Pregnancy RelatedNCT05369247
Interval Versus Continuous Exercise During Pregnancy
A study testing High intensity Interval Training and Moderate Intensity Continuous Training in people with Pregnancy Related and Glucose, Low Blood, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Glucose, Low Blood, Fetal Heart Rate or Rhythm Abnormality Affecting Fetus
- What is being tested?
- High intensity Interval Training and Moderate Intensity Continuous Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2020to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pregnancy Related, Glucose, Low Blood, Fetal Heart Rate or Rhythm Abnormality Affecting Fetus, Fetal Blood Flow
- Being tested
- High intensity Interval Training, Moderate Intensity Continuous Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity Interval TrainingOther
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).
Moderate Intensity Continuous TrainingOther
The MICT protocol consisted of 30-minutes of moderate intensity cycling (i.e., 64 - 76% HRmax).
| Study group | Role | What they receive |
|---|---|---|
| 1st Exercise session | Experimental | Participants completed either the HIIT or MICT session. Receives: Other: High intensity Interval Training; Other: Moderate Intensity Continuous Training |
| 2nd Exercise session | Experimental | Participants completed the subsequent exercise protocol (i.e. HIIT or MICT) Receives: Other: High intensity Interval Training; Other: Moderate Intensity Continuous Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flash Glucose Monitor; interstitial Glucose
Measured by a Flash Glucose monitor inserted onto the back of the left tricep
Measured: 7-days
Fetal Heart Rate
Measured via ultrasound pre and post exercise
Measured: 3-minutes
Fetal Umbilical Blood Flow
Measured Via ultrasound pre and post exercise
Measured: 3-minutes
Secondary outcomes (27)
Maternal Heart Rate
Measured via heart rate monitor; Measured prior to, during, and after exercise.
Measured: 40-minutes
Accelerometer
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.
Measured: 7-days
Food Log
The investigators will objectively measure nutrients in diet using a seven day food record. This is completed through Food Prodigy/ Food Processor software.
Measured: 7-days
Perceived rating of perceived exertion
Borg Scale; Ratings from 6 - 20; Rating of six is minimal perceived exertion and rating of 20 is maximal perceived exertion.
Measured: 40-minutes
Cardiovascular fitness
Graded exercise test to volitional fatigue.
Measured: 20-minutes
Cerebral Blood Flow of Posterior cerebral artery
Measured using a trans cranial doppler ultrasound. Measured prior to, during, and after exercise.
Measured: 40-min
Sleep Quality
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
Measured: 7-days
Rating of Perceived Enjoyment (1-10 Scale)
Rating of 1 is the lowest level of perceived enjoyment, rating of 10 is maximal perceived enjoyment
Measured: 40-minutes
Blood pressure
Measured with a finometer; Measured prior to, during, and after exercise.
Measured: 40-min
Cardiac Output
Measured with a finometer; Measured prior to, during, and after exercise.
Measured: 40-min
Cerebral blood flow of middle cerebral artery
Measured using a trans cranial doppler ultrasound. Measured prior to, during, and after exercise.
Measured: 40-minutes
fasted blood sample- sex hormones
Fasted blood samples (~30ml) will be analyzed for sex hormones (estrogen, progesterone, testosterone).
Measured: 5-minutes
Physical Activity Questionnaire
The participants will report physical activity using the pregnancy physical activity questionnaire (gives metabolic equivalent hours per week (MET-hr/week).
Measured: 5-minutes
Depression rating
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.
Measured: 5-minutes
Respiratory measures - respiratory frequency
Breathing frequency (breaths per minute). Measured using spirometry.
Measured: 40-minutes
Respiratory measures - tidal volume
Tidal Volume (Liters per breath). Measured using spirometry.
Measured: 40-minutes
Respiratory measures - oxygen
Oxygen metabolism (% oxygen used per breath). Measured using a gas analyzer.
Measured: 40-minutes
Respiratory measures - carbon dioxide
Carbon Dioxide production (% carbon dioxide per breath). Measured using a gas analyzer.
Measured: 40-minutes
Respiratory measures - lung volume
Total Lung Capacity (Liters). Measured using spirometry.
Measured: 40-minutes
Fetal Outcome - birth weight
Participants will provide the investigators with birth weight for the infant (grams)
Measured: within one month postpartum
fetal outcomes- length
Participants will provide the investigators with birth length for the infant (cm)
Measured: within one month postpartum
fetal outcomes- gestational age
Participants will provide the investigators with gestational age at delivery (weeks)
Measured: within one month postpartum
maternal outcomes- mode of delivery
Participants will provide the investigators with mode of delivery (vaginal or cesarean).
