Diastasis RectiNCT05931159
Effects of AHEs on DrA in Postpartum Women
A study testing Abdominal Hypopressive Training and Conventional Physical therapy for DrA in people with Diastasis Recti, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study is aimed to determine the effects of Abdominal Hypopressive exercises on IRD, Lumbopelvic pain, Body Image and abdominal muscle function in postpartum women. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Diastasis Recti
- What is being tested?
- Abdominal Hypopressive Training and Conventional Physical therapy for DrA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Jun 2023to 22 Dec 2023
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 12 weeks to 36 weeks postpartum
- Both vaginal delivery and C-section
- Lumbopelvic pain (NPRS >4)
- Diagnosis of DrA by calliper: 3 cm below the umbilicus: >22 mm, at the umbilicus: >20 mm, 3 cm above the umbilicus: >14 mm
- Primiparous females
Who cannot join
- Any conditions affecting the ability to perform exercise or activity of daily living.
- Previous spinal or abdominal surgery, and neuromuscular diseases.
- Severe DrA >5cm with the herniation or requiring surgical repair.
- LBP associated with disc herniation, spondylolysis, and degenerative changes of the spine
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Attock Hospital (Private) Limited
Rawalpindi, Punjab Province, 46220
About this study
Official title: Effects of Abdominal Hypopressive Exercises on Diastasis Recti in Postpartum Women
This study is aimed to determine the effects of Abdominal Hypopressive exercises on IRD, Lumbopelvic pain, Body Image and abdominal muscle function in postpartum women.
Read the detailed description
Postnatal women wish to resume abdominal exercises shortly after delivery to improve trunk function and restore the pre-pregnant state of the body. Diastasis recti is a common occurrence in the postpartum period which is associated with both physical impairments and body image concerns. Despite the high prevalence, treatment options are still being explored to identify the best approach to resolve it. Exercise is a conservative method to reduce IRD and improve the associated symptoms and quality of life of postpartum females. Most of the previous studies have used either digital nylon calipers or digital palpation methods for the outcome assessment of DrA which has important implications. Fewer studies have used the gold standard US diagnosis. Despite various studies being conducted on the effect of exercise on DrA, the results are still nonconclusive with a deficiency of a standardized protocol. Multifaceted and clinically meaningful assessments have been proposed to be investigated by the previous literature.
- Conditions
- Diastasis Recti
- Being tested
- Abdominal Hypopressive Training, Conventional Physical therapy for DrA
- Keywords
- Diastasis Recti, Diastasis Recti and weakness of Linea alba, Low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal Hypopressive TrainingOther
Week 1 and 2 - Patient education , Hypopressive Maneuvers in Standing, Sitting and Supine 5-7 repetitions x 5 sets, with a 10-second hold each time, rest for 30 seconds between each set, 2 days/week.
Week 3 and 4, Hypopressive breathing in with varying arm movements along with Week 1 and 2 protocols.
Week 5 to 8 - Hypopressive breathing in kneeling, Four-point kneeling and sitting, and supine positions with varying arm movements 5-7 repetitions x 5 sets, with a 10-second hold each time, rest for 30 seconds between each set, 2 days/week.
Conventional Physical therapy for DrAOther
Week 1 to 4, Draw-in maneuver in supine, Quadruped and Prone lying, Bent knee Fallouts and Curl ups. (8 to 12 repetitions x 3 sets, 2 days/week)
Week 5 to 8, Front and side planks added to week 1 to 4 exercises. (12 to 20 repetitions x e sets, 2 days/week)
| Study group | Role | What they receive |
|---|---|---|
| Abdominal Hypopressive Training | Experimental | The Abdominal hypopressive Exercises along with home plan based on conventional exercises. Receives: Other: Abdominal Hypopressive Training |
| Conventional Physical therapy for DrA | Active comparator | Draw-in maneuver in supine, quarduped, prone lying, bent leg fall outs, curl ups, and front and side planks. Receives: Other: Conventional Physical therapy for DrA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter Recti Distance
Changes from baseline Ultrasound imaging (US) is the gold standard for IRD assessment. USI is an accurate and valid method of measuring IRD size and location. Patient will be graded as having an IRD of > 22 mm, 3 cm below the umbilicus OR > 20 mm at the umbilicus OR >14 mm, 3 cm above the umbilicus.
Measured: 8th Week
Lumbopelvic Pain
Changes from baseline The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. Zero usually represents 'no pain at all' whereas the upper limit of 10 represents 'the worst pain ever possible'.
Measured: 8th Week
The Oswestry Disability Index
Changes from baseline The Oswestry Disability Index (ODI) is a validated, 10-point patient-reported outcome questionnaire. The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.
Measured: 8th Week
Secondary outcomes (2)
Body Shape Questionnaire
Changes from baseline the Body shape questionnaire is a self-reported measurement of body shape concerns designed for women to measure concerns about body image problems. The questionnaire has 34 items scored from 1 to 6 points. The overall total score range is between 34 to 204.
