- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01261884
Exercise in Pregnancy for Reduction of Blood Pressure in Obese Patients
Exercise Intervention in Pregnancy for Reduction of Blood Pressure in Obese Gravidas
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Hypertension affects 5-10 percent of pregnancies, and complications from hypertensive disorders of pregnancy are the third leading cause of maternal death in the United States. Hypertensive disorders of pregnancy, including preeclampsia, lead to preterm delivery, morbidity and mortality of mother, fetus, and neonate, and are a predictor of development of chronic maternal hypertension, cardiovascular disease, and renal disease. Maternal obesity is increasing dramatically in the patient population, and is an independent risk factor for hypertension and preeclampsia, increasing the risk by two- to four-fold. To date, no effective preventative measure has been found to reduce the risk of preeclampsia or hypertension in high risk pregnant patients. However, observational studies have shown that patients who exercise or who have increased physical activity before and during pregnancy have lower rates of preeclampsia, hypertension, and gestational diabetes. Exercise has been shown in numerous studies to be safe in pregnancy, and is recommended by the American College of Obstetrics and Gynecology as part of routine prenatal care. However, aerobic exercise can be viewed by patients to be difficult to perform during pregnancy, particularly when the patient is obese and at later gestations. Adherence to exercise regimens is therefore low in this patient group. Dynamic resistance training has been shown to lower mean blood pressure both acutely and long term in non-pregnant hypertensive patients, and can be performed more easily by patients with mobility issues. This intervention has not been studied in an obese pregnant population for its effects on blood pressure throughout pregnancy.
The long term goal is to develop an intervention that will reduce the barriers to exercise of obese pregnant women that will, in turn, reduce their risk of developing preeclampsia and other hypertensive disorders of pregnancy. The specific objective of this proposal is to study the effect of a structured resistance training exercise intervention on blood pressure in obese pregnant woman, who would be considered high risk for development of hypertensive disorders based on pre-pregnancy BMI. The central hypothesis is that obese pregnant patients who participate in a regular, structured resistance training exercise regimen will have a decrease in mean arterial blood pressure compared to obese pregnant patients who are strongly encouraged to do aerobic exercise (lifestyle intervention) or who participate in routine prenatal care. The investigators formulated this hypothesis, in part, based upon previous studies found in the literature performed in non-pregnant hypertensive patients. The investigators will extrapolate from the experience and methods of the collaborators, who have studied the effects of exercise on gestational diabetes.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Pennsylvania
-
Hershey, Pennsylvania, Stati Uniti, 17033
- Penn State Milton S. Hershey Medical Center
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Patient's BMI must be ≥ 30 and ≤ 40.
- Established viable singleton pregnancy <13 weeks
Exclusion Criteria:
- Multiple gestations.
- Maternal diabetes established pre-pregnancy by standard guidelines
- Congenital or acquired heart disease
- Use of antihypertensive medication
- Inability to exercise
- Restrictive lung disease
- History of shortened/incompetent cervix
- History of preterm labor
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Intervento di esercizio
|
Group C (exercise intervention) will be given the ACOG pamphlet on exercise in pregnancy, a daily activity log, a pedometer, a resistance band, and a handout on specific exercises (type and frequency) to be performed.
The study coordinator will demonstrate each exercise and then observe the participant perform each exercise to assure full understanding.
In addition to wearing the pedometer for 7 days and completing the activity log, this group will also record compliance with the exercise regimen.
|
|
Nessun intervento: Routine prenatal care
|
|
|
Sperimentale: Exercise support
|
Group B (exercise support) will be given the ACOG pamphlet on exercise in pregnancy, a daily activity log, and a pedometer.
This group will be asked to wear the pedometer for 7 consecutive days between Visits 1 and 2, and record daily activities.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Change in mean arterial blood pressure
Lasso di tempo: <13 weeks gestation-postpartum visit
|
<13 weeks gestation-postpartum visit
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
|---|---|
|
Proteinuria
|
|
|
Hypertension of pregnancy or preeclampsia
|
|
|
Gestational weight gain
|
|
|
Neonatal weight
|
|
|
Serum markers for hypertension risk
|
|
|
Activity level
|
Measured with activity logos
|
|
Number of steps per week
|
Pedometer measurement
|
|
Weight retention at postpartum visit
|
|
|
Mode of delivery
|
Vaginal versus cesarean
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 33905
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Exercise support
-
Denver Health and Hospital AuthorityNational Heart, Lung, and Blood Institute (NHLBI)CompletatoTracheotomia | Insufficienza respiratoria acuta | Ventilazione meccanicaStati Uniti
-
Medical University of South CarolinaNational Institutes of Health (NIH)ReclutamentoMalattia polmonare interstiziale | Fibrosi polmonare progressivaStati Uniti
-
Bruyère Health Research Institute.ReclutamentoPROCESSO DECILITÀ DI TRASFERIMENTO LTC-TO-HOSPITALCanada
-
Washington University School of MedicineNational Institutes of Health (NIH)Completato
-
Lisbon Institute of Global Mental Health - LIGMHColumbia UniversityReclutamentoDisturbi psicotici | Schizofrenia | Disordine bipolare | Disturbo affettivo schizoidePortogallo
-
Karolinska InstitutetReclutamentoInsufficienza respiratoria acutaSvezia
-
Medical University of South CarolinaNational Center for Advancing Translational Sciences (NCATS)CompletatoMalattia di Alzheimer | Compromissione cognitiva lieveStati Uniti
-
The University of Hong KongAttivo, non reclutanteCancro avanzato | Cure palliativeHong Kong
-
University of Alabama at BirminghamCompletatoFibrosi cisticaStati Uniti
-
Wake Forest University Health SciencesNational Center for Advancing Translational Sciences (NCATS); Atrium Health Levine...ReclutamentoAngoscia del caregiver | Tumori infantili | Supporto Sociale per i Caregiver | Bisogni socialiStati Uniti