NCT05369247

Brief Summary

The objective of this randomized cross-over design was to investigate the fetal well-being and maternal glycemic response to an acute bout of aerobic high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) with pregnant individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

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

December 1, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 11, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

January 20, 2023

Status Verified

October 1, 2022

Enrollment Period

2.1 years

First QC Date

March 28, 2022

Last Update Submit

January 18, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Flash Glucose Monitor; interstitial Glucose

    Measured by a Flash Glucose monitor inserted onto the back of the left tricep

    7-days

  • Fetal Heart Rate

    Measured via ultrasound pre and post exercise

    3-minutes

  • Fetal Umbilical Blood Flow

    Measured Via ultrasound pre and post exercise

    3-minutes

Secondary Outcomes (27)

  • Maternal Heart Rate

    40-minutes

  • Accelerometer

    7-days

  • Food Log

    7-days

  • Perceived rating of perceived exertion

    40-minutes

  • Cardiovascular fitness

    20-minutes

  • +22 more secondary outcomes

Study Arms (2)

1st Exercise session

EXPERIMENTAL

Participants completed either the HIIT or MICT session.

Other: High intensity Interval TrainingOther: Moderate Intensity Continuous Training

2nd Exercise session

EXPERIMENTAL

Participants completed the subsequent exercise protocol (i.e. HIIT or MICT)

Other: High intensity Interval TrainingOther: Moderate Intensity Continuous Training

Interventions

HIIT protocol consisted of 10 one-minute intervals of high-intensity work (i.e., \> 90% HRmax) interspersed with nine one-minute intervals of self-paced active recovery (19-minutes total).

1st Exercise session2nd Exercise session

The MICT protocol consisted of 30-minutes of moderate intensity cycling (i.e., 64 - 76% HRmax).

1st Exercise session2nd Exercise session

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Carrying a singleton pregnancy (i.e. greater than or equal to 20 weeks of gestation).
  • Has access to a stationary bike
  • Located within Canada and/or within Edmonton Alberta

You may not qualify if:

  • History of smoking within the last year
  • Taking medications that may interfere with cardiovascular function.
  • High-order pregnancies, e.g. twins or above.
  • Females with absolute contraindications (as outlined by the Canadian Guidelines for Physical Activity throughout Pregnancy and the PARMed-X questionnaire)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

Location

Related Publications (1)

  • Wowdzia JB, Hazell TJ, Berg ERV, Labrecque L, Brassard P, Davenport MH. Maternal and Fetal Cardiovascular Responses to Acute High-Intensity Interval and Moderate-Intensity Continuous Training Exercise During Pregnancy: A Randomized Crossover Trial. Sports Med. 2023 Sep;53(9):1819-1833. doi: 10.1007/s40279-023-01858-5. Epub 2023 May 22.

MeSH Terms

Interventions

High-Intensity Interval Training

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Margie H Davenport, PhD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 28, 2022

First Posted

May 11, 2022

Study Start

December 1, 2020

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

January 20, 2023

Record last verified: 2022-10

Locations