Measured: 8th Week
Double Leg lowering test
Changes from baseline Double leg lowering test is used to assess abdominal muscles and the ability of muscles to maintain the posterior pelvic tilting position against the load. In this test Both legs are raised to a 90-degree angle (vertically) while keeping the upper body flat on the floor. The score is the angle of the legs in degrees from the floor. Total score ranges from 0 to 90 degrees, where 0 degree corresponds to excellent and 90 degrees is for very poor.
Measured: 8th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start13 Jun 2023
- Primary completion1 Dec 2023
- Study completion22 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diastasis RectiStudies 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
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Ehsan, PP-DPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931159
- Sponsor's protocol ID
- REC/01538 Fatima Iftikhar
- Status last verified
- Dec 2023
- First submitted
- 26 Jun 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Abdominal Hypopressive Exercises on Diastasis Recti in Postpartum Women
- ClinicalTrials.gov ID
- NCT05931159
- Acronym / sponsor ID
- REC/01538 Fatima Iftikhar
- Conditions
- Diastasis Recti
- Keywords
- Diastasis Recti, Diastasis Recti and weakness of Linea alba, Low back pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 5 Jul 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.
This study is aimed to determine the effects of Abdominal Hypopressive exercises on IRD, Lumbopelvic pain, Body Image and abdominal muscle function in postpartum women.
Detailed description
Postnatal women wish to resume abdominal exercises shortly after delivery to improve trunk function and restore the pre-pregnant state of the body. Diastasis recti is a common occurrence in the postpartum period which is associated with both physical impairments and body image concerns. Despite the high prevalence, treatment options are still being explored to identify the best approach to resolve it. Exercise is a conservative method to reduce IRD and improve the associated symptoms and quality of life of postpartum females. Most of the previous studies have used either digital nylon calipers or digital palpation methods for the outcome assessment of DrA which has important implications. Fewer studies have used the gold standard US diagnosis. Despite various studies being conducted on the effect of exercise on DrA, the results are still nonconclusive with a deficiency of a standardized protocol. Multifaceted and clinically meaningful assessments have been proposed to be investigated by the previous literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdominal Hypopressive Training | Experimental | Other: Abdominal Hypopressive TrainingThe Abdominal hypopressive Exercises along with home plan based on conventional exercises. |
| Conventional Physical therapy for DrA | Active comparator | Other: Conventional Physical therapy for DrADraw-in maneuver in supine, quarduped, prone lying, bent leg fall outs, curl ups, and front and side planks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 12 weeks to 36 weeks postpartum
- Both vaginal delivery and C-section
- Lumbopelvic pain (NPRS >4)
- Diagnosis of DrA by calliper: 3 cm below the umbilicus: >22 mm, at the umbilicus: >20 mm, 3 cm above the umbilicus: >14 mm
- Primiparous females
Key exclusion criteria (4 listed)
- Any conditions affecting the ability to perform exercise or activity of daily living.
- Previous spinal or abdominal surgery, and neuromuscular diseases.
- Severe DrA >5cm with the herniation or requiring surgical repair.
- LBP associated with disc herniation, spondylolysis, and degenerative changes of the spine
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 |
|---|---|---|
| Abdominal Hypopressive TrainingWeek 1 and 2 - Patient education , Hypopressive Maneuvers in Standing, Sitting and Supine 5-7 repetitions x 5 sets, with a 10-second hold each time, rest for 30 seconds between each set, 2 days/week. Week 3 and 4, Hypopressive breathing in with varying arm movements along with Week 1 and 2 protocols. Week 5 to 8 - Hypopressive breathing in kneeling, Four-point kneeling and sitting, and supine positions with varying arm movements 5-7 repetitions x 5 sets, with a 10-second hold each time, rest for 30 seconds between each set, 2 days/week. | Other | Abdominal Hypopressive Training |
| Conventional Physical therapy for DrAWeek 1 to 4, Draw-in maneuver in supine, Quadruped and Prone lying, Bent knee Fallouts and Curl ups. (8 to 12 repetitions x 3 sets, 2 days/week) Week 5 to 8, Front and side planks added to week 1 to 4 exercises. (12 to 20 repetitions x e sets, 2 days/week) | Other | Conventional Physical therapy for DrA |
Primary outcome
Inter Recti Distance
Time frame: 8th Week
Changes from baseline Ultrasound imaging (US) is the gold standard for IRD assessment. USI is an accurate and valid method of measuring IRD size and location. Patient will be graded as having an IRD of > 22 mm, 3 cm below the umbilicus OR > 20 mm at the umbilicus OR >14 mm, 3 cm above the umbilicus.
Lumbopelvic Pain
Time frame: 8th Week
Changes from baseline The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. Zero usually represents 'no pain at all' whereas the upper limit of 10 represents 'the worst pain ever possible'.
The Oswestry Disability Index
Time frame: 8th Week
Changes from baseline The Oswestry Disability Index (ODI) is a validated, 10-point patient-reported outcome questionnaire. The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.
2 secondary outcomes
Body Shape Questionnaire
Time frame: 8th Week
Double Leg lowering test
Time frame: 8th Week
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 27 Dec 2023.
- Individual participant dataSharing planned: No
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