NCT04288479

Brief Summary

Pregnant women are recommended to be physically active ≥150 min/week, but \<15% of Norwegian women attain this goal. Several well-designed studies on lifestyle interventions focusing primarily on exercise training in overweight/obese pregnant women have reported disappointing outcomes with regard to maternal glycemic control, gestational weight gain and infant outcomes. Low adherence to the training program was found to be a problem; the participants did not enjoy the exercise program and had difficulties scheduling time to exercise. Pregnant women also report that they are not sure what exercises are safe during pregnancy. High intensity interval training (HIT), defined as short periods of intense activity separated by low-intensity breaks, has proved to induce superior improvements in insulin sensitivity and fitness compared with continuous moderate intensity training in individuals at increased risk for cardiometabolic diseases. Even short-term (6 weeks) HIT with brief (15-60 sec) work-bouts and a total time commitment of \<45 min per week, improves insulin sensitivity similar to that attained after 6 months of traditional endurance training. HIT is feasible and enjoyable for individuals with low fitness level and with obesity. HIT is therefore a highly potent intervention that elicits important changes in a range of clinically relevant health outcomes in reproductive-aged women. This study will investigate fetal responses to a single bout of HIT. Preliminary data of the investigators suggest that HIT does not negatively influence fetal heart rate. Others have reported that uterine and umbilical blood flow are not changed during or following acute exercise. However, no previous study has determined the acute effect of HIT on uterine blood flow and there are no studies investigating the fetal blood flow distribution in response to exercise. Since the relative distribution of blood to the fetal liver is associated with newborn adiposity, fetal blood flow distribution in response to exercise can provide insight about the effect of maternal exercise on offspring health.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at below P25 for not_applicable pregnancy

Timeline
Completed

Started Feb 2022

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

First Submitted

Initial submission to the registry

February 26, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
2 years until next milestone

Study Start

First participant enrolled

February 23, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2025

Completed
Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

3.2 years

First QC Date

February 26, 2020

Last Update Submit

May 20, 2025

Conditions

Keywords

ExerciseHigh Intensity Interval TrainingPregnancy OutcomePlacental CirculationFetal BloodHeart Rate, Fetal

Outcome Measures

Primary Outcomes (2)

  • blood flow in fetal veins

    examined by Doppler ultrasound during 30 minutes

    1 day

  • blood flow in fetal arteries

    examined by Doppler ultrasound during 30 minutes

    1 day

Secondary Outcomes (7)

  • maternal heart rate

    1 dag

  • Fetal heart rate

    1 day

  • Umbilical vein diameter

    1 day

  • Maternal systolic blood pressure

    1 day

  • Maternal diastolic blood pressure

    1 day

  • +2 more secondary outcomes

Study Arms (1)

Doing a single HIT session in gestational week 22-36

EXPERIMENTAL
Behavioral: Single high-intensity interval training session

Interventions

10 minutes warming up at low-to-moderate intensity, 8x30 seconds high intensity interval training with fetal heart rate measurement after each 30 second work-bout, 2 minutes recovery at low-to-moderate intensity. Continuous monitoring of maternal heart rate.

Also known as: HIT
Doing a single HIT session in gestational week 22-36

Eligibility Criteria

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

You may qualify if:

  • pregnant, gestational week 22-36
  • singleton fetus
  • no known diseases
  • capable of cycling on an ergometer bike

You may not qualify if:

  • hypertension
  • gestational diabetes mellitus
  • any contraindication to exercise training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept Circulation and Medical Imaging, EXCAR Exercise Lab

Trondheim, Norway

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Kjell Å Salvesen, md prof

    St Olavs Hospital, Dept of Obstetrics and Gynecology

    STUDY DIRECTOR
  • Trine Moholdt, phd

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: before-after intervention effect measurement
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2020

First Posted

February 28, 2020

Study Start

February 23, 2022

Primary Completion

April 23, 2025

Study Completion

April 23, 2025

Last Updated

May 21, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations