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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05916833
Other study ID # REC/01536 Saima Awan
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 4, 2023
Est. completion date January 20, 2024

Study information

Verified date March 2024
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of study is to compare the effect of Hypopressive breathing and noble technique on width of Diastasis Recti Abdominis, lumbopelvic pain and maternal functioning in postpartum women.


Description:

Candido shows that Caesarean section increased the likelihood of experiencing an increase in the inter-rectus distance during the postpartum period. Diastasis recti abdominis (DRA) is a common condition in postpartum women that can cause abdominal muscle separation. However, there is a lack of direct comparison between these two techniques. This study aims to compare the effectiveness of the hypopressive breathing and the Noble Technique in improving DRA in postpartum women.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date January 20, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers No
Gender Female
Age group 24 Years to 45 Years
Eligibility Inclusion Criteria: - Multiparous women - History of Cesarean section and vaginal delivery - > 12 weeks postpartum - Measurement is 2cm or more then 2cm of DRA is included by using finger width palpation and Nylon digital caliper - Lumbopelvic pain (NPRS 3 to 8) Exclusion Criteria: - Exclude women who need surgical correction for DRA - Pelvic organ prolapse - Para umbilical hernia - Malignancy - Bone tuberculosis - Fibromyalgia

Study Design


Related Conditions & MeSH terms


Intervention

Other:
hypopressive breathing
Hot pack for 10min.Hypopressive breathing in sitting, lying and standing position. Hypopressive breathing 2 times/weekly, 5sec hold, 2-3reps, 1-2sets for 12 weeks. Session will be weekly progress.
noble technique
Hot pack for 10min. Noble technique in relaxed supine position 2time/weekly, 3-5sec hold, 10-15reps, 2-3sets for 12 weeks. Session will be weekly progress.

Locations

Country Name City State
Pakistan Maryam's Clinic Islamabad Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (19)

4. Gómez FR, Senín-Camargo FJ, Cancela-Cores Á, Patiño-Núñez S, Carballo-Costa L. C0083 Effect of a hipopressive abdominal exercise program on inter-rectus abdominis muscles distance in postpartum.

Arranz-Martin B, Navarro-Brazalez B, Sanchez-Sanchez B, McLean L, Carazo-Diaz C, Torres-Lacomba M. The Impact of Hypopressive Abdominal Exercise on Linea Alba Morphology in Women Who Are Postpartum: A Short-Term Cross-Sectional Study. Phys Ther. 2022 Aug 4;102(8):pzac086. doi: 10.1093/ptj/pzac086. — View Citation

Axer H, Keyserlingk DG, Prescher A. Collagen fibers in linea alba and rectus sheaths. I. General scheme and morphological aspects. J Surg Res. 2001 Mar;96(1):127-34. doi: 10.1006/jsre.2000.6070. — View Citation

Boissonnault JS, Blaschak MJ. Incidence of diastasis recti abdominis during the childbearing year. Phys Ther. 1988 Jul;68(7):1082-6. doi: 10.1093/ptj/68.7.1082. — View Citation

Coldron Y, Stokes MJ, Newham DJ, Cook K. Postpartum characteristics of rectus abdominis on ultrasound imaging. Man Ther. 2008 May;13(2):112-21. doi: 10.1016/j.math.2006.10.001. Epub 2007 Jan 5. — View Citation

Davenport MH, Marchand AA, Mottola MF, Poitras VJ, Gray CE, Jaramillo Garcia A, Barrowman N, Sobierajski F, James M, Meah VL, Skow RJ, Riske L, Nuspl M, Nagpal TS, Courbalay A, Slater LG, Adamo KB, Davies GA, Barakat R, Ruchat SM. Exercise for the prevention and treatment of low back, pelvic girdle and lumbopelvic pain during pregnancy: a systematic review and meta-analysis. Br J Sports Med. 2019 Jan;53(2):90-98. doi: 10.1136/bjsports-2018-099400. Epub 2018 Oct 18. — View Citation

Eriksson Crommert M, Petrov Fieril K, Gustavsson C. Women's experiences of living with increased inter-recti distance after childbirth: an interview study. BMC Womens Health. 2020 Nov 23;20(1):260. doi: 10.1186/s12905-020-01123-1. — View Citation

Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005. — View Citation

Gilleard WL, Brown JM. Structure and function of the abdominal muscles in primigravid subjects during pregnancy and the immediate postbirth period. Phys Ther. 1996 Jul;76(7):750-62. doi: 10.1093/ptj/76.7.750. — View Citation