Measured: within one month postpartum
maternal outcomes- delivery complications
Participants will provide the investigators with information regarding any delivery complications.
Measured: within one month postpartum
maternal outcomes- pregnancy complications
Participants will provide the investigators with information regarding any pregnancy complications (gestational diabetes, pregnancy induced hypertension, preeclampsia).
Measured: any time during study
fetal outcomes- NICU
Participants will provide the investigators with information regarding length (days) of admission to Neonatal Intensive Care Unit (NICU) if applicable
Measured: within one month postpartum
maternal outcomes- gestational weight gain
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).
Measured: within one month postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start1 Dec 2020
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margie H Davenport, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369247
- Sponsor's protocol ID
- Pro00103630
- Status last verified
- Oct 2022
- First submitted
- 28 Mar 2022
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37213048
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acute High-intensity Intervals Versus Moderate-intensity Continuous Cycling on Maternal and Fetal Health
- ClinicalTrials.gov ID
- NCT05369247
- Acronym / sponsor ID
- Pro00103630
- Conditions
- Pregnancy Related, Glucose, Low Blood, Fetal Heart Rate or Rhythm Abnormality Affecting Fetus, Fetal Blood Flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1st Exercise session | Experimental | Other: High intensity Interval Training, Other: Moderate Intensity Continuous TrainingParticipants completed either the HIIT or MICT session. |
| 2nd Exercise session | Experimental | Other: High intensity Interval Training, Other: Moderate Intensity Continuous TrainingParticipants completed the subsequent exercise protocol (i.e. HIIT or MICT) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intensity Interval TrainingHIIT 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 | 1st Exercise session, 2nd Exercise session |
| Moderate Intensity Continuous TrainingThe MICT protocol consisted of 30-minutes of moderate intensity cycling (i.e., 64 - 76% HRmax). | Other | 1st Exercise session, 2nd Exercise session |
Primary outcome
Flash Glucose Monitor; interstitial Glucose
Time frame: 7-days
Measured by a Flash Glucose monitor inserted onto the back of the left tricep
Fetal Heart Rate
Time frame: 3-minutes
Measured via ultrasound pre and post exercise
Fetal Umbilical Blood Flow
Time frame: 3-minutes
Measured Via ultrasound pre and post exercise
27 secondary outcomes
Maternal Heart Rate
Time frame: 40-minutes
Accelerometer
Time frame: 7-days
Food Log
Time frame: 7-days
Perceived rating of perceived exertion
Time frame: 40-minutes
Cardiovascular fitness
Time frame: 20-minutes
Cerebral Blood Flow of Posterior cerebral artery
Time frame: 40-min
Sleep Quality
Time frame: 7-days
Rating of Perceived Enjoyment (1-10 Scale)
Time frame: 40-minutes
Blood pressure
Time frame: 40-min
Cardiac Output
Time frame: 40-min
Cerebral blood flow of middle cerebral artery
Time frame: 40-minutes
fasted blood sample- sex hormones
Time frame: 5-minutes
Physical Activity Questionnaire
Time frame: 5-minutes
Depression rating
Time frame: 5-minutes
Respiratory measures - respiratory frequency
Time frame: 40-minutes
Respiratory measures - tidal volume
Time frame: 40-minutes
Respiratory measures - oxygen
Time frame: 40-minutes
Respiratory measures - carbon dioxide
Time frame: 40-minutes
Respiratory measures - lung volume
Time frame: 40-minutes
Fetal Outcome - birth weight
Time frame: within one month postpartum
fetal outcomes- length
Time frame: within one month postpartum
fetal outcomes- gestational age
Time frame: within one month postpartum
maternal outcomes- mode of delivery
Time frame: within one month postpartum
maternal outcomes- delivery complications
Time frame: within one month postpartum
maternal outcomes- pregnancy complications
Time frame: any time during study
fetal outcomes- NICU
Time frame: within one month postpartum
maternal outcomes- gestational weight gain
Time frame: within one month postpartum
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Derived from this study: PubMed 37213048Wowdzia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margie H Davenport, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity Interval Training and Moderate Intensity Continuous Training in people with Pregnancy Related and Glucose, Low Blood, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flash Glucose Monitor; interstitial Glucose (time frame: 7-days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05369247, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2023.