Motor ActivityNCT00503672
Assessment of Activity in Pregnancy Using an Actigraph
An observational study of Motor Activity and Pregnancy, run by University of California, Irvine at 2 sites in United States.
Trial summary
We would like to quantify the amount and type of activity a typical pregnant woman engages in and then compare the pregnancy outcomes of women with varying activity levels. To do this, we will have women wear a device known as an accelerometer (that records activity by measuring changes in voltage levels) at certain… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Motor Activity, Pregnancy
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2007to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant Women
Who may be able to join
- Nulliparous
- First trimester (11-14w)
- No medical contraindications to normal activity
Who cannot join
- Chronic medical conditions that require restricted activity (cardiac disease, severe asthma, etc)
- Known fetal anomalies
- Morbid obesity (BMI > 39)
- Maternal age less than 18 years
- Inability to comply with instructions
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Long Beach Memorial Medical Center, Miller Children's Hospital
Long Beach, California, 90806
University of California, Irvine
Orange, California, 92868
About this study
We would like to quantify the amount and type of activity a typical pregnant woman engages in and then compare the pregnancy outcomes of women with varying activity levels. To do this, we will have women wear a device known as an accelerometer (that records activity by measuring changes in voltage levels) at certain times in their pregnancies.
Read the detailed description
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.
- Conditions
- Motor Activity, Pregnancy
- Keywords
- Motor Activity, Pregnancy, Accelerometer
- Medical subject headings
- Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Actigraphy data points
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.
Measured: The periods for wear have been selected such that they coincide with visits for routine prenatal screening.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionAug 2010
- Study completionSep 2010
Why it stopped: Data from the Actigraph devices could no longer be read/analyzed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor ActivityStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah A. Wing, University of California, Irvine
- Investigators
- Deborah A Wing, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00503672
- Sponsor's protocol ID
- 2006-5343
- Status last verified
- Nov 2017
- First submitted
- 18 Jul 2007
- Last updated
- 8 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Activity in Pregnancy Using an Actigraph
- ClinicalTrials.gov ID
- NCT00503672
- Acronym / sponsor ID
- 2006-5343
- Conditions
- Motor Activity, Pregnancy
- Keywords
- Motor Activity, Pregnancy, Accelerometer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Data from the Actigraph devices could no longer be read/analyzed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Jul 2007 (actual)
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 19 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We would like to quantify the amount and type of activity a typical pregnant woman engages in and then compare the pregnancy outcomes of women with varying activity levels. To do this, we will have women wear a device known as an accelerometer (that records activity by measuring changes in voltage levels) at certain times in their pregnancies.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant Women
Key inclusion criteria (3 listed)
- Nulliparous
- First trimester (11-14w)
- No medical contraindications to normal activity
Key exclusion criteria (5 listed)
- Chronic medical conditions that require restricted activity (cardiac disease, severe asthma, etc)
- Known fetal anomalies
- Morbid obesity (BMI > 39)
- Maternal age less than 18 years
- Inability to comply with instructions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah A Wing, MD principal investigator
University of California, Irvine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Motor Activity and Pregnancy, run by University of California, Irvine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Actigraphy data points (time frame: The periods for wear have been selected such that they coincide with visits for routine prenatal screening.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2017.