Gjerdingen DK, Center BA. First-time parents' prenatal to postpartum changes in health, and the relation of postpartum health to work and partner characteristics. J Am Board Fam Pract. 2003 Jul-Aug;16(4):304-11. doi: 10.3122/jabfm.16.4.304. — View Citation

Lee D, Hodges PW. Behavior of the Linea Alba During a Curl-up Task in Diastasis Rectus Abdominis: An Observational Study. J Orthop Sports Phys Ther. 2016 Jul;46(7):580-9. doi: 10.2519/jospt.2016.6536. — View Citation

Logsdon MC, Wisner KL, Pinto-Foltz MD. The impact of postpartum depression on mothering. J Obstet Gynecol Neonatal Nurs. 2006 Sep-Oct;35(5):652-8. doi: 10.1111/j.1552-6909.2006.00087.x. — View Citation

Michalska A, Rokita W, Wolder D, Pogorzelska J, Kaczmarczyk K. Diastasis recti abdominis - a review of treatment methods. Ginekol Pol. 2018;89(2):97-101. doi: 10.5603/GP.a2018.0016. — View Citation

Mousavi SJ, Parnianpour M, Mehdian H, Montazeri A, Mobini B. The Oswestry Disability Index, the Roland-Morris Disability Questionnaire, and the Quebec Back Pain Disability Scale: translation and validation studies of the Iranian versions. Spine (Phila Pa 1976). 2006 Jun 15;31(14):E454-9. doi: 10.1097/01.brs.0000222141.61424.f7. — View Citation

Navarro-Brazalez B, Prieto-Gomez V, Prieto-Merino D, Sanchez-Sanchez B, McLean L, Torres-Lacomba M. Effectiveness of Hypopressive Exercises in Women with Pelvic Floor Dysfunction: A Randomised Controlled Trial. J Clin Med. 2020 Apr 17;9(4):1149. doi: 10.3390/jcm9041149. — View Citation

Noor NM, Aziz AA, Mostapa MR, Awang Z. Validation of the Malay version of the Inventory of Functional Status after Childbirth questionnaire. Biomed Res Int. 2015;2015:972728. doi: 10.1155/2015/972728. Epub 2015 Jan 15. — View Citation

Radhakrishnan M, Ramamurthy K. Efficacy and Challenges in the Treatment of Diastasis Recti Abdominis-A Scoping Review on the Current Trends and Future Perspectives. Diagnostics (Basel). 2022 Aug 24;12(9):2044. doi: 10.3390/diagnostics12092044. — View Citation

Sperstad JB, Tennfjord MK, Hilde G, Ellstrom-Engh M, Bo K. Diastasis recti abdominis during pregnancy and 12 months after childbirth: prevalence, risk factors and report of lumbopelvic pain. Br J Sports Med. 2016 Sep;50(17):1092-6. doi: 10.1136/bjsports-2016-096065. Epub 2016 Jun 20. — View Citation

van de Water AT, Benjamin DR. Measurement methods to assess diastasis of the rectus abdominis muscle (DRAM): A systematic review of their measurement properties and meta-analytic reliability generalisation. Man Ther. 2016 Feb;21:41-53. doi: 10.1016/j.math.2015.09.013. Epub 2015 Oct 3. — View Citation

* Note: There are 19 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Modified OSWESTRY Low Back pain Index (ODI) The Oswestry Low Back Pain Disability Index is a 10-point patient-reported outcome questionnaire that was first published in 1980. It is regarded as the "gold standard" for assessing quality of life (QoL) impairment and disability in persons with low back pain 12 weeks
Primary IFSAC (Inventory of Functional Status After Childbirth) The IFSAC consists of five subscales and 36 items, that is, infant care (6 items), personal care (8items), household activities (12 items), social and community activities (6 items), and occupational activities (4 items). The questionnaires are rated on a 4-point Likert scale and mean scores were calculated with one point being the lowest and four points being the highest scores possible. 12 weeks
Primary Numeric Pain Rating Scale (NPRS): The numeric pain rating scale (NPRS), a scoring system that quantifies pain on a scale from 0 (no pain) to 10 (worst possible agony), was used to determine the pain score. 1 day
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Active, not recruiting NCT05897255 - Effects of SEMG Biofeedback With Core Muscle Strengthening Exercises and Kinesiotaping on Diastasis Recti in Post-partum Women N/A