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Prenatal Exercise and Cardiovascular Health (PEACH) (PEACH)

4 mai 2018 mis à jour par: 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.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Anticipé)

100

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2E1
        • Recrutement
        • Program for Pregnancy and Postpartum Health, University of Alberta
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Science basique
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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).
Autre: Aerobic exercise
Brisk walking 3-4 times per week for up to 40 minutes of activity.
Autres noms:
  • programme de marche
Aucune intervention: 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).

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Sympathetic Nerve Activity - cold pressor test response
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Respiratory measures - respiratory frequency
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: within one month postpartum
Participants will provide the investigators with birth weight for the infant (grams).
within one month postpartum
fetal outcomes- length
Délai: within one month postpartum
Participants will provide the investigators with birth length for the infant (cm).
within one month postpartum
fetal outcomes- gestational age
Délai: within one month postpartum
Participants will provide the investigators with gestational age at delivery (weeks).
within one month postpartum
résultats maternels - mode d'accouchement
Délai: dans un délai d'un mois après l'accouchement
Les participants fourniront aux enquêteurs le mode d'accouchement (vaginal ou césarienne).
dans un délai d'un mois après l'accouchement
résultats maternels - complications de l'accouchement
Délai: dans un délai d'un mois après l'accouchement
Les participants fourniront aux enquêteurs des informations concernant toute complication de l'accouchement.
dans un délai d'un mois après l'accouchement
résultats maternels - complications de la grossesse
Délai: à tout moment pendant l'étude
Les participants fourniront aux enquêteurs des informations concernant toute complication de la grossesse (diabète gestationnel, hypertension gravidique, prééclampsie).
à tout moment pendant l'étude
fetal outcomes- apgar score
Délai: 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
Délai: 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
résultats maternels - gain de poids gestationnel
Délai: dans un délai d'un mois après l'accouchement
Les participants fourniront aux enquêteurs le dernier poids maternel immédiatement avant l'accouchement. Cela sera utilisé pour calculer le gain de poids gestationnel (kg ; dernier poids maternel - poids autodéclaré avant la grossesse).
dans un délai d'un mois après l'accouchement
Endothelial Function - time to peak dilation
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Alberta, Physical Education

Les enquêteurs

  • Directeur d'études: Rachel Skow, MSc, University of Alberta

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juillet 2016

Achèvement primaire (Anticipé)

1 août 2019

Achèvement de l'étude (Anticipé)

1 décembre 2019

Dates d'inscription aux études

Première soumission

13 juillet 2016

Première soumission répondant aux critères de contrôle qualité

27 octobre 2016

Première publication (Estimation)

28 octobre 2016

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

7 mai 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 mai 2018

Dernière vérification

1 mai 2018

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • Pro00061045

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Non

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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