NCT02948439

Brief Summary

Maintenance of a healthy pregnancy depends on an appropriate adaptation and responsiveness of blood vessels, to ensure appropriate blood flow to the fetus during everyday stressors. Previous work by the investigators has demonstrated that during pregnancy, the part of the nervous system responsible for cardiovascular function (the sympathetic nervous system) is hyperactive. The investigators also know that in women who develop high blood pressure during pregnancy that sympathetic nervous system activity is even higher. Yet, very little is known about why this occurs and how this might be affected. Pregnant women are encouraged to be active, yet, less than 15% of women perform sufficient exercise to meet current guidelines. This is important because hyperactivity of the sympathetic nervous system is observed in other inactive populations and has been linked to adverse cardiovascular health outcomes including hypertension, atherosclerosis, heart attack, and stroke. Indeed, in 2011, the American Heart Association stated that inactivity was a risk factor as potent as cigarette smoking for the development of future cardiovascular disease in women. The investigators' work and others have demonstrated that exercise during pregnancy is beneficial for both the mom and baby; however, the effect of prenatal exercise on neurovascular function is not known. If exercise is effective in controlling the increase in sympathetic activity that occurs during pregnancy, or its effects on the cardiovascular system, this may help prevent the development of high blood pressure or other cardiovascular problems during pregnancy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started May 2016

Typical duration for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 28, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

December 4, 2024

Status Verified

November 1, 2024

Enrollment Period

2.6 years

First QC Date

July 13, 2016

Last Update Submit

November 29, 2024

Conditions

Keywords

pregnancycardiovascularnervous systemexercise

Outcome Measures

Primary Outcomes (1)

  • Sympathetic Nerve Activity - cold pressor test response

    Response of the sympathetic nervous system to cold pressor test (% change in activity)

    16-20 weeks and 34-36 weeks gestation

Secondary Outcomes (32)

  • Respiratory measures - respiratory frequency

    16-20 weeks and 34-36 weeks gestation

  • Sympathetic Nerve Activity - breath hold response

    16-20 weeks and 34-36 weeks gestation

  • Respiratory measures - tidal volume

    16-20 weeks and 34-36 weeks gestation

  • Respiratory measures - oxygen

    16-20 weeks and 34-36 weeks gestation

  • Respiratory measures - carbon dioxide

    16-20 weeks and 34-36 weeks gestation

  • +27 more secondary outcomes

Study Arms (2)

Exercise Intervention

EXPERIMENTAL

The aerobic exercise intervention will consist of a walking program at 50-70% of individual heart rate reserve. This will begin at 16-20 weeks gestation and continue 3-4 times per week until the end of the study (34-36 weeks). The duration of exercise will increase each week up to a maximum of 40 minutes (5 min warm up, 25 minutes exercise, 5 min cool down). Women will have at least one supervised exercise session per week. The investigators will also monitor other activity using questionnaires and accelerometry. This will occur at baseline (16-20 weeks), mid-intervention (24-26 weeks) and at the end (34-36 weeks).

Other: Aerobic exercise

Control Group

NO INTERVENTION

These women will continue regular daily activities. Activity will be monitored periodically with questionnaires and accelerometry. This will occur at baseline (16-20 weeks), mid-intervention (24-26 weeks) and at the end (34-36 weeks).

Interventions

Brisk walking 3-4 times per week for up to 40 minutes of activity.

Also known as: walking program
Exercise Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18 years old
  • singleton pregnancy
  • cleared to exercise by health care provider using Par Med X for Pregnancy (CSEP)

You may not qualify if:

  • multiple gestation
  • absolute contraindication to exercise (CSEP)
  • \<18 years old
  • develops any contraindication during intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Program for Pregnancy and Postpartum Health, University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

Location

Related Publications (2)

  • Boparai R, Skow RJ, Farooq S, Steinback CD, Davenport MH. Prenatal exercise and cardiovascular health (PEACH) study: the remote effect of aerobic exercise training on conduit artery and resistance vessel function. Appl Physiol Nutr Metab. 2021 Dec;46(12):1459-1468. doi: 10.1139/apnm-2020-0902. Epub 2021 Jun 23.

  • Skow RJ, Fraser GM, Steinback CD, Davenport MH. Prenatal Exercise and Cardiovascular Health (PEACH) Study: Impact on Muscle Sympathetic Nerve (Re)Activity. Med Sci Sports Exerc. 2021 Jun 1;53(6):1101-1113. doi: 10.1249/MSS.0000000000002583.

MeSH Terms

Conditions

Neurologic ManifestationsMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Nervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Rachel Skow, MSc

    University of Alberta

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2016

First Posted

October 28, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2018

Study Completion

February 1, 2019

Last Updated

December 4, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations