Effects of Resistance Exercise During Pregnancy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Exercise on Back Pain in Pregnancy

Conditions
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Pregnancy

Intervention / Treatment
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* Behavioral: Resistance exercise
* Other: Education
* Other: Wait list


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resistance exercise<br>Resistance exercise involved 12 weeks of weight lifting exercise | Behavioral: Resistance exercise<br>* Resistance exercise involved 12-weeks of strength training twice per week<br>|
| Sham Comparator: Wait list<br>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<br>* 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.<br>|
| Placebo Comparator: Pregnancy education<br>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<br>* Bimonthly pregnancy education classes<br>|

What is the study measuring?
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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. | 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. | 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. | 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 |