NCT04122924

Brief Summary

Prevalence rates of diastasis recti abdominis (DRA) among postpartum women vary between 30% - 68%. It has been postulated that DRA, in addition to being a cosmetic concern for many women, may reduce low- back and pelvic stability causing low back- and pelvic girdle pain and be related to pelvic floor dysfunctions such as urinary incontinence, anal incontinence and pelvic organ prolapse. Given the limited research data, there is currently no consensus on which abdominal exercises to recommend to narrow the diastasis. The purpose of this assessor blinded parallel group randomized controlled trial (RCT) is to evaluate the effect of abdominal muscle training on inter-recti distance (IRD) and prevalence of DRA.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 9, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2022

Completed
Last Updated

March 2, 2023

Status Verified

March 1, 2023

Enrollment Period

3 years

First QC Date

October 4, 2019

Last Update Submit

March 1, 2023

Conditions

Keywords

PostpartumAbdominal Muscle TrainingExercise

Outcome Measures

Primary Outcomes (1)

  • Change in IRD assessed by 2D ultrasonography

    A portable 2D ultrasound (GE Healthcare -Logiq e R7) will be used to assess IRD inn mm at 2 cm above and 2 cm below (P. G. Mota et al., 2015a) the umbilicus during rest and crunch.

    Change from baseline IRD at 3 months

Secondary Outcomes (7)

  • Change in abdominal endurance

    Change from baseline abdominal endurance at 3 months

  • Change in abdominal strength

    Change from baseline abdominal strength at 3 months

  • Change in cross-sectional area of m. rectus abdominis

    Change from baseline cross-sectional area at 3 months

  • Change in symptoms of low back pain

    Change from baseline symptoms of low back pain at 3 months

  • Change in symptoms of pelvic girdle pain

    Change from baseline symptoms of pelvic girdle pain at 3 months

  • +2 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

A three months home-based abdominal muscle training program.

Other: Abdominal muscle training

Control Group

NO INTERVENTION

The control group will have no intervention, and will be asked not to attend any specific supervised abdominal muscle training program during the 3 months intervention period.

Interventions

The intervention starts 6-12 months postpartum and will last for three months with weekly follow-up through an exercise app. Before commencing the home-based program, women in the intervention group will have an individual session in how to perform the program with a physiotherapist. The intervention consists of a 10 min 5 days a week exercise program, including the following exercises; headlift, crunch and twisted crunch. General principles for strength training are followed: 3 sets of 8-12 contractions close to maximum. The participants will be provided with a smartphone app (Athlete Monitoring) to be reminded to exercise and to register adherence.

Intervention Group

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Primi- and multiparous women 6-12 months postpartum
  • Understand instructions given in Norwegian language
  • Willing/available to participate in a 3 months intervention period

You may not qualify if:

  • Pregnant women
  • Women \< 6 months or \> 12 months postpartum
  • Women with children with illnesses and mothers with neurological, systemic musculoskeletal diseases or psychiatric diagnoses will be excluded from participation
  • Women with adherence \< 70 % of the home-based program will be excluded for the per protocol analyzes
  • Women with specific need for pelvic floor muscle training during the 3 months intervention period will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian School of Sport Sciences, Department of Sports Medicine

Oslo, 0863, Norway

Location

Related Publications (21)

  • Rett, M. T., Braga, M., Bernardes, N., & Andrade, S. (2009). Prevalence of diastasis of the rectus abdominis muscles immediately postpartum: comparison between primiparae and multiparae. Revista Brasileira De Fisioterapia, 13(4), 275-280. doi:10.1590/s1413-35552009005000037

    BACKGROUND
  • Turan V, Colluoglu C, Turkyilmaz E, Korucuoglu U. Prevalence of diastasis recti abdominis in the population of young multiparous adults in Turkey. Ginekol Pol. 2011 Nov;82(11):817-21.

    PMID: 22384613BACKGROUND
  • Lee DG, Lee LJ, McLaughlin L. Stability, continence and breathing: the role of fascia following pregnancy and delivery. J Bodyw Mov Ther. 2008 Oct;12(4):333-48. doi: 10.1016/j.jbmt.2008.05.003. Epub 2008 Jul 1.

    PMID: 19083692BACKGROUND
  • Spitznagle TM, Leong FC, Van Dillen LR. Prevalence of diastasis recti abdominis in a urogynecological patient population. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Mar;18(3):321-8. doi: 10.1007/s00192-006-0143-5. Epub 2006 Jul 26.

    PMID: 16868659BACKGROUND
  • Venes, D., & Taber, C. (2013). Taber's cyclopedic medical dictionary (22. ed.). Philadelphia: FA Davis Co

    BACKGROUND
  • Benjamin DR, van de Water AT, Peiris CL. Effects of exercise on diastasis of the rectus abdominis muscle in the antenatal and postnatal periods: a systematic review. Physiotherapy. 2014 Mar;100(1):1-8. doi: 10.1016/j.physio.2013.08.005. Epub 2013 Oct 5.

    PMID: 24268942BACKGROUND
  • Mota P, Pascoal AG, Sancho F, Bo K. Test-retest and intrarater reliability of 2-dimensional ultrasound measurements of distance between rectus abdominis in women. J Orthop Sports Phys Ther. 2012 Nov;42(11):940-6. doi: 10.2519/jospt.2012.4115. Epub 2012 Jul 18.

