Naprapathy Training for Postpartum DRAM Prevention
NapraDRAM
Randomised Controlled Trial to Assess the Benefit of Naprapathy Training for Preventing Problems from Rectus Abdominis Diastasis
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2020
CompletedFirst Posted
Study publicly available on registry
December 3, 2020
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2026
ExpectedJanuary 3, 2025
January 1, 2025
4.7 years
November 26, 2020
January 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Abdominal Trunk Function
Abdominal Trunk Function assessed with the Abdominal Trunk Function Protocol (ATFP). Six separate subscales.
One year
Secondary Outcomes (6)
Disability
One year
Urinary Incontinence
One year
Health-related Quality of Life
One year
Width of the diastasis
One year
Linea alba distortion index
One year
- +1 more secondary outcomes
Study Arms (2)
Naprapathy training
ACTIVE COMPARATORTraining program for three months
Control group
PLACEBO COMPARATORNo change of daily routines
Interventions
Active training aimed at strengthening the abdominal muscles
Eligibility Criteria
You may qualify if:
- Uni- and multiparous women 3-12 months postpartum
- Ability to understand Swedish language
- Ability participate in a three months follow-up program
- Diastasis of the rectus abdominis muscles \> 3 cm
You may not qualify if:
- Ongoing pregnancy
- Age \<18 years or \>50 years
- \< 3 months or \>12 months post partum
- History of neurologic, musculoskeletal or psychiatric disorders
- Interrectal diastasis \< 3 cm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- Hela Kvinnans Klinikcollaborator
Study Sites (1)
Hela Kvinnans Klinik
Stockholm, 116 37, Sweden
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gabriel Sandblom, Ass Prof
Karolinska Institutet
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcome assessors performing the follow-up ultrasound and clinical examination are blinded to the allocation
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research group leader
Study Record Dates
First Submitted
November 26, 2020
First Posted
December 3, 2020
Study Start
March 1, 2021
Primary Completion
October 31, 2025
Study Completion (Estimated)
October 31, 2026
Last Updated
January 3, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share