Effect of Regular Exercise in Prevention of Excessive Weight Gain in Pregnancy

NCT00617149 | Completed Phase 1

• 2 other identifiers: S-05208 (REK)17804/2/KH (NSD)
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Use of variable definitions of exercise and disparate results, emphasize the need of proper randomized controlled trials examining the relationship between physical activity and weight development during pregnancy. So far, only few intervention studies aiming at weight management during pregnancy have been performed (Gray-Donald et al., 2000,Olson et al., 2004,Polley et al., 2002,Kinnunen et al., 2007). Moreover, most of these interventions have focused on how gestational weight gain may be altered through individual counselling combining diet and exercise habits, rather than supervised training. Search on PubMed revealed no randomized controlled trial where the main outcome was to investigate how the effect of supervised structured exercise may reduce the proportion of women gaining more weight than optimal. The aim of the present study is to assess whether a 12-week aerobic exercise program during pregnancy can prevent excessive gestational weight gain. Method: This is a single blind randomized controlled trial to evaluate the effects of a structured, supervised aerobic exercise program on weight gain stabilization in primiparous pregnant women. The aim is to include 100 women. Interested women eligible for the present study will be invited to a pre-test including interview and assessments at the university. The women are examined three times during the study period. The first visit is between 12 and 24 weeks of gestation, the second at week 36-38 and the last 8-12 week after delivery. The exercise program consists of supervised exercise for 60 minutes, performed at least 2 times per week, for 12-16 weeks. Compliance with the training protocol is controlled by the instructors and registrations in the womens personal training diary

Conditions

Pregnancy; Excessive Weight Gain

Keywords

exercise,; excessive weight gain during pregnancy

Outcome Measures

Primary Outcomes (1)

• Primary outcomes are overall weight gain during pregnancy and proportion of participants exceeding weight gain above IOM recommendations.

  week 36-38 of pregnancy

Secondary Outcomes (1)

• Secondary outcomes are pregnancy complications, relationship between oxygen consumption, heart rate and blood lactate concentration at submaximal work loads, infant birth weight, length of labour and complications during delivery.

  week 36-38 of gestation

Interventions

Supervised exercise for the prevention high weight gain BEHAVIORAL

Each session starts with ca 5 minutes warm up, followed by 30 minutes of aerobic activity, including cool down. This is followed by 15 minutes of strength training of the upper and lower limbs, and special focus on the deep abdominal stabilization muscles. The last 5 minutes contains stretching, relaxation and body awareness exercises. The exercise-program follows the ACOG exercise prescription, and all aerobic activities will be performed at moderate intensity (60-70% of maximal heart rate), measured by ratings of perceived exertion at 11-14 (somewhat hard) on the 6-20 Borg's rating scale. Control-participants are neither encouraged nor discouraged from exercising.

Also known as: exercise, excessive weight gain, pregnant women

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Primiparous women who have not participated in a structured exercise program, including significant amounts of walking for the past six months are eligible for the trial.

You may not qualify if:

• Severe heart disease
• Pregnancy induced hypertension
• History of more than two miscarriages
• Persistent bleeding after week 12 of gestation
• Poorly controlled thyroid disease
• Poorly controlled pre-eclampsia and/or other diseases that could interfere with participation (Artal and O'Toole, 2003)
• In addition, all women who live to far from the university to be able to attend weekly training groups will be ineligible

Sponsors & Collaborators

• Norwegian School of Sport Sciences: lead

Study Sites (1)

Norwegian School of Sport Science

Oslo, 0806, Norway

Location

Related Publications (5)

• Haakstad LAH, Bo K. The marathon of labour-Does regular exercise training influence course of labour and mode of delivery?: Secondary analysis from a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2020 Aug;251:8-13. doi: 10.1016/j.ejogrb.2020.05.014. Epub 2020 May 12.

  PMID: 32460116 DERIVED

• Woodley SJ, Lawrenson P, Boyle R, Cody JD, Morkved S, Kernohan A, Hay-Smith EJC. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. Cochrane Database Syst Rev. 2020 May 6;5(5):CD007471. doi: 10.1002/14651858.CD007471.pub4.

  PMID: 32378735 DERIVED

• Halvorsen S, Haakstad LA, Edvardsen E, Bo K. Effect of aerobic dance on cardiorespiratory fitness in pregnant women: a randomised controlled trial. Physiotherapy. 2013 Mar;99(1):42-8. doi: 10.1016/j.physio.2011.11.002. Epub 2012 Apr 3.

  PMID: 23186730 DERIVED

• Haakstad LA, Bo K. Exercise in pregnant women and birth weight: a randomized controlled trial. BMC Pregnancy Childbirth. 2011 Sep 30;11:66. doi: 10.1186/1471-2393-11-66.

  PMID: 21961534 DERIVED

• Bo K, Haakstad LA. Is pelvic floor muscle training effective when taught in a general fitness class in pregnancy? A randomised controlled trial. Physiotherapy. 2011 Sep;97(3):190-5. doi: 10.1016/j.physio.2010.08.014. Epub 2011 Feb 4.

  PMID: 21820536 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lene Haakstad, PhD student

  Norwegian School of Sport Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 4, 2008
• First Posted: February 15, 2008
• Study Start: November 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: September 18, 2009

Record last verified: 2009-09

Locations

NO (1)