    PMID: 22810966BACKGROUND
  • Mesquita, L. A., Machado, A. V., & Andrade, A. V. (1999). Physiotherapy for reduction of diastasis of the recti adbominis muscles in the postpartum period. Rev Brasil Ginecol Obstet 21, 267-272.

    BACKGROUND
  • Emanuelsson P, Gunnarsson U, Dahlstrand U, Strigard K, Stark B. Operative correction of abdominal rectus diastasis (ARD) reduces pain and improves abdominal wall muscle strength: A randomized, prospective trial comparing retromuscular mesh repair to double-row, self-retaining sutures. Surgery. 2016 Nov;160(5):1367-1375. doi: 10.1016/j.surg.2016.05.035. Epub 2016 Jul 27.

    PMID: 27475817BACKGROUND
  • Gluppe SL, Hilde G, Tennfjord MK, Engh ME, Bo K. Effect of a Postpartum Training Program on the Prevalence of Diastasis Recti Abdominis in Postpartum Primiparous Women: A Randomized Controlled Trial. Phys Ther. 2018 Apr 1;98(4):260-268. doi: 10.1093/ptj/pzy008.

    PMID: 29351646BACKGROUND
  • Kamel DM, Yousif AM. Neuromuscular Electrical Stimulation and Strength Recovery of Postnatal Diastasis Recti Abdominis Muscles. Ann Rehabil Med. 2017 Jun;41(3):465-474. doi: 10.5535/arm.2017.41.3.465. Epub 2017 Jun 29.

    PMID: 28758085BACKGROUND
  • Tuttle, L. J., Fasching, J., Keller, A., Patel, M., Saville, C., Schlaff, R., . . . Gombatto, S. P. (2018). Noninvasive Treatment of Postpartum Diastasis Recti Abdominis: A Pilot Study. Journal of Women's Health Physical Therapy, 42(2), 65-75. doi:10.1097/jwh.0000000000000101

    BACKGROUND
  • Walton, L. M., Costa, A., LaVanture, D., McIlrath, S., & Stebbins, B. (2016). The effects of a 6 week dynamic core stability plank exercise program compared to a traditional supine core stability strengthening program on diastasis recti abdominis closure, pain, oswestry disability index (ODI) and pelvic floor disability index scores (PFDI). Physical Therapy and Rehabilitation, 3(1), 3. doi:10.7243/2055-2386-3-3

    BACKGROUND
  • Thabet AA, Alshehri MA. Efficacy of deep core stability exercise program in postpartum women with diastasis recti abdominis: a randomised controlled trial. J Musculoskelet Neuronal Interact. 2019 Mar 1;19(1):62-68.

    PMID: 30839304BACKGROUND
  • Haskell WL, Lee IM, Pate RR, Powell KE, Blair SN, Franklin BA, Macera CA, Heath GW, Thompson PD, Bauman A; American College of Sports Medicine; American Heart Association. Physical activity and public health: updated recommendation for adults from the American College of Sports Medicine and the American Heart Association. Circulation. 2007 Aug 28;116(9):1081-93. doi: 10.1161/CIRCULATIONAHA.107.185649. Epub 2007 Aug 1.

    PMID: 17671237BACKGROUND
  • Bø, K., et al. (1990). Pelvic floor muscle exercise for the treatment of female stress urinary incontinence: III. Effects of two different degrees of pelvic floor muscle exercises. Neurourol Urodyn 9(5): 489-502.

    BACKGROUND
  • Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017.

    PMID: 11074683BACKGROUND
  • Stuge B, Garratt A, Krogstad Jenssen H, Grotle M. The pelvic girdle questionnaire: a condition-specific instrument for assessing activity limitations and symptoms in people with pelvic girdle pain. Phys Ther. 2011 Jul;91(7):1096-108. doi: 10.2522/ptj.20100357. Epub 2011 May 19.

    PMID: 21596959BACKGROUND
  • Teig CJ, Grotle M, Bond MJ, Prinsen CAC, Engh MAE, Cvancarova MS, Kjollesdal M, Martini A. Norwegian translation, and validation, of the Pelvic Floor Distress Inventory (PFDI-20) and the Pelvic Floor Impact Questionnaire (PFIQ-7). Int Urogynecol J. 2017 Jul;28(7):1005-1017. doi: 10.1007/s00192-016-3209-z. Epub 2017 Jan 6.

    PMID: 28062903BACKGROUND
  • Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther. 2009;17(3):163-70. doi: 10.1179/jmt.2009.17.3.163.

    PMID: 20046623BACKGROUND
  • Gluppe SB, Ellstrom Engh M, Bo K. Curl-up exercises improve abdominal muscle strength without worsening inter-recti distance in women with diastasis recti abdominis postpartum: a randomised controlled trial. J Physiother. 2023 Jul;69(3):160-167. doi: 10.1016/j.jphys.2023.05.017. Epub 2023 Jun 5.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Kari Bø, PhD

    Norwegian School of Sport Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: An assessor blinded parallel group RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof, PhD, PT, Exercise scientist

Study Record Dates

First Submitted

October 4, 2019

First Posted

October 10, 2019

Study Start

January 9, 2020

Primary Completion

December 21, 2022

Study Completion

December 21, 2022

Last Updated

March 2, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations