Assessment of Activity in Pregnancy Using an Actigraph
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|ClinicalTrials.gov Identifier: NCT00503672|
Recruitment Status : Withdrawn (Data from the Actigraph devices could no longer be read/analyzed)
First Posted : July 19, 2007
Last Update Posted : November 8, 2017
|Condition or disease|
|Motor Activity Pregnancy|
General findings that have consistently been demonstrated in the literature are that activity tends to decreased during pregnancy from pre-pregnancy levels and that activity in the third trimester is less than in the first trimester. In non-pregnant patients, increase in physical activity and exercise has been associated with improved mood and self-esteem. Although the data in pregnancy is limited, available studies do suggest that inactivity is associated with worse mood. Regular physical activity is not detrimental in low-risk patients and in fact may be beneficial.
Bed rest or activity restrictions are commonly employed interventions for women with a variety of obstetric complications such as preterm contractions, vaginal bleeding, and fetal growth restriction. There is no compelling data to support bed rest as an effective therapeutic modality. There has been some data that occupational work can increase the risk of preterm birth, but other studies have not demonstrated an effect.5 Furthermore, prolonged bedrest can have detrimental effects such as muscle weakness and increased thromboembolic risk, as well as negatively impact familial relations.
The use of the accelerometer is an attempt to objectively quantify physical activity in pregnancy. The accelerometer assesses activity by measuring voltages, and can thus provide information on the intensity of activity. An additional advantage is that it can be worn on the wrist or ankle, whereas pedometers need to be worn on the waist for maximal accuracy which limits their use in pregnant women. This novel study would contribute to the existing literature on pregnancy activity that consists primarily of survey/subjective data to determine what correlation, if any, exists between activity and pregnancy outcome. Secondarily, the study will survey its participants to see if we can corroborate previous studies that have demonstrated a relationship between activity level and patients' moods.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Assessment of Activity in Pregnancy Using an Actigraph|
|Actual Study Start Date :||July 2007|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||September 2010|
- Actigraphy data points [ Time Frame: The periods for wear have been selected such that they coincide with visits for routine prenatal screening. ]This is an observational study whose primary objective is to obtain an estimate of the amount of activity that patients engage in during a pregnancy, divided among low, moderate, and high intensity levels.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00503672
|United States, California|
|Long Beach Memorial Medical Center, Miller Children's Hospital|
|Long Beach, California, United States, 90806|
|University of California, Irvine|
|Orange, California, United States, 92868|
|Principal Investigator:||Deborah A Wing, MD||University of California, Irvine|