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Prenatal Exercise and Cardiovascular Health (PEACH) (PEACH)

4 maj 2018 uppdaterad av: 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.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Förväntat)

100

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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).
Övrig: Aerobic exercise
Brisk walking 3-4 times per week for up to 40 minutes of activity.
Andra namn:
  • promenadprogram
Inget ingripande: 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).

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Sympathetic Nerve Activity - cold pressor test response
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Respiratory measures - respiratory frequency
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: within one month postpartum
Participants will provide the investigators with birth weight for the infant (grams).
within one month postpartum
fetal outcomes- length
Tidsram: within one month postpartum
Participants will provide the investigators with birth length for the infant (cm).
within one month postpartum
fetal outcomes- gestational age
Tidsram: within one month postpartum
Participants will provide the investigators with gestational age at delivery (weeks).
within one month postpartum
maternal utfall- förlossningssätt
Tidsram: inom en månad efter förlossningen
Deltagarna kommer att förse utredarna med förlossningssätt (vaginalt eller kejsarsnitt).
inom en månad efter förlossningen
maternal resultat- förlossningskomplikationer
Tidsram: inom en månad efter förlossningen
Deltagarna kommer att förse utredarna med information om eventuella leveranskomplikationer.
inom en månad efter förlossningen
maternal utfall- graviditetskomplikationer
Tidsram: när som helst under studietiden
Deltagarna kommer att ge utredarna information om eventuella graviditetskomplikationer (gestationsdiabetes, graviditetsinducerad hypertoni, havandeskapsförgiftning).
när som helst under studietiden
fetal outcomes- apgar score
Tidsram: 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
Tidsram: 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
moderns resultat- viktökning i graviditeten
Tidsram: inom en månad efter förlossningen
Deltagarna kommer att förse utredarna med den sista moderns vikt omedelbart före förlossningen. Detta kommer att användas för att beräkna viktökning under graviditeten (kg; moderns sista vikt - självrapporterad vikt före graviditeten).
inom en månad efter förlossningen
Endothelial Function - time to peak dilation
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Alberta, Physical Education

Utredare

  • Studierektor: Rachel Skow, MSc, University of Alberta

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juli 2016

Primärt slutförande (Förväntat)

1 augusti 2019

Avslutad studie (Förväntat)

1 december 2019

Studieregistreringsdatum

Först inskickad

13 juli 2016

Först inskickad som uppfyllde QC-kriterierna

27 oktober 2016

Första postat (Uppskatta)

28 oktober 2016

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

7 maj 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 maj 2018

Senast verifierad

1 maj 2018

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • Pro00061045

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Nej

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

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produkt tillverkad i och exporterad från U.S.A.

Nej

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