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Prenatal Exercise and Cardiovascular Health (PEACH) (PEACH)

4. Mai 2018 aktualisiert von: University of Alberta, Physical Education

Exercise and Neurovascular Function During Pregnancy

Maintenance of a healthy pregnancy depends on an appropriate adaptation and responsiveness of blood vessels, to ensure appropriate blood flow to the fetus during everyday stressors. Previous work by the investigators has demonstrated that during pregnancy, the part of the nervous system responsible for cardiovascular function (the sympathetic nervous system) is hyperactive. The investigators also know that in women who develop high blood pressure during pregnancy that sympathetic nervous system activity is even higher. Yet, very little is known about why this occurs and how this might be affected.

Pregnant women are encouraged to be active, yet, less than 15% of women perform sufficient exercise to meet current guidelines. This is important because hyperactivity of the sympathetic nervous system is observed in other inactive populations and has been linked to adverse cardiovascular health outcomes including hypertension, atherosclerosis, heart attack, and stroke. Indeed, in 2011, the American Heart Association stated that inactivity was a risk factor as potent as cigarette smoking for the development of future cardiovascular disease in women.

The investigators' work and others have demonstrated that exercise during pregnancy is beneficial for both the mom and baby; however, the effect of prenatal exercise on neurovascular function is not known. If exercise is effective in controlling the increase in sympathetic activity that occurs during pregnancy, or its effects on the cardiovascular system, this may help prevent the development of high blood pressure or other cardiovascular problems during pregnancy.

Studienübersicht

Status

Unbekannt

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

The objectives of this study are to: 1) examine the impact of exercise on sympathetic and vascular function during pregnancy; 2) examine the role of endothelial function on the vascular effects of exercise during pregnancy.

Study design:

100 women (>18yrs) will be recruited in the first or second trimester (<20 wks). Women with multiple pregnancies will be excluded. Eligible women will be randomized between an aerobic exercise intervention (EXER) or no intervention (CTRL).

Initial testing will take place between 16-20 weeks of pregnancy. Following initial baseline testing, women will be randomly assigned to an exercise intervention or no intervention. Women will receive an opaque sequentially numbered envelop with their allocation. Allocation will be determined using a randomly generated allocation sequence by an individual not associated with the research study. The intervention will consist of aerobic exercise equivalent to 50-70% of heart rate reserve, 3-4 times per week until the end of the study (34-36 weeks). For initial baseline testing (16-20 weeks) and at the end of the intervention (34-36 weeks), participants will visit the laboratory twice

On Day 1, participants will complete a peak exercise test on the treadmill or bike to volitional fatigue to measures fitness and cardiovascular/cerebrovascular responses to exercise.

On Day 2 Participants will arrive fasted (12 hrs) and blood samples will be collected. Anthropometrics, personal/familial history of hypertension and pregnancy complications will be recorded. Following a standardized breakfast, participants will undergo an assessment of reflex neurovascular control including a cold pressor test, flow mediated dilation and end expiratory voluntary breath hold. Muscle sympathetic nerve activity, ultrasound (blood flow and diameter of brachial, femoral and carotid arteries), blood pressure, heart rate and respiratory variables will be measured.

OUTCOME/IMPACT

Pregnancy is a stress-test for life; with women who develop complications during pregnancy having a higher risk for cardiovascular disease later in life. Exercise is well known to prevent cardiovascular disease through improvements in endothelial function and the sympathetic nervous system. Whether this improvements is also seen in pregnancy remains to be seen.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

100

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Kanada
    • Alberta
      • Edmonton, Alberta, Kanada, T6G 2E1
        • Rekrutierung
        • Program for Pregnancy and Postpartum Health, University of Alberta
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Beschreibung

Inclusion Criteria:

  • >18 years old
  • singleton pregnancy
  • cleared to exercise by health care provider using Par Med X for Pregnancy (CSEP)

Exclusion Criteria:

  • multiple gestation
  • absolute contraindication to exercise (CSEP)
  • <18 years old
  • develops any contraindication during intervention

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Exercise Intervention
The aerobic exercise intervention will consist of a walking program at 50-70% of individual heart rate reserve. This will begin at 16-20 weeks gestation and continue 3-4 times per week until the end of the study (34-36 weeks). The duration of exercise will increase each week up to a maximum of 40 minutes (5 min warm up, 25 minutes exercise, 5 min cool down). Women will have at least one supervised exercise session per week. The investigators will also monitor other activity using questionnaires and accelerometry. This will occur at baseline (16-20 weeks), mid-intervention (24-26 weeks) and at the end (34-36 weeks).
Sonstiges: Aerobic exercise
Brisk walking 3-4 times per week for up to 40 minutes of activity.
Andere Namen:
  • Wanderprogramm
Kein Eingriff: Control Group
These women will continue regular daily activities. Activity will be monitored periodically with questionnaires and accelerometry. This will occur at baseline (16-20 weeks), mid-intervention (24-26 weeks) and at the end (34-36 weeks).

