Effects of Resistance Exercise During Pregnancy

September 22, 2015 updated by: University of Georgia

Effects of Exercise on Back Pain in Pregnancy

Pregnant women at increased risk for back pain were studied during the second trimester and randomized to12-weeks of resistance exercise, education or waitlist. Several outcomes were assessed including physical function, quality of life and mood.

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

A parallel group trial was completed at a single site. Second trimester women (n=134) were randomly assigned (in blocks of 3) to 12-weeks of wait list, bi-monthly pregnancy education classes or twice weekly low-to-moderate intensity resistance training. Resistance training involved one abdominal exercise with no external load and five exercises with an external load that gradually progressed (leg extension, leg press, arm lat pull, leg curl, and lumbar extension). Several outcomes were assessed including physical function, quality of life and mood.

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.
134

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

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

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant and able to complete baseline testing during gestational week 21 to 25 of pregnancy.

Exclusion Criteria:

  • Regular resistance exercise training (≥ twice per week during the past month)
  • an orthopedic or cardiovascular limitation
  • a psychiatric disorder

  • or had in the current or a prior pregnancy any of the following:

    • two or more miscarriages
    • premature labor
    • placental previa,
    • poor fetal growth,
    • low pre-pregnancy body weight (BMI < 17.5)
    • a multiple birth pregnancy
    • pre-eclampsia
    • preterm rupture of membranes
    • uterine growth retardation
    • incompetent cervix/cerclage
    • recurrent vaginal bleeding
    • anemia or
    • diabetes.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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: Resistance exercise
Resistance exercise involved 12 weeks of weight lifting exercise
Behavioral: Resistance exercise
Resistance exercise involved 12-weeks of strength training twice per week
Sham Comparator: Wait list
Wait list participants were tested on the outcomes during their pregnancy and were eligible to participate in a post-partum supervised exercise program. The wait list participants formed a no treatment control group.
Other: Wait list
Wait list participants were tested on the outcomes during their pregnancy and were eligible to participate in a post-partum supervised exercise program. The wait list participants formed a no treatment control group.
Placebo Comparator: Pregnancy education
Maternity nurses taught six bimonthly pregnancy education classes (~20 per class) which covered several topics including information about what to expect during normal labor and delivery, common interventions during delivery (medications, induction, Cesarean delivery), parenting skills needed for baby care, breastfeeding, baby and child cardiopulmonary resuscitation, typical child development and communicating with infants. No physical activity education was included in the curriculum. The pregnancy education participants formed an attention control group.
Other: Education
Bimonthly pregnancy education classes

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
Physical function measured with physical tests such as time to make a bed, get up and down off the floor and pick up scarves from the floor.
Time Frame: Change from week 21 to 35 of pregnancy
The intervention occurred from weeks 22 to 34 of pregnancy and the outcomes were measured the week before and after the intervention.
Change from week 21 to 35 of pregnancy
Quality of life measured using the Short Form 36 Healthy Survey.
Time Frame: Change from week 21 to 35 of pregnancy
The intervention occurred from weeks 22 to 34 of pregnancy and the outcomes were measured the week before and after the intervention.
Change from week 21 to 35 of pregnancy
Mood measured using the Profile of Mood States questionnaire.
Time Frame: Change from week 21 to 35 of pregnancy
The intervention occurred from weeks 22 to 34 of pregnancy and the outcomes were measured the week before and after the intervention.
Change from week 21 to 35 of pregnancy

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.
University of Georgia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Patrick O'Connor, Ph.D., University of Georgia

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

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.
April 1, 2006

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.
October 1, 2007

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.
October 1, 2007

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).
September 9, 2015

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.
September 22, 2015

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.
September 23, 2015

Study Record Updates

Last Update Posted (Estimate)

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 23, 2015

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 22, 2015

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, 2015

More Information

Terms related to this study

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.
  • R01NR008131 (U.S. NIH Grant/Contract)

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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