Exercise Training in Pregnancy for Obese Mothers

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StatusLengkap

Sponsor

Norwegian University of Science and Technology

Kolaborator

Harvard Medical School

Norwegian School of Sport Sciences

Karolinska Institutet

St. Olavs Hospital

UJI KLINIS: NCT01243554

BioSeek: nct01243554

Kata kunci

Abstrak

Observational studies demonstrate that overweight in pregnancy is a risk factor for adverse pregnancy outcomes as fetal macrosomia, prolonged labor, low Apgar score, shoulder dystocia, nerve plexus injuries, increased proportion of instrumental deliveries and perineal ruptures. There is a 2.6 fold risk for gestational diabetes mellitus (fourfold in morbidly obese women) and a recent study has shown that fetuses of obese mothers develop insulin resistance in uterus.

Main aims of this study are to assess if regular exercise in pregnancy among obese women can prevent or influence weight gain; impaired cardiac function in mother and fetus/newborn; impaired vascular function in mother; insulin resistance/sensitivity; body composition in mother and offspring; lumbopelvic pain; urinary and/or fecal incontinence; prolonged labor

Deskripsi

Women with a self-reported pre-pregnancy BMI of 28 or more will be eligible for our study. Woman are eligible if they are 18 years or older, with a singleton live fetus at an early (week 12-14) ultrasound scan. Exclusion criteria are pregnancy complications with high risk for preterm labour or diseases that could interfere with participation.

Primary outcome measure is weight increase based on weight measured at 14 weeks and immediately before labour. Assessments are done at baseline at 14 (12-18) weeks of pregnancy, and again in week 38, as well as 3 months postpartum. Some measurements are also done at other points in time. The maternal secondary outcome measurements include fasting glucose, glucose tolerance assessed by 2-h, 75 mg per-oral glucose tolerance test, insulin resistance assessed by HOMA-IR, weight, height, body composition estimated by skinfold measurements in pregnancy and by dual energy x-ray absorptiometry postpartum, blood markers, lumbopelvic pain, urin- and fecal incontinence, quality of life, psychological wellbeing, depression, and diet.

tanggal

Terakhir Diverifikasi:	05/31/2018
Pertama Dikirim:	09/05/2010
Perkiraan Pendaftaran Telah Dikirim:	11/16/2010
Pertama Diposting:	11/17/2010
Pembaruan Terakhir Dikirim:	01/23/2020
Pembaruan Terakhir Diposting:	01/27/2020
Tanggal Mulai Studi Sebenarnya:	08/31/2010
Perkiraan Tanggal Penyelesaian Utama:	05/31/2015
Perkiraan Tanggal Penyelesaian Studi:	05/31/2016

Kondisi atau penyakit

Pregnancy

Obesity

Intervensi / pengobatan

Behavioral: Exercise training

Tahap

Kelompok Lengan

Lengan	Intervensi / pengobatan
Experimental: Exercise training Supervised exercise training at the hospital during pregnancy: the women will attend at least 2 weekly sessions consisting of aerobic exercise (walking on treadmills), strength training (for upper body, back, abdomen and legs) as well as pelvic floor muscle exercises. Each session is 60 minutes and lead by a physiotherapist or experienced exercise physiologist. The women will also go through motivational interviewing sessions throughout the intervention period and are encouraged to do home exercise training in addition to the exercise at the hospital	Behavioral: Exercise training Exercise training at the hospital
No Intervention: Control Usual care as provided by the health services in Norway. The investigators will not advice the women to be inactive

Lengan

Intervensi / pengobatan

Experimental: Exercise training

Supervised exercise training at the hospital during pregnancy: the women will attend at least 2 weekly sessions consisting of aerobic exercise (walking on treadmills), strength training (for upper body, back, abdomen and legs) as well as pelvic floor muscle exercises. Each session is 60 minutes and lead by a physiotherapist or experienced exercise physiologist. The women will also go through motivational interviewing sessions throughout the intervention period and are encouraged to do home exercise training in addition to the exercise at the hospital

Behavioral: Exercise training

Exercise training at the hospital

No Intervention: Control

Usual care as provided by the health services in Norway. The investigators will not advice the women to be inactive

Kriteria kelayakan

Usia yang Layak untuk Belajar	18 Years Untuk 18 Years
Jenis Kelamin yang Layak untuk Belajar	Female
Menerima Relawan Sehat	Iya
Kriteria	Inclusion Criteria: - Pre-pregnancy body mass index of 28 or more - 18 years or more - singleton live fetus at the routine ultrasound scan Exclusion Criteria: - high risk for preterm labor or diseases that could interfere with participation

Hasil

Ukuran Hasil Utama

1. Weight gain during pregnancy [From 14 weeks pregnancy to delivery]

Measured in kg

Ukuran Hasil Sekunder

1. Fasting glucose [From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum]

Blood samples to determine the fasting glucose after an overnight fast (>10 hours)

2. Glucose tolerance [From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum]

2 hour 75 mg per-oral glucose tolerance test. Gestational diabetes is diagnosed as fasting glucose = or > 6.9 mmol/L or 2h concentration = or > 7.8 mmol/L.

3. Insulin resistance [From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum]

Homeostasis model assessment (HOMA-IR)

4. Body composition [From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum]

Skinfold measurements, done by an experienced investigator using Harpenden kaliper. At the 3 months postpartum testing, also dual energy x-ray absorptiometry (DEXA scan) will be used.

5. Blood markers for cardiovascular disease [From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum]

Inflammation markers, cytokines (leptin, resistin, adiponectin, tnf-alfa). Blood will be collected and stored for later analyses.

6. Lumbopelvic pain [From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum]

Clinical assessment (active straight leg raising, pelvic provocation test), and validated questionnaire.

7. Urin- and fecal incontinence [From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum]

Pelvic floor muscle function will be assessed by clinical assessment and by 2D and 3D ultrasound. The prevalence and severity of urin- and fecal incontinence will also be assessed by a validated questionnaire

8. Quality of life [From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum]

Validated questionnaire

9. Sleep [From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum]

Epworth sleepiness scale

10. Physical activity [From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum]

Level of physical activity will be assessed by activity registration (armbands) and by validated questionnaires

11. Diet [From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum]

Validated questionnaire: Norkost

12. Offspring birth weight, length and head circumference [At delivery]

As recorded by the hospital

13. Delivery complications [At delivery]

Vaginal or caesarean delivery, and recorded complications during the delivery

14. Markers of inflammation and metabolism in cord blood [At delivery]

Cord blood will be sampled and stored for later analysis of relevant markers of inflammation and metabolism (including resistin, leptin, adiponectin)

Exercise Training in Pregnancy for Obese Mothers

Kata kunci

rupture

fecal incontinence

diabetes mellitus

penolakan insulin

obesitas

shoulder dystocia

Abstrak

Deskripsi

tanggal

Kondisi atau penyakit

Intervensi / pengobatan

Tahap

Kelompok Lengan

Kriteria kelayakan

Hasil

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