eRapport

Training in pregnancy (TRIP), a randomized controlled trial - short and long term effects

Prosjekt
Prosjektnummer
46062115
Ansvarlig person
Signe Nilsen Stafne
Institusjon
NTNU, ISM
Prosjektkategori
Frivillige organisasjoner 2013
Helsekategori
Metabolic and Endocrine, Musculoskeletal, Reproductive Health and Childbirth
Forskningsaktivitet
3. Prevention
Rapporter
2016 - sluttrapport
Our research group has conducted a two-armed, two-centered randomized controlled trial that have addressed the effect of training in pregnancy (TRIP-trial) in prevention of pregnancy related diseases in a general population of pregnant women. The overall objective was to provide better evidence for health promoting activities/services for women in the peripartum period. The TRIP-trial was conducted in 2007-2010 and included 855 healthy pregnant women from the areas of Trondheim and Stavanger in Norway. Women were randomized to an intervention or control group. Women in the intervention group were offered a 12-week standardized exercise program with weekly group training led by a physiotherapist and a training program to be performed twice per week at home. Women in the control group received standard antenatal care. Women were enrolled at 18-22 weeks of pregnancy. Blood samples and measurements were done with validated instruments before and after the intervention period during pregnancy (20 and 36 weeks of pregnancy) and 3 months after delivery. Another important research questions are the association between adverse environment in utero and later risk for adult disease. Thus, a follow up of the 660 women included in Trondheim and their offspring were done 18 months after birth. A questionnaire based follow-up study of mothers and their offspring 7 years after birth was recently ended (December 2016). The children are also invited to two ongoing clinical substudies: 1) To investigate the association between serum levels of vitamin A and vitamin D in the pregnant mother and bone mass and body composition (fat and lean mass) in the offspring, and 2) Maternal pre- and postnatal vitamin D levels and dental caries in the primary teeth of children by 7 years of age. One phd-thesis was defended in May 2012 with the following results: The adherence to the protocol (exercising three days per week or more at moderate to high intensity) in the intervention group was 55 %. By comparison, 10 % in the control group exercised three days per week at moderate to high intensity at follow-up (p<0.001). I) There was no difference between groups in the prevalence of gestational diabetes or level of insulin resistance. II) The prevalence of lumbopelvic pain in both groups was similar, however, less women in the intervention group were on sick leave due to lumbopelvic pain. III) The intervention group reported less urinary incontinence in late gestation, and the intervention had both a primary and secondary prevention effect. No difference was found in anal incontinence between groups. IV) The physical activity monitor SenseWearTM Pro2 Armband was found to be a valid instrument in pregnant women. One phd-student is working with data from the TRIP-trial with the aim to assess exercise and vitamin D in pregnancy and effects on childbearing women’s overall health. The phd-thesis will be defended in 2018. Another phd-student is working with data from one of the substudies to assess maternal pre- and postnatal vitamin D levels and dental caries in the primary teeth of children by 7 years of age. She will defend her thesis in 2019. We are currently applying for funding for one phd-student at the substudy of levels of vitamin A and vitamin D in the pregnant mother and bone mass and body composition (fat and lean mass) in the offspring. Five master students have used data from the TRIP-trial and are working with publishing their results. The project has a unique biobank and data from a large cohort of pregnant women (N=855) followed prospectively. There is an active research group working with data from the TRIP-trial and more publications are planned. Further, data from the TRIP-trial are included in an International Weight Management in Pregnancy IPD meta-analysis Collaborative Network (i-WIP). Healthy pregnant women are encouraged to engage in regular exercise during pregnancy to continue to derive same health benefits as in the non-pregnant state. However, as research on exercise during pregnancy is mainly based on observational studies, there has been a lack of largescale randomized controlled trials to evaluate the role of exercise during pregnancy in the prevention and treatment of pregnancy-related conditions. The TRIP-trial is the largest (N=855) randomized controlled trial (RCT) that have addressed the effect of physical activity in prevention of pregnancy related diseases in a general population of pregnant women. The training protocol followed recommendations from the Norwegian Directorate of Health and American College of Obstetricians and Gynecologists. Results from the TRIP-trial supports the general recommendations that women should engage in regular exercise during pregnancy and that thorough instructions in pelvic floor muscle training and a pelvic floor muscle training program should be included in general exercise classes for pregnant women. The importance of physical activity is highlighted in the literature, and WHO has presented a global strategy for nutrition, physical activity and health. Pregnancy is a well suited time for behaviour modification, and adherence to regular exercise is inexpensive and has several documented effects throughout life. Results from the follow-up studies will assess the short- and longterm effect of regular exercise during exercise on the offspring.
2015
Our research group has conducted a randomized controlled trial that have addressed the effect of training in pregnancy (TRIP-trial) in prevention of pregnancy related diseases in a general population of pregnant women. The overall objective is to provide better evidence for health promoting activities/services for women in the peripartum period.The importance of physical activity is highlighted in the literature, and WHO has presented a global strategy for nutrition, physical activity and health. Pregnancy is a well suited time for behaviour modification, and adherence to regular exercise is inexpensive and has several documented effects throughout life. However, today’s knowledge about effects of exercise before and during pregnancy is mainly based on results from observational studies. The TRIP-trial is the largest (N=855) randomized controlled trial (RCT) that have addressed the effect of physical activity in prevention of pregnancy related diseases in a general population of pregnant women. The women were included in weeks 18-22 of pregnancy and randomly allocated to exercise and control groups. The exercise group followed a specially designed exercise program in pregnancy, including aerobic activity and strength training 3 times a week. The training protocol followed recommendations from the Norwegian Directorate of Health and American College of Obstetricians and Gynecologists. Women in the control group received the customary information provided by their midwife or general practitioner. The RCT was performed in Trondheim and Stavanger in the period between 2007 and March 2010. A total of 855 women were included. Blood samples and measurements were done with validated instruments before and after the intervention period during pregnancy (20 and 36 weeks of pregnancy) and 3 months after delivery. The TRIP-trial addressed effects of regular exercise to prevent gestational diabetes mellitus, insulin resistance and excessive weight gain in pregnant women from a general population. Secondary outcomes were hormonal status, urinary- and anal incontinence, lumbopelvic pain and sick leave, mental health and labour. Another important research questions are the association between adverse environment in utero and later risk for adult disease. Thus, a follow up of the 660 women included in Trondheim and their offspring were done 18 months after birth. A follow-up study of mothers and their offspring 7 years after birth is ongoing.
2014
Our research group has conducted a randomized controlled trial that have addressed the effect of training in pregnancy (TRIP-trial) in prevention of pregnancy related diseases in a general population of pregnant women. The overall objective is to provide better evidence for health promoting activities/services for women in the peripartum period.The importance of physical activity is highlighted in the literature, and WHO has presented a global strategy for nutrition, physical activity and health. Pregnancy is a well suited time for behaviour modification, and adherence to regular exercise is inexpensive and has several documented effects throughout life. However, today’s knowledge about effects of exercise before and during pregnancy is mainly based on results from observational studies. The TRIP-trial is the largest (N=855) randomized controlled trial (RCT) that have addressed the effect of physical activity in prevention of pregnancy related diseases in a general population of pregnant women. The women were included in weeks 18-22 of pregnancy and randomly allocated to exercise and control groups. The exercise group followed a specially designed exercise program in pregnancy, including aerobic activity and strength training 3 times a week. The training protocol followed recommendations from the Norwegian Directorate of Health and American College of Obstetricians and Gynecologists. Women in the control group received the customary information provided by their midwife or general practitioner. The RCT was performed in Trondheim and Stavanger in the period between 2007 and March 2010. A total of 855 women were included. Blood samples and measurements were done with validated instruments before and after the intervention period during pregnancy (20 and 36 weeks of pregnancy) and 3 months after delivery. The TRIP-trial addressed effects of regular exercise to prevent gestational diabetes mellitus, insulin resistance and excessive weight gain in pregnant women from a general population. Secondary outcomes were hormonal status, urinary- and anal incontinence, lumbopelvic pain and sick leave, mental health and labour. Another important research questions are the association between adverse environment in utero and later risk for adult disease. Thus, a follow up of the 660 women included in Trondheim and their offspring were done 18 months after birth, and we have recently started a follow-up study of mothers and their offspring 7 years after birth.
2013
The importance of physical activity is highlighted in the literature, and WHO has presented a global strategy for nutrition, physical activity and health. Pregnancy is a well suited time for behaviour modification, and adherence to regular exercise is inexpensive and has several documented effects throughout life. However, today’s knowledge about effects of exercise before and during pregnancy is mainly based on results from observational studies.In the TRIP-trial we assess short and long term effects of regular exercise in the prevention and treatment of several pregnancy related diseases and complications during labour. The women were included in weeks 18-22 of pregnancy and randomly allocated to exercise and control groups. The exercise group followed a specially designed exercise program in pregnancy, including aerobic activity and strength training 3 times a week. The training protocol followed recommendations from the Norwegian Directorate of Health and American College of Obstetricians and Gynecologists. Women in the control group received the customary information provided by their midwife or general practitioner. Blood samples and measurements were done with validated instruments before and after the intervention period during pregnancy (20 and 36 weeks of pregnancy) and 3 months after delivery. Eighteen months follow up of the 350 women included in Trondheim and their offspring, has recently been finished. The TRIP-trial has addressed the effects of regular exercise on gestational diabetes mellitus, insulin resistance, urinary- and anal incontinence, lumbopelvic pain, sick leave and labour. Another important research question is the association between adverse environment in utero and later risk for adult disease. Thus, we follow mothers and their offspring 18 months after delivery and are also planning a 7 year follow up. During the TRIP-trial we collected a substantial amount of data from questionnaires and blood- and urine samples that are highly significant in the further exploration of effects of regular exercise in pregnancy. Several secondary aims were described in the original protocol. A post doctor position will ensure the completion of publications from TRIP and the planning of a seven year follow up of mothers and children.
Vitenskapelige artikler
Odsæter IH, Åsberg A, Vanky E, Mørkved S, Stafne SN, Salvesen Kå, Carlsen Sm

Hemoglobin A1c as screening for gestational diabetes mellitus in Nordic Caucasian women.

Diabetol Metab Syndr 2016;8():43. Epub 2016 jul 22

PMID: 27453735

Gustafsson MK, Stafne SN, Romundstad Pr, Mørkved S, Salvesen K, Helvik AS

The effects of an exercise programme during pregnancy on health-related quality of life in pregnant women: a Norwegian randomised controlled trial.

BJOG 2016 Jun;123(7):1152-60. Epub 2015 aug 12

PMID: 26265465

Flynn AC, Dalrymple K, Barr S, Poston L, Goff LM, Rogozinska E, van Poppel MN, Rayanagoudar G, Yeo S, Barakat Carballo R, Perales M, Bogaerts A, Cecatti JG, Dodd J, Owens J, Devlieger R, Teede H, Haakstad L, Motahari-Tabari N, Tonstad S, Luoto R, Guelfi K, Petrella E, Phelan S, Scudeller TT, Hauner H, Renault K, Sagedal LR, Stafne SN, Vinter C, Astrup A, Geiker NR, McAuliffe FM, Mol BW, Thangaratinam S,

Dietary interventions in overweight and obese pregnant women: a systematic review of the content, delivery, and outcomes of randomized controlled trials.

Nutr Rev 2016 May;74(5):312-28.

PMID: 27083868

Rogozinska E, D'Amico MI, Khan KS, Cecatti JG, Teede H, Yeo S, Vinter CA, Rayanagoudar G, Barakat R, Perales M, Dodd JM, Devlieger R, Bogaerts A, van Poppel MN, Haakstad L, Shen GX, Shub A, Luoto R, Kinnunen TI, Phelan S, Poston L, Scudeller TT, El Beltagy N, Stafne SN, Tonstad S, Geiker NR, Ruifrok AE, Mol BW, Coomarasamy A, Thangaratinam S,

Development of composite outcomes for individual patient data (IPD) meta-analysis on the effects of diet and lifestyle in pregnancy: a Delphi survey.

BJOG 2016 Jan;123(2):190-8.

PMID: 26841002

Ruifrok AE, Rogozinska E, van Poppel MN, Rayanagoudar G, Kerry S, de Groot CJ, Yeo S, Molyneaux E, Barakat Carballo R, Perales M, Bogaerts A, Cecatti JG, Surita F, Dodd J, Owens J, El Beltagy N, Devlieger R, Teede H, Harrison C, Haakstad L, Shen GX, Shub A, Motahari N, Khoury J, Tonstad S, Luoto R, Kinnunen TI, Guelfi K, Facchinetti F, Petrella E, Phelan S, Scudeller TT, Rauh K, Hauner H, Renault K, Sagedal LR, Vistad I, Stafne SN, Mørkved S, Salvesen Kå, Vinter C, Vitolo M, Astrup A, Geiker NR, McAuliffe F, Poston L, Roberts T, Riley RD, Coomarasamy A, Khan KS, Mol BW, Thangaratinam S

Erratum to: Study protocol: differential effects of diet and physical activity based interventions in pregnancy on maternal and fetal outcomes: individual patient data (IPD) meta-analysis and health economic evaluation.

Syst Rev 2015;4():101. Epub 2015 jul 30

PMID: 26272207

Hellenes OM, Vik T, Løhaugen GC, Salvesen Kå, Stafne SN, Mørkved S, Evensen KA

Regular moderate exercise during pregnancy does not have an adverse effect on the neurodevelopment of the child.

Acta Paediatr 2015 Mar;104(3):285-91. Epub 2015 feb 4

PMID: 25471255

Ruifrok Anneloes E, Rogozinska Ewelina, van Poppel Mireille N M, Rayanagoudar Girish, Kerry Sally, de Groot Christianne J M, Yeo SeonAe, Molyneaux Emma, McAuliffe Fionnuala M, Poston Lucilla, Roberts Tracy, Riley Richard D, Coomarasamy Arri, Khan Khalid, Mol Ben Willem, Thangaratinam Shakila, i-WIP (International Weight Management in Pregnancy) Collaborative Group

Study protocol: differential effects of diet and physical activity based interventions in pregnancy on maternal and fetal outcomes--individual patient data (IPD) meta-analysis and health economic evaluation.

Syst Rev 2014;3():131. Epub 2014 nov 4

PMID: 25370505

Christiansen S C, Vanky E, Klungland H, Stafne S N, Mørkved S, Salvesen K Å, Sæther M, Carlsen S M

The effect of exercise and metformin treatment on circulating free DNA in pregnancy.

Placenta 2014 Dec;35(12):989-93. Epub 2014 sep 23

PMID: 25282112

Helseth Ragnhild, Salvesen Oyvind, Stafne Signe N, Mørkved Siv, Salvesen Kjell A, Carlsen Sven M

Gestational diabetes mellitus among Nordic Caucasian women: prevalence and risk factors according to WHO and simplified IADPSG criteria.

Scand J Clin Lab Invest 2014 Oct;74(7):620-8. Epub 2014 jul 1

PMID: 24980704

Salvesen Kjell Å, Stafne Signe N, Eggebø Torbjørn M, Mørkved Siv

Does regular exercise in pregnancy influence duration of labor? A secondary analysis of a randomized controlled trial.

Acta Obstet Gynecol Scand 2014 Jan;93(1):73-9. Epub 2013 nov 7

PMID: 24102423

Saga Susan, Vinsnes Anne Guttormsen, Mørkved Siv, Norton Christine, Seim Arnfinn

Prevalence and correlates of fecal incontinence among nursing home residents: a population-based cross-sectional study.

BMC Geriatr 2013;13():87. Epub 2013 aug 30

PMID: 24119057

Lonnée-Hoffmann Risa A M, Salvesen Øyvind, Mørkved Siv, Schei Berit

What predicts improvement of sexual function after pelvic floor surgery? A follow-up study.

Acta Obstet Gynecol Scand 2013 Nov;92(11):1304-12.

PMID: 23962181

Fjørtoft Toril, Grunewaldt Kristine Hermansen, Løhaugen Gro C Christensen, Mørkved Siv, Skranes Jon, Evensen Kari Anne I

Assessment of motor behaviour in high-risk-infants at 3 months predicts motor and cognitive outcomes in 10 years old children.

Early Hum Dev 2013 Oct;89(10):787-93. Epub 2013 jul 11

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Boyle Rhianon, Hay-Smith E Jean C, Cody June D, Mørkved Siv

Pelvic Floor Muscle Training for Prevention and Treatment of Urinary and Fecal Incontinence in Antenatal and Postnatal Women: A Short Version Cochrane Review.

Neurourol Urodyn 2013 Apr 24. Epub 2013 apr 24

PMID: 23616292

Askim Torunn, Indredavik Bent, Engen Astrid, Roos Kerstin, Aas Tone, Mørkved Siv

Physiotherapy after stroke: to what extent is task-oriented practice a part of conventional treatment after hospital discharge?

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Wallenius Marianne, Salvesen Kjell Å, Daltveit Anne K, Skomsvoll Johan F

Rheumatoid arthritis and outcomes in first and subsequent births based on data from a national birth registry.

Acta Obstet Gynecol Scand 2014 Mar;93(3):302-7. Epub 2014 jan 28

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Eggebø T M, Hassan W A, Salvesen K Å, Lindtjørn E, Lees C C

Sonographic prediction of vaginal delivery in prolonged labor: a two-center study.

Ultrasound Obstet Gynecol 2014 Feb;43(2):195-201. Epub 2013 des 22

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Skråstad Ragnhild B, Eik-Nes Sturla H, Sviggum Oddvar, Johansen Ole J, Salvesen Kjell Å, Romundstad Pål R, Blaas Harm-Gerd K

A randomized controlled trial of third-trimester routine ultrasound in a non-selected population.

Acta Obstet Gynecol Scand 2013 Dec;92(12):1353-60. Epub 2013 okt 15

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Kollmann C, Ter Haar G, Doležal L, Hennerici M, Salvesen K Å, Valentin L

[In Process Citation].

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Jakobsen B, Helvik AS, Stafne SN, Wallenius M, Koksvik H

Disease activity before, during and after pregnancy in women with juvenile idiopathic arthritis.

EULAR 2013

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Deltagere
  • Signe Nilssen Stafne Postdoktorstipendiat
  • Torunn Børsting Doktorgradsstipendiat
  • Tone Natland Fagerhaug Hovedveileder
  • Miriam Katarina Gustafsson Doktorgradsstipendiat
  • Mats Peder Mosti Prosjektdeltaker
  • Astrid Kamilla Stunes Prosjektdeltaker
  • Unni Syversen Prosjektdeltaker
  • Kjell Åsmund Salvesen Medveileder, biveileder
  • Kari Anne Indredavik Evensen Prosjektdeltaker
  • Siv Mørkved Hovedveileder

eRapport er utarbeidet av Sølvi Lerfald og Reidar Thorstensen, Regionalt kompetansesenter for klinisk forskning, Helse Vest RHF, og videreutvikles av de fire RHF-ene i fellesskap, med støtte fra Helse Vest IKT

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