes (7)

• Type of birth.

  2 weeks postpartum.

• Type of analgesia used during labour

  2 weeks postpartum.

• New born's Apgar score

  2 weeks postpartum.

Study Arms (2)

Exercise group

EXPERIMENTAL

An antenatal physical activity (APA) programme will be designed for participants in the exercise group.

Behavioral: Exercise group

Control Group

NO INTERVENTION

Sedentary participants.

Interventions

Exercise group BEHAVIORAL

An antenatal physical activity (APA) programme will be designed for participants in the exercise group. The APA will last for 20-24 weeks. Participants in the EG must enrol in the APA between their 12-16 weeks of gestation. The APA programme has a frequency of three times a week, which involves aerobic, strength and stretching exercises. The intensity of the APA programme is individually calculated for each participant based on their pre-pregnancy fitness level. Single sessions of the APA programme last 50-60min.

Exercise group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women with healthy pregnancy
• Aged 18-40 years
• Single pregnancy
• Pregnancy stage \<= 16 weeks' gestation at the point of consent.
• Two or fewer previous term pregnancies (as physiology can be altered by multiple pregnancies).

You may not qualify if:

• Known complications of pregnancy
• Known contraindications for physical exercise
• Known major cardiovascular or respiratory pathology
• Three or more previous term pregnancies
• Inability to communicate in English or Welsh.

Sponsors & Collaborators

• Swansea University: lead
• European Union: collaborator

Study Sites (1)

Singleton Hospital, Maternity Unit

Swansea, SA2 8QA, United Kingdom

Location

Related Publications (2)

• Carpenter RE, Emery SJ, Uzun O, Rassi D, Lewis MJ. Influence of physical exercise on baroreceptor sensitivity during pregnancy. J Matern Fetal Neonatal Med. 2017 Mar;30(5):514-519. doi: 10.1080/14767058.2016.1179275. Epub 2016 May 12.

  PMID: 27098455 RESULT

• Carpenter RE, D'Silva LA, Emery SJ, Uzun O, Rassi D, Lewis MJ. Changes in heart rate variability and QT variability during the first trimester of pregnancy. Physiol Meas. 2015 Mar;36(3):531-45. doi: 10.1088/0967-3334/36/3/531. Epub 2015 Feb 18.

  PMID: 25690105 RESULT

Study Officials

• MICHAEL J LEWIS, Prof

  Swansea University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The present study will involve two study groups. 1. Exercise group (EG). Pregnant women allocated in the EG will receive and intervention based on a supervised antenatal physical activity programme during 20-24 weeks. They must be enrolled in the study between their 12-16 weeks of gestation. 2. Control group (CG). Pregnant women allocated in CG will not receive any intervention. They will maintain standard health care during pregnancy.

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 21, 2018
• Study Start: April 26, 2018
• Primary Completion: November 30, 2021
• Study Completion: December 31, 2021
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)