Interval Versus Continuous Exercise During Pregnancy

January 18, 2023 updated by: University of Alberta

Effects of Acute High-intensity Intervals Versus Moderate-intensity Continuous Cycling on Maternal and Fetal Health

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2R3
        • University of Alberta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1st Exercise session
Participants completed either the HIIT or MICT session.
Other: High intensity Interval Training
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).
Other: Moderate Intensity Continuous Training
The MICT protocol consisted of 30-minutes of moderate intensity cycling (i.e., 64 - 76% HRmax).
Experimental: 2nd Exercise session
Participants completed the subsequent exercise protocol (i.e. HIIT or MICT)
Other: High intensity Interval Training
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).
Other: Moderate Intensity Continuous Training
The MICT protocol consisted of 30-minutes of moderate intensity cycling (i.e., 64 - 76% HRmax).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Flash Glucose Monitor; interstitial Glucose
Time Frame: 7-days
Measured by a Flash Glucose monitor inserted onto the back of the left tricep
7-days
Fetal Heart Rate
Time Frame: 3-minutes
Measured via ultrasound pre and post exercise
3-minutes
Fetal Umbilical Blood Flow
Time Frame: 3-minutes
Measured Via ultrasound pre and post exercise
3-minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
maternal outcomes- mode of delivery
Time Frame: within one month postpartum
Participants will provide the investigators with mode of delivery (vaginal or cesarean).
within one month postpartum
maternal outcomes- delivery complications
Time Frame: within one month postpartum
Participants will provide the investigators with information regarding any delivery complications.
within one month postpartum
maternal outcomes- pregnancy complications
Time Frame: any time during study
Participants will provide the investigators with information regarding any pregnancy complications (gestational diabetes, pregnancy induced hypertension, preeclampsia).
any time during study
maternal outcomes- gestational weight gain
Time Frame: within one month postpartum
Participants will provide the investigators with the last maternal weight immediately before delivery. This will be used to calculate gestational weight gain (kg; last maternal weight - self reported pre-pregnancy weight).
within one month postpartum
Maternal Heart Rate
Time Frame: 40-minutes
Measured via heart rate monitor; Measured prior to, during, and after exercise.
40-minutes
Accelerometer
Time Frame: 7-days
The investigators will objectively measure physical activity using an accelerometer for one week. Average number of minutes per day spent in various activity levels will be determined.
7-days
Food Log
Time Frame: 7-days
The investigators will objectively measure nutrients in diet using a seven day food record. This is completed through Food Prodigy/ Food Processor software.
7-days
Perceived rating of perceived exertion
Time Frame: 40-minutes
Borg Scale; Ratings from 6 - 20; Rating of six is minimal perceived exertion and rating of 20 is maximal perceived exertion.
40-minutes
Cardiovascular fitness
Time Frame: 20-minutes
Graded exercise test to volitional fatigue.
20-minutes
Cerebral Blood Flow of Posterior cerebral artery
Time Frame: 40-min
Measured using a trans cranial doppler ultrasound. Measured prior to, during, and after exercise.
40-min
Sleep Quality
Time Frame: 7-days
The investigators will objectively measure sleep quality using an accelerometer for one week. Average number of hours of sleep per night, time spent awake after sleep onset, and number of awakenings will be determined
7-days
Rating of Perceived Enjoyment (1-10 Scale)
Time Frame: 40-minutes
Rating of 1 is the lowest level of perceived enjoyment, rating of 10 is maximal perceived enjoyment
40-minutes
Blood pressure
Time Frame: 40-min
Measured with a finometer; Measured prior to, during, and after exercise.
40-min
Cardiac Output
Time Frame: 40-min
Measured with a finometer; Measured prior to, during, and after exercise.
40-min
Cerebral blood flow of middle cerebral artery
Time Frame: 40-minutes
Measured using a trans cranial doppler ultrasound. Measured prior to, during, and after exercise.
40-minutes
fasted blood sample- sex hormones
Time Frame: 5-minutes
Fasted blood samples (~30ml) will be analyzed for sex hormones (estrogen, progesterone, testosterone).
5-minutes
Physical Activity Questionnaire
Time Frame: 5-minutes
The participants will report physical activity using the pregnancy physical activity questionnaire (gives metabolic equivalent hours per week (MET-hr/week).
5-minutes
Depression rating
Time Frame: 5-minutes
Participants will answer a 10-question questionnaire regarding their mood. A score of 10 or higher is indicative of depressive symptoms. The investigators will report the over number of women in each group who have a score of 10+ at the start and end of the intervention.
5-minutes
Respiratory measures - respiratory frequency
Time Frame: 40-minutes
Breathing frequency (breaths per minute). Measured using spirometry.
40-minutes
Respiratory measures - tidal volume
Time Frame: 40-minutes
Tidal Volume (Liters per breath). Measured using spirometry.
40-minutes
Respiratory measures - oxygen
Time Frame: 40-minutes
Oxygen metabolism (% oxygen used per breath). Measured using a gas analyzer.
40-minutes
Respiratory measures - carbon dioxide
Time Frame: 40-minutes
Carbon Dioxide production (% carbon dioxide per breath). Measured using a gas analyzer.
40-minutes
Respiratory measures - lung volume
Time Frame: 40-minutes
Total Lung Capacity (Liters). Measured using spirometry.
40-minutes
Fetal Outcome - birth weight
Time Frame: within one month postpartum
Participants will provide the investigators with birth weight for the infant (grams)
within one month postpartum
fetal outcomes- length
Time Frame: within one month postpartum
Participants will provide the investigators with birth length for the infant (cm)
within one month postpartum
fetal outcomes- gestational age
Time Frame: within one month postpartum
Participants will provide the investigators with gestational age at delivery (weeks)
within one month postpartum
fetal outcomes- NICU
Time Frame: within one month postpartum
Participants will provide the investigators with information regarding length (days) of admission to Neonatal Intensive Care Unit (NICU) if applicable
within one month postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alberta

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Margie H Davenport, PhD, University of Alberta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00103630

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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