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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05369247
Other study ID # Pro00103630
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2020
Est. completion date December 30, 2022

Study information

Verified date October 2022
Source University of Alberta
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date December 30, 2022
Est. primary completion date December 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada University of Alberta Edmonton Alberta

Sponsors (1)

Lead Sponsor Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Flash Glucose Monitor; interstitial Glucose Measured by a Flash Glucose monitor inserted onto the back of the left tricep 7-days
Primary Fetal Heart Rate Measured via ultrasound pre and post exercise 3-minutes
Primary Fetal Umbilical Blood Flow Measured Via ultrasound pre and post exercise 3-minutes
Secondary Maternal Heart Rate Measured via heart rate monitor; Measured prior to, during, and after exercise. 40-minutes
Secondary 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. 7-days
Secondary 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. 7-days
Secondary 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. 40-minutes
Secondary Cardiovascular fitness Graded exercise test to volitional fatigue. 20-minutes
Secondary Cerebral Blood Flow of Posterior cerebral artery Measured using a trans cranial doppler ultrasound. Measured prior to, during, and after exercise. 40-min
Secondary 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 7-days
Secondary Rating of Perceived Enjoyment (1-10 Scale) Rating of 1 is the lowest level of perceived enjoyment, rating of 10 is maximal perceived enjoyment 40-minutes
Secondary Blood pressure Measured with a finometer; Measured prior to, during, and after exercise. 40-min
Secondary Cardiac Output Measured with a finometer; Measured prior to, during, and after exercise. 40-min
Secondary Cerebral blood flow of middle cerebral artery Measured using a trans cranial doppler ultrasound. Measured prior to, during, and after exercise. 40-minutes
Secondary fasted blood sample- sex hormones Fasted blood samples (~30ml) will be analyzed for sex hormones (estrogen, progesterone, testosterone). 5-minutes
Secondary Physical Activity Questionnaire The participants will report physical activity using the pregnancy physical activity questionnaire (gives metabolic equivalent hours per week (MET-hr/week). 5-minutes
Secondary 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. 5-minutes
Secondary Respiratory measures - respiratory frequency Breathing frequency (breaths per minute). Measured using spirometry. 40-minutes
Secondary Respiratory measures - tidal volume Tidal Volume (Liters per breath). Measured using spirometry. 40-minutes
Secondary Respiratory measures - oxygen Oxygen metabolism (% oxygen used per breath). Measured using a gas analyzer. 40-minutes
Secondary Respiratory measures - carbon dioxide Carbon Dioxide production (% carbon dioxide per breath). Measured using a gas analyzer. 40-minutes
Secondary Respiratory measures - lung volume Total Lung Capacity (Liters). Measured using spirometry. 40-minutes
Secondary Fetal Outcome - birth weight Participants will provide the investigators with birth weight for the infant (grams) within one month postpartum
Secondary fetal outcomes- length Participants will provide the investigators with birth length for the infant (cm) within one month postpartum
Secondary fetal outcomes- gestational age Participants will provide the investigators with gestational age at delivery (weeks) within one month postpartum
Secondary maternal outcomes- mode of delivery Participants will provide the investigators with mode of delivery (vaginal or cesarean). within one month postpartum
Secondary maternal outcomes- delivery complications Participants will provide the investigators with information regarding any delivery complications. within one month postpartum
Secondary maternal outcomes- pregnancy complications Participants will provide the investigators with information regarding any pregnancy complications (gestational diabetes, pregnancy induced hypertension, preeclampsia). any time during study
Secondary fetal outcomes- NICU Participants will provide the investigators with information regarding length (days) of admission to Neonatal Intensive Care Unit (NICU) if applicable within one month postpartum
Secondary 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). within one month postpartum
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