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ISRCTN
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ISRCTN95014448
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ClinicalTrials.gov identifier
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Public title
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Can tailored exercises in pregnancy prevent low back and pelvic girdle pain?
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Scientific title
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Can tailored exercises in pregnancy prevent low back and pelvic girdle pain? A randomised controlled trial
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Acronym
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BeST
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Serial number at source
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N/A
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Study hypothesis
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Supervised exercises adapted to pregnant women can reduce the proportion reporting low back- or pelvic girdle pain
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Lay summary
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Ethics approval
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Regional Committee for Medical and Health Research Ethics South East (REK) approved on the 21st of December 2007 (ref: 1.2007.2296)
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Study design
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Randomised controlled parallel group trial
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Countries of recruitment
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Norway
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Disease/condition/study domain
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Maternity care
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Participants - inclusion criteria
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The Norwegian public health system offers all women free health care in maternity care units (MCU) during pregnancy. We included healthy Norwegian speaking women from two MCUs in the age of 18-40.
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Participants - exclusion criteria
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1. Pregnant women carrying twins
2. Inflammatory rheumatic disorders
3. Risk factors for miscarriage
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Anticipated start date
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01/03/2008
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Anticipated end date
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31/12/2009
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use contact details below to request a patient information sheet
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Target number of participants
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260
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Interventions
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The participants in the intervention group were referred to one of two special trained physical therapists and received tailored supervised exercise in groups once a week and advice to do daily home exercise.
Attention was paid to body awareness and ergonomic advice in specific in real-life situations. The main focus, however was on specific training of the transversely oriented abdominal muscles with coactivation of the lumbar multifidus at the lumbosacral
region and stretching the hip abductors
The control group did not receive any special treatment (treatment as usual).
The total intervention was carried out between gestation weeks 20 to 36. A maximum of 16 weeks. There was no further follow-up beyond gestation week 36.
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Primary outcome measure(s)
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The proportion of women experiences pain in the pelvic girdle or lumbar spine.
Outcomes were measured at gestation weeks 24, 28, 32 and 36.
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Secondary outcome measure(s)
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1. Functional status measured with the modified Roland Morris Disability Questionnaire (0-24 scale)
2. Low back- and lumbopelvic pain measured using the VAS score (0-10 scale)
3. Health related quality of life measured with the SF-8 Health Survey
Outcomes were measured at gestation weeks 24, 28, 32 and 36.
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Sources of funding
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Norwegian Fund for Postgraduate Training in Physiotherapy (Norway)
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Trial website
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Publications
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Contact name
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Prof
Kåre Birger
Hagen
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Address
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Diakonhjemmet Hospital
POBOX 23, Vinderen
0319 Oslo
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City/town
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Oslo
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Zip/Postcode
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0319
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Country
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Norway
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Email
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k.b.hagen@medisin.uio.no
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Sponsor
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Norwegian Fund for Postgraduate Training in Physiotherapy (Norway)
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Address
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Postboks 2704 St.Hanshaugen 0131 Oslo
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City/town
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Oslo
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Zip/Postcode
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0131
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Country
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Norway
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Email
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post@fondet.fysio.no
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Date applied
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25/04/2010
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Last edited
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30/06/2010
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Date ISRCTN assigned
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30/06/2010
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