Effects of Resistance Exercise During Pregnancy

Pregnancy Clinical Trial

Official title:

Effects of Exercise on Back Pain in Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02557893
• Other study ID #: R01NR008131
• Status: Completed
• Phase: N/A
• First received: September 9, 2015
• Last updated: September 22, 2015
• Start date: April 2006
• Est. completion date: October 2007

Study information

• Verified date: September 2015
• Source: University of Georgia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pregnancy

Intervention

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

Other:
• Education
Bimonthly pregnancy education classes
• Wait list
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Georgia

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No