Ignite Creation Date:
2024-05-06 @ 3:29 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04652830
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2020-11-26
Brief Title:
Naprapathy Training for Postpartum DRAM Prevention
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
Randomised Controlled Trial to Assess the Benefit of Naprapathy Training for Preventing Problems From Rectus Abdominis Diastasis
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NapraDRAM
Brief Summary:
A randomised controlled trial with the aim of analysing the effectiveness of a training program intended to prevent symptoms related to DRAM in the postpartum period
Detailed Description:
Diastasis of the rectus abdominis muscles DRAM is a common condition after pregnancy and after great loss of weight Distension of linea alba is a normal process during pregnancy caused by the growing fetus as well as from hormonal changes
In the majority of cases DRAM regresses during the postpartum period and the abdomen resumes its normal function I some cases however the DRAM persists for a long period This may result in trunk instability back pain and decreased abdominal muscle strength Risk factors for persisting DRAM are multiparity high maternal age and cesarean delivery
Little is known about how DRAM affects abdominal function The lack of studies on the impact of DRAM on trunk instability and back pain has made it difficult to evaluate studies aiming at reducing the problems caused by DRAM
Conservative management including training aiming at strengthening the abdominal muscles is usually considered the first hand alternative There are however few studies on the effectiveness of training programs for the purpose of preventing DRAM
The purpose of the present trial is to evaluate the effectiveness of a specific training program during a limited period of time postpartum in women with DRAM The investigators also intend to study the changes in anatomy of linea alba during the postpartum period and explore whether the changes are affected by the training
The study will be conducted as a randomized single-blind controlled trial Women with diastasis of 3 cm will be invited The aim is to include 70 women Half of them will be randomized to a training program for 3 month and the other half will be followed as a control group
At the start of the study the line alba is examined with ultrasound The width of the diastasis is registered The laxity and thickness of line alba are also evaluated The abdominal circumference is measured at rest and under straining in different postures
At the start of the study the woman is request to rate her level of physical activity Baecke questionnaire pain self-assessed functional level DRI back pain Oswestry low back disability index urinary incontinence UDI-6 IID-7 and quality of life EQ-5D The Abdominal Trunk Function Protocol ATFP is also registered at the start
The assessors performing the ultrasound examination and physical examinations are blinded to the allocation Women allocated to the training program perform exercises with a duration of ten minutes 6 days a week They also perform 3 exercises with a duration of 60 seconds three times a day The exercises are continued for three months All women those allocated to training as well as the control group are invited to follow-up examinations 6 and 12 months after inclusion
At both follow-up examinations the abdominal wall is investigated with ultrasound the abdominal circumference is measured and the woman is requested to respond to all the questionnaires that she received at the start of the study
Analyses will focus on the effect of the training program on the width and laxity of the linea alba as well as symptoms of back pain trunk instability and incontinence
In the majority of cases DRAM regresses during the postpartum period and the abdomen resumes its normal function I some cases however the DRAM persists for a long period This may result in trunk instability back pain and decreased abdominal muscle strength Risk factors for persisting DRAM are multiparity high maternal age and cesarean delivery
Little is known about how DRAM affects abdominal function The lack of studies on the impact of DRAM on trunk instability and back pain has made it difficult to evaluate studies aiming at reducing the problems caused by DRAM
Conservative management including training aiming at strengthening the abdominal muscles is usually considered the first hand alternative There are however few studies on the effectiveness of training programs for the purpose of preventing DRAM
The purpose of the present trial is to evaluate the effectiveness of a specific training program during a limited period of time postpartum in women with DRAM The investigators also intend to study the changes in anatomy of linea alba during the postpartum period and explore whether the changes are affected by the training
The study will be conducted as a randomized single-blind controlled trial Women with diastasis of 3 cm will be invited The aim is to include 70 women Half of them will be randomized to a training program for 3 month and the other half will be followed as a control group
At the start of the study the line alba is examined with ultrasound The width of the diastasis is registered The laxity and thickness of line alba are also evaluated The abdominal circumference is measured at rest and under straining in different postures
At the start of the study the woman is request to rate her level of physical activity Baecke questionnaire pain self-assessed functional level DRI back pain Oswestry low back disability index urinary incontinence UDI-6 IID-7 and quality of life EQ-5D The Abdominal Trunk Function Protocol ATFP is also registered at the start
The assessors performing the ultrasound examination and physical examinations are blinded to the allocation Women allocated to the training program perform exercises with a duration of ten minutes 6 days a week They also perform 3 exercises with a duration of 60 seconds three times a day The exercises are continued for three months All women those allocated to training as well as the control group are invited to follow-up examinations 6 and 12 months after inclusion
At both follow-up examinations the abdominal wall is investigated with ultrasound the abdominal circumference is measured and the woman is requested to respond to all the questionnaires that she received at the start of the study
Analyses will focus on the effect of the training program on the width and laxity of the linea alba as well as symptoms of back pain trunk instability and incontinence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None