PregnancyNCT02557893
Effects of Resistance Exercise During Pregnancy
A study testing Resistance exercise, Education and Wait list in people with Pregnancy, run by University of Georgia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Resistance exercise, Education and Wait list
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Oct 2007
- Phase
- Interventional
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant and able to complete baseline testing during gestational week 21 to 25 of pregnancy.
Who cannot join
- 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
Show all 17Show fewer
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy
- Being tested
- Resistance exercise, Education, Wait list
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exerciseBehavioural
Resistance exercise involved 12-weeks of strength training twice per week
EducationOther
Bimonthly pregnancy education classes
Wait listOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Resistance exercise | Experimental | Resistance exercise involved 12 weeks of weight lifting exercise Receives: Behavioral: Resistance exercise |
| Wait list | Sham comparator | 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. Receives: Other: Wait list |
| Pregnancy education | Placebo comparator | 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. Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
The intervention occurred from weeks 22 to 34 of pregnancy and the outcomes were measured the week before and after the intervention.
Measured: Change from week 21 to 35 of pregnancy
Quality of life measured using the Short Form 36 Healthy Survey.
The intervention occurred from weeks 22 to 34 of pregnancy and the outcomes were measured the week before and after the intervention.
Measured: Change from week 21 to 35 of pregnancy
Mood measured using the Profile of Mood States questionnaire.
The intervention occurred from weeks 22 to 34 of pregnancy and the outcomes were measured the week before and after the intervention.
Measured: Change from week 21 to 35 of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study startApr 2006
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick O'Connor, Ph.D., Principal investigator, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02557893
- Sponsor's protocol ID
- R01NR008131
- Status last verified
- Sep 2015
- First submitted
- 9 Sep 2015
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 21487130O'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.
PubMed 29394188
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exercise on Back Pain in Pregnancy
- ClinicalTrials.gov ID
- NCT02557893
- Acronym / sponsor ID
- R01NR008131
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 23 Sep 2015 (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.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resistance exercise | Experimental | Behavioral: Resistance exerciseResistance exercise involved 12 weeks of weight lifting exercise |
| Wait list | Sham comparator | Other: Wait listWait 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 | Placebo comparator | Other: EducationMaternity 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. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant and able to complete baseline testing during gestational week 21 to 25 of pregnancy.
Key exclusion criteria (17 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance exerciseResistance exercise involved 12-weeks of strength training twice per week | Behavioural | Resistance exercise |
| EducationBimonthly pregnancy education classes | Other | Pregnancy education |
| Wait listWait 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 |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
- Results publication: PubMed 21487130O'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.
- Derived from this study: PubMed 29394188O'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.
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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.
Patrick O'Connor, Ph.D. principal investigator
University of Georgia
Questions about this trial
What is this clinical trial studying?
A study testing Resistance exercise, Education and Wait list in people with Pregnancy, run by University of Georgia.
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 1 inclusion and 17 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: finished, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02557893, which also lists 2 linked publications.
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 23 Sep 2015.