- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02557893
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
134
Phase
- 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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Resistance exercise
Resistance exercise involved 12 weeks of weight lifting 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.
|
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.
|
Bimonthly pregnancy education classes
|
What is the study measuring?
Primary Outcome Measures
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
Investigators
- 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
- 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.
- 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.
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
April 1, 2006
Primary Completion (Actual)
October 1, 2007
Study Completion (Actual)
October 1, 2007
Study Registration Dates
First Submitted
September 9, 2015
First Submitted That Met QC Criteria
September 22, 2015
First Posted (Estimate)
September 23, 2015
Study Record Updates
Last Update Posted (Estimate)
September 23, 2015
Last Update Submitted That Met QC Criteria
September 22, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Other Study ID 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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