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Sympathetic Nerve Activity - cold pressor test response
Zeitfenster: 16-20 weeks and 34-36 weeks gestation
Response of the sympathetic nervous system to cold pressor test (% change in activity)
16-20 weeks and 34-36 weeks gestation

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Respiratory measures - respiratory frequency
Zeitfenster: 16-20 weeks and 34-36 weeks gestation
Breathing frequency (breaths per minute). Measured using spirometry.
16-20 weeks and 34-36 weeks gestation
Sympathetic Nerve Activity - breath hold response
Zeitfenster: 16-20 weeks and 34-36 weeks gestation
Response of the sympathetic nervous system to voluntary breath hold (% change in activity)
16-20 weeks and 34-36 weeks gestation
Respiratory measures - tidal volume
Zeitfenster: 16-20 weeks and 34-36 weeks gestation
Tidal Volume (Liters per breath). Measured using spirometry.
16-20 weeks and 34-36 weeks gestation
Respiratory measures - oxygen
Zeitfenster: 16-20 weeks and 34-36 weeks gestation
Oxygen metabolism (% oxygen used per breath). Measured using a gas analyzer.
16-20 weeks and 34-36 weeks gestation
Respiratory measures - carbon dioxide
Zeitfenster: 16-20 weeks and 34-36 weeks gestation
Carbon Dioxide production (% carbon dioxide per breath). Measured using a gas analyzer.
16-20 weeks and 34-36 weeks gestation
Respiratory measures - lung volume
Zeitfenster: 16-20 weeks and 34-36 weeks gestation
Total Lung Capacity (Liters). Measured using spirometry.
16-20 weeks and 34-36 weeks gestation
Cerebral blood flow at rest
Zeitfenster: 16-20 weeks and 34-36 weeks gestation
Brain blood flow in the middle cerebral artery at rest (cm/s). Measured using transcranial doppler ultrasound.
16-20 weeks and 34-36 weeks gestation
Cerebral autoregulation
Zeitfenster: 16-20 weeks and 34-36 weeks gestation
Brain blood flow in the middle cerebral artery in response to standing (cm/s). Measured using transcranial doppler ultrasound.
16-20 weeks and 34-36 weeks gestation
Cerebral blood flow during exercise
Zeitfenster: 16-20 weeks and 34-36 weeks gestation
Brain blood flow in the middle cerebral artery during the acute incremental peak exercise test (cm/s). Measured using transcranial doppler ultrasound.
16-20 weeks and 34-36 weeks gestation
fasted blood sample - blood volume
Zeitfenster: 16-20 weeks and 34-36 weeks gestation
Fasted blood samples (~30ml) will be analyzed for markers of blood volume (hematocrit; %)
16-20 weeks and 34-36 weeks gestation
fasted blood sample - neurotransmitters
Zeitfenster: 16-20 weeks and 34-36 weeks gestation
Fasted blood samples (~30ml) will be analyzed for sympathetic nervous system neurotransmitters (Norepinephrine, Epinephrine, Neuropeptide-Y).
16-20 weeks and 34-36 weeks gestation
fasted blood sample- inflammatory markers
Zeitfenster: 16-20 weeks and 34-36 weeks gestation
Fasted blood samples (~30ml) will be analyzed for inflammatory markers (i.e. C-Reactive Protein).
16-20 weeks and 34-36 weeks gestation
fasted blood sample- epigenetics
Zeitfenster: 16-20 weeks and 34-36 weeks gestation
Fasted blood samples (~30ml) will be analyzed for epigenetics (optional).
16-20 weeks and 34-36 weeks gestation
fasted blood sample- sex hormones
Zeitfenster: 16-20 weeks and 34-36 weeks gestation
Fasted blood samples (~30ml) will be analyzed for sex hormones (estrogen, progesterone, testosterone).
16-20 weeks and 34-36 weeks gestation
fasted blood sample- metabolic
Zeitfenster: 16-20 weeks and 34-36 weeks gestation
Fasted blood samples (~30ml) will be analyzed for metabolic parameters (i.e. glucose)
16-20 weeks and 34-36 weeks gestation
fetal outcomes- birth weight
Zeitfenster: within one month postpartum
Participants will provide the investigators with birth weight for the infant (grams).
within one month postpartum
fetal outcomes- length
Zeitfenster: within one month postpartum
Participants will provide the investigators with birth length for the infant (cm).
within one month postpartum
fetal outcomes- gestational age
Zeitfenster: within one month postpartum
Participants will provide the investigators with gestational age at delivery (weeks).
within one month postpartum
mütterliche Ergebnisse – Art der Geburt
Zeitfenster: innerhalb eines Monats nach der Geburt
Die Teilnehmer teilen den Ermittlern die Art der Entbindung (vaginal oder Kaiserschnitt) mit.
innerhalb eines Monats nach der Geburt
mütterliche Ergebnisse – Geburtskomplikationen
Zeitfenster: innerhalb eines Monats nach der Geburt
Die Teilnehmer stellen den Ermittlern Informationen zu etwaigen Geburtskomplikationen zur Verfügung.
innerhalb eines Monats nach der Geburt
mütterliche Folgen – Schwangerschaftskomplikationen
Zeitfenster: jederzeit während des Studiums
Die Teilnehmerinnen stellen den Ermittlern Informationen zu Schwangerschaftskomplikationen (Gestationsdiabetes, schwangerschaftsbedingter Bluthochdruck, Präeklampsie) zur Verfügung.
jederzeit während des Studiums
fetal outcomes- apgar score
Zeitfenster: within one month postpartum
Participants will provide the investigators with APGAR scores (out of 10) for the infant
within one month postpartum
fetal outcomes- NICU
Zeitfenster: 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
mütterliche Ergebnisse – Schwangerschaftsgewichtszunahme
Zeitfenster: innerhalb eines Monats nach der Geburt
Die Teilnehmer teilen den Untersuchern das letzte mütterliche Gewicht unmittelbar vor der Entbindung mit. Dies wird verwendet, um die Gewichtszunahme während der Schwangerschaft zu berechnen (kg; letztes Gewicht der Mutter – selbstberichtetes Gewicht vor der Schwangerschaft).
innerhalb eines Monats nach der Geburt
Endothelial Function - time to peak dilation
Zeitfenster: 16-20 weeks and 34-36 weeks gestation
The investigators will assess endothelial function using flow mediated dilation (FMD, time to maximal dilation; s)
16-20 weeks and 34-36 weeks gestation
Endothelial Function- flow mediated dilation
Zeitfenster: 16-20 weeks and 34-36 weeks gestation
The investigators will assess endothelial function using flow mediated dilation (change in diameter; mm)
16-20 weeks and 34-36 weeks gestation
Endothelial Function - shear stress
Zeitfenster: 16-20 weeks and 34-36 weeks gestation
The investigators will assess endothelial function using flow mediated dilation (shear stress; pascals).
16-20 weeks and 34-36 weeks gestation
Accelerometry
Zeitfenster: 16-20 weeks and 34-36 weeks gestation
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.
16-20 weeks and 34-36 weeks gestation
Physical Activity Questionnaire
Zeitfenster: 16-20 weeks and 34-36 weeks gestation
The participants will report physical activity using the pregnancy physical activity questionnaire (gives metabolic equivalent hours per week (MET-hr/week).
16-20 weeks and 34-36 weeks gestation
Depression rating
Zeitfenster: 16-20 weeks and 34-36 weeks gestation
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.
16-20 weeks and 34-36 weeks gestation
Sleep Quality
Zeitfenster: 16-20 weeks and 34-36 weeks gestation
Participants will report their sleep quality using the Pittsburgh Sleep Quality index. A score of 5 or more indicates poor sleep quality. The investigators will compare this score between groups before and after the intervention.
16-20 weeks and 34-36 weeks gestation
Food log
Zeitfenster: 16-20 weeks and 34-36 weeks gestation
The investigators will objectively measure nutrients in diet using a three day food record. This is completed through Food Prodigy/ Food Processor software.
16-20 weeks and 34-36 weeks gestation

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Alberta, Physical Education

Ermittler

  • Studienleiter: Rachel Skow, MSc, University of Alberta

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juli 2016

Primärer Abschluss (Voraussichtlich)

1. August 2019

Studienabschluss (Voraussichtlich)

1. Dezember 2019

Studienanmeldedaten

Zuerst eingereicht

13. Juli 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. Oktober 2016

Zuerst gepostet (Schätzen)

28. Oktober 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

7. Mai 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. Mai 2018

Zuletzt verifiziert

1. Mai 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • Pro00061045

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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