- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05916833
Comparison of Hypopressive Breathing and Noble Technique on DRA in Postpartum Women.
March 12, 2024 updated by: Riphah International University
Comparison of Hypopressive Breathing and Noble Technique on Diastasis Recti Abdominis in Postpartum Women.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
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Islamabad, Punjab, Pakistan, 44000
- Maryam's Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: hypopressive breathing technique
These exercises involved "sucking in the abdomen" and opening the ribs by engaging the accessory inspiratory muscles, such as the serratus anterior, external intercostalis, scalenes, and sternocleidomastoid, while maintaining the glottis closed, a process known as "diaphragmatic suction.
|
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.
|
|
Experimental: noble technique
The Noble technique is (partially sitting up while manually flexing the rectus Abdominis muscles.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified OSWESTRY Low Back pain Index (ODI)
Time Frame: 12 weeks
|
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
|
|
IFSAC (Inventory of Functional Status After Childbirth)
Time Frame: 12 weeks
|
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
|
|
Numeric Pain Rating Scale (NPRS):
Time Frame: 1 day
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: summra andleeb, MS(OMPT), riphah internation university
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 4, 2023
Primary Completion (Actual)
January 1, 2024
Study Completion (Actual)
January 20, 2024
Study Registration Dates
First Submitted
June 14, 2023
First Submitted That Met QC Criteria
June 14, 2023
First Posted (Actual)
June 23, 2023
Study Record Updates
Last Update Posted (Actual)
March 13, 2024
Last Update Submitted That Met QC Criteria
March 12, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/01536 Saima Awan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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