Effects of Resistance Exercise During Pregnancy

NCT ID: NCT02557893

Last Updated: 2015-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2007-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pregnancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Resistance exercise

Resistance exercise involved 12 weeks of weight lifting exercise

Group Type EXPERIMENTAL

Resistance exercise

Intervention Type BEHAVIORAL

Resistance exercise involved 12-weeks of strength training twice per week

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.

Group Type SHAM_COMPARATOR

Wait list

Intervention Type OTHER

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.

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.

Group Type PLACEBO_COMPARATOR

Education

Intervention Type OTHER

Bimonthly pregnancy education classes

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Resistance exercise

Resistance exercise involved 12-weeks of strength training twice per week

Intervention Type BEHAVIORAL

Education

Bimonthly pregnancy education classes

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Georgia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Patrick O'Connor, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Georgia

References

Explore related publications, articles, or registry entries linked to this study.

O'Connor PJ, Poudevigne MS, Cress ME, Motl RW, Clapp JF 3rd. Safety and efficacy of supervised strength training adopted in pregnancy. J Phys Act Health. 2011 Mar;8(3):309-20. doi: 10.1123/jpah.8.3.309.

Reference Type RESULT
PMID: 21487130 (View on PubMed)

O'Connor PJ, Poudevigne MS, Johnson KE, Brito de Araujo J, Ward-Ritacco CL. Effects of Resistance Training on Fatigue-Related Domains of Quality of Life and Mood During Pregnancy: A Randomized Trial in Pregnant Women With Increased Risk of Back Pain. Psychosom Med. 2018 Apr;80(3):327-332. doi: 10.1097/PSY.0000000000000559.

Reference Type DERIVED
PMID: 29394188 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01NR008131

Identifier Type: NIH

Identifier Source: org_study_id

View Link

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Expecting Study
NCT02125149 ACTIVE_NOT_RECRUITING NA