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Completed

NCT Number: NCT05369247

Interval Versus Continuous Exercise During Pregnancy

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

High Intensity Interval Training

Other

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 Training

Other

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

Primary outcomes

  1. Flash Glucose Monitor; interstitial Glucose

    Time frame: 7-days

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

  2. Fetal Heart Rate

    Time frame: 3-minutes

    Measured via ultrasound pre and post exercise

  3. Fetal Umbilical Blood Flow

    Time frame: 3-minutes

    Measured Via ultrasound pre and post exercise

Secondary outcomes

  1. Maternal Heart Rate

    Time frame: 40-minutes

    Measured via heart rate monitor; Measured prior to, during, and after exercise.

  2. 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.

  3. 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.

  4. 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.

  5. Cardiovascular fitness

    Time frame: 20-minutes

    Graded exercise test to volitional fatigue.

  6. 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.

  7. 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

  8. 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

  9. Blood pressure

    Time frame: 40-min

    Measured with a finometer; Measured prior to, during, and after exercise.

  10. Cardiac Output

    Time frame: 40-min

    Measured with a finometer; Measured prior to, during, and after exercise.

  11. 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.

  12. fasted blood sample- sex hormones

    Time frame: 5-minutes

    Fasted blood samples (~30ml) will be analyzed for sex hormones (estrogen, progesterone, testosterone).

  13. 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).

  14. 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.

  15. Respiratory measures - respiratory frequency

    Time frame: 40-minutes

    Breathing frequency (breaths per minute). Measured using spirometry.

  16. Respiratory measures - tidal volume

    Time frame: 40-minutes

    Tidal Volume (Liters per breath). Measured using spirometry.

  17. Respiratory measures - oxygen

    Time frame: 40-minutes

    Oxygen metabolism (% oxygen used per breath). Measured using a gas analyzer.

  18. Respiratory measures - carbon dioxide

    Time frame: 40-minutes

    Carbon Dioxide production (% carbon dioxide per breath). Measured using a gas analyzer.

  19. Respiratory measures - lung volume

    Time frame: 40-minutes

    Total Lung Capacity (Liters). Measured using spirometry.

  20. Fetal Outcome - birth weight

    Time frame: within one month postpartum

    Participants will provide the investigators with birth weight for the infant (grams)

  21. fetal outcomes- length

    Time frame: within one month postpartum

    Participants will provide the investigators with birth length for the infant (cm)

  22. fetal outcomes- gestational age

    Time frame: within one month postpartum

    Participants will provide the investigators with gestational age at delivery (weeks)

  23. maternal outcomes- mode of delivery

    Time frame: within one month postpartum

    Participants will provide the investigators with mode of delivery (vaginal or cesarean).

  24. maternal outcomes- delivery complications

    Time frame: within one month postpartum

    Participants will provide the investigators with information regarding any delivery complications.

  25. 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).

  26. 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

  27. 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).

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 11, 2022
Registry last updated
Jan 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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