Effects of Exercise During Pregnancy on Maternal and Child Health: a Randomized Clinical Trial (PAMELA)

September 27, 2021 updated by: MARLOS RODRIGUES DOMINGUES, Federal University of Pelotas
The Pamela Study is a clinical trial carried out during pregnancy to assess the potential effects of physical activity during pregnancy among previously inactive women. The trial is nested into a birth cohort of more than 4000 dyads (mother-child) and took place in Pelotas, Brazil.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Introduction World Health Organization estimates that nearly 10% of births are preterm worldwide. In the city of Pelotas, based on previous population studies, the preterm birth rate is increasing (6.3% to 14.7% from 1982 to 2004). Preterm birth (PB) is a major public health issue as it is associated to most cases of neonatal deaths and its consequences are linked to later health outcomes.

One of the strongest predictors of PB is gestational hypertension (or eclampsia). PB risk and gestational hypertension may be altered by maternal behavior, such as leisure-time physical activity (LTPA), and overall maternal health influences the likelihood of both outcomes occurring. Biological plausibility lies on the fact that hypertension conditions are potentially influenced by LTPA directly or indirectly (as in the relation between excessive gestational weight gain and physical activity). Also, there is evidence that mental health plays a role in the determination of PB and, although biased by cross-sectional nature of studies, literature shows that physical activity may influence positively psychological aspects during pregnancy.

In Brazil less than 20% of pregnant women are physically active during leisure. Physical activity during pregnancy is associated to several characteristics resulting in improved health profiles that could potentially decrease hypertension occurrence and consequently preterm birth rates. However, few clinical trials have been carried out to study such relationship in representative population samples and many of the available evidence are based solely on observational studies.

Although early studies on the effects of leisure-time physical activity during pregnancy were concerned about potential harmful effects to the health of the mother and the fetus, these have not been proven over time. Currently, there is growing evidence supporting the safe promotion of physical activity during pregnancy targeting benefits to maternal and child health. However, most of the scientific evidence derives from observational studies. There is an urgent need for results from well-designed experimental studies that enable a better understanding of the impact of exercise during pregnancy on various health outcomes maternal and child.

Methodology The intervention will start after the 12th and before the 20th week of gestation and will last until the end of pregnancy or when women feel uncomfortable with the exercise routine. The intervention will consist of three weekly exercise sessions. Each session will last around 60 minutes and will include aerobic exercises (treadmill or stationary cycling) and strength training (with focus on major muscle groups and pregnancy-specific exercises to help alleviate low back pain and work abdominal and pelvic floor muscles to prevent urinary incontinence). Workouts will be guided and supervised by physical education professionals previously trained. The intensity of the exercises will be set according to woman's fitness level and will be altered according to the progress of pregnancy based on the perceived effort. All exercise sessions will take place at the School of Physical Education from the Federal University of Pelotas.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
639

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Pelotas, Rio Grande Do Sul, Brazil, 96055-630
        • Physical Education School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant women who are at least in their 20th week of gestation, living in the city of Pelotas (Brazil), whose deliveries are due to 2015 and belonging to the 2015 Birth Cohort.

Exclusion Criteria:

  • Hypertension
  • Diabetes
  • Preterm birth history
  • Miscarriage history
  • Heart disease
  • In vitro fertilization
  • Twin pregnancy
  • Persistent bleeding
  • Body mass index above 35kg/m2
  • Heavy smokers (above 20 cigarettes/day)
  • Active women (>150 min/week of physical activity).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Lifestyle intervention
Physical Exercise / Physical Activity. Exercise intervention, three weekly sessions. Each session will last around 60 minutes and will include aerobic exercises (treadmill or stationary cycling) and strength training (with focus on major muscle groups and pregnancy-specific exercises to help alleviate low back pain and work abdominal and pelvic floor muscles to prevent urinary incontinence).
Behavioral: Physical Exercise / Physical Activity
Lifestyle intervention Exercise intervention, three weekly sessions. Each session will last around 60 minutes and will include aerobic exercises (treadmill or stationary cycling) and strength training (with focus on major muscle groups and pregnancy-specific exercises to help alleviate low back pain and work abdominal and pelvic floor muscles to prevent urinary incontinence).
No Intervention: Control Group
A group of eligible women, twice as large as the intervention group, will not receive the exercise intervention but will be followed-up equally to compare outcomes in the future.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prematurity
Time Frame: Women will be interviewed at hospital soon after birth (up to 2 days after delivering)
By the end of the intervention, after birth, the gestational age of each child will be measured to assess the preterm birth rate.
Women will be interviewed at hospital soon after birth (up to 2 days after delivering)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maternal post-partum depression
Time Frame: 3 months after the end of intervention
A follow-up study will be carried out to assess post-partum maternal depression, comparing intervention and control women.
3 months after the end of intervention
Child's development
Time Frame: Children will be followed-up and evaluated by the ages of 3, 12 and 24 months of age
During the follow-up visits that will take place in the early years of childhood, children from mothers enrolled in the intervention/control groups will be compared with neurodevelopment screening tools.
Children will be followed-up and evaluated by the ages of 3, 12 and 24 months of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of Pelotas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PAMELA-649.244
  • Wellcome Trust - 522.064 (Other Grant/Funding Number: Wellcome Trust)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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