NCT02557893

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Apr 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
7.9 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

1.5 years

First QC Date

September 9, 2015

Last Update Submit

September 22, 2015

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (3)

Resistance exercise

EXPERIMENTAL

Resistance exercise involved 12 weeks of weight lifting exercise

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.

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.

Other: Education

Interventions

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

Resistance exercise

Bimonthly pregnancy education classes

Pregnancy education

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

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant and able to complete baseline testing during gestational week 21 to 25 of pregnancy.

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

MeSH Terms

Interventions

Resistance TrainingEducational StatusWaiting Lists

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaSocioeconomic FactorsPopulation CharacteristicsAppointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • Patrick O'Connor, Ph.D.

    University of Georgia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2015

First Posted

September 23, 2015

Study Start

April 1, 2006

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

September 23, 2015

Record last verified: 2015-09