- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05369247
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
---|---|
Experimental: 1st Exercise session
Participants completed either the HIIT or MICT session.
|
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).
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)
|
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).
The MICT protocol consisted of 30-minutes of moderate intensity cycling (i.e., 64 - 76% HRmax).
|
What is the study measuring?
Primary Outcome Measures
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
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
Investigators
- 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)
December 1, 2020
Primary Completion (Actual)
December 30, 2022
Study Completion (Actual)
December 30, 2022
Study Registration Dates
First Submitted
March 28, 2022
First Submitted That Met QC Criteria
May 5, 2022
First Posted (Actual)
May 11, 2022
Study Record Updates
Last Update Posted (Actual)
January 20, 2023
Last Update Submitted That Met QC Criteria
January 18, 2023
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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