Clinical trial NCT02557893: Effects of Resistance Exercise During Pregnancy
Official title: Effects of Exercise on Back Pain in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Lead sponsor: University of Georgia
Sponsor class: OTHER
First posted: 2015-09-23
Enrollment: 134
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: Change from week 21 to 35 of pregnancy
measure: Quality of life measured using the Short Form 36 Healthy Survey.
timeFrame: Change from week 21 to 35 of pregnancy
measure: Mood measured using the Profile of Mood States questionnaire.
timeFrame: Change from week 21 to 35 of pregnancy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Georgia
name: Patrick O'Connor, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.