Diastasis Recti AbdominisNCT05916833
Comparison of Hypopressive Breathing and Noble Technique on DRA in Postpartum Women.
A study testing hypopressive breathing and noble technique in people with Diastasis Recti Abdominis, run by Riphah International University at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 24 to 45 years, women only
- Conditions the study is for
- Diastasis Recti Abdominis
- What is being tested?
- hypopressive breathing and noble technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Feb 2023to 20 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- Exclude women who need surgical correction for DRA
- Pelvic organ prolapse
- Para umbilical hernia
- Malignancy
- Bone tuberculosis
- Fibromyalgia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Diastasis Recti Abdominis
- Being tested
- hypopressive breathing, noble technique
- Keywords
- hypopressive, noble technique, DRA, postpartum women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypopressive breathingOther
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 techniqueOther
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.
| Study group | Role | What they receive |
|---|---|---|
| hypopressive breathing technique | Experimental | 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. Receives: Other: hypopressive breathing |
| noble technique | Experimental | The Noble technique is (partially sitting up while manually flexing the rectus Abdominis muscles. Receives: Other: noble technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start4 Feb 2023
- Primary completion1 Jan 2024
- Study completion20 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Diastasis Recti AbdominisStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- summra andleeb, MS(OMPT), Principal investigator, riphah internation university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05916833
- Sponsor's protocol ID
- REC/01536 Saima Awan
- Status last verified
- Mar 2024
- First submitted
- 14 Jun 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11181006Coldron 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.
PubMed 17208034Gilleard 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.
PubMed 86772794. 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.
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.
PubMed 27324871Boissonnault 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.
PubMed 2968609Michalska 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.
PubMed 29512814Logsdon 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.
PubMed 16958723Gjerdingen 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.
PubMed 12949031Eriksson 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.
PubMed 33228602Arranz-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.
PubMed 35908286Radhakrishnan 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.
PubMed 36140446Lee 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.
PubMed 27363572Davenport 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.
PubMed 30337344van 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.
PubMed 26474542
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hypopressive Breathing and Noble Technique on Diastasis Recti Abdominis in Postpartum Women.
- ClinicalTrials.gov ID
- NCT05916833
- Acronym / sponsor ID
- REC/01536 Saima Awan
- Conditions
- Diastasis Recti Abdominis
- Keywords
- hypopressive, noble technique, DRA, postpartum women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 4 Feb 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 20 Jan 2024 (actual)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypopressive breathing technique | Experimental | Other: hypopressive breathingThese 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. |
| noble technique | Experimental | Other: noble techniqueThe Noble technique is (partially sitting up while manually flexing the rectus Abdominis muscles. |
Who may qualify
- Ages
- 24 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- Exclude women who need surgical correction for DRA
- Pelvic organ prolapse
- Para umbilical hernia
- Malignancy
- Bone tuberculosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypopressive breathingHot 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. | Other | hypopressive breathing technique |
| noble techniqueHot 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. | Other | noble technique |
Primary outcome
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Background: PubMed 11181006Axer 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.
- Background: PubMed 17208034Coldron 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.
- Background: PubMed 8677279Gilleard 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.
- Background4. 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.
- Background: PubMed 27324871Sperstad 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.
- Background: PubMed 2968609Boissonnault 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.
- Background: PubMed 29512814Michalska 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.
- Background: PubMed 16958723Logsdon 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.
- Background: PubMed 12949031Gjerdingen 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.
- Background: PubMed 33228602Eriksson 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.
- Background: PubMed 35908286Arranz-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.
- Background: PubMed 36140446Radhakrishnan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
summra andleeb, MS(OMPT) principal investigator
riphah internation university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypopressive breathing and noble technique in people with Diastasis Recti Abdominis, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified OSWESTRY Low Back pain Index (ODI) (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05916833, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.