Contact information
Type
Scientific
Primary contact
Prof Kåre Birger Hagen
ORCID ID
Contact details
Diakonhjemmet Hospital
POBOX 23
Vinderen
0319 Oslo
Oslo
0319
Norway
-
k.b.hagen@medisin.uio.no
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Can tailored exercises in pregnancy prevent low back and pelvic girdle pain? A randomised controlled trial
Acronym
BeST
Study hypothesis
Supervised exercises adapted to pregnant women can reduce the proportion reporting low back- or pelvic girdle pain.
Ethics approval
Regional Committee for Medical and Health Research Ethics South East (REK), 21/12/2007, ref: 1.2007.2296
Study design
Randomised controlled parallel-group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet
Condition
Maternity care
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
The proportion of women experiencing pain in the pelvic girdle or lumbar spine, measured at gestation weeks 24, 28, 32 and 36
Secondary outcome measures
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
Overall trial start date
01/03/2008
Overall trial end date
31/12/2009
Reason abandoned
Eligibility
Participant inclusion criteria
The Norwegian public health system offers all women free health care in maternity care units (MCU) during pregnancy. Healthy Norwegian speaking women aged 18-40 were included from two MCUs.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
260
Participant exclusion criteria
1. Pregnant women carrying twins
2. Inflammatory rheumatic disorders
3. Risk factors for miscarriage
Recruitment start date
01/03/2008
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Norway
Trial participating centre
Diakonhjemmet Hospital
Oslo
0319
Norway
Sponsor information
Organisation
Norwegian Fund for Postgraduate Training in Physiotherapy (Norway)
Sponsor details
Postboks 2704 St.Hanshaugen 0131 Oslo
Oslo
0131
Norway
-
post@fondet.fysio.no
Sponsor type
Government
Website
Funders
Funder type
Research organisation
Funder name
Norwegian Fund for Postgraduate Training in Physiotherapy (Norway)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available due to ethical or legal restrictions.
Intention to publish date
Participant level data
Not expected to be available
Results - basic reporting
Publication summary
2012 results in: https://www.ncbi.nlm.nih.gov/pubmed/22282770