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Completed

NCT Number: NCT02557893

Effects of Resistance Exercise During 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.

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Key information

Conditions

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Resistance exercise

Behavioral

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

Education

Other

Bimonthly pregnancy education classes

wait list

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Georgia

Other

Registry information

Official study title

Effects of Exercise on Back Pain in Pregnancy

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Sep 23, 2015
Registry last updated
Sep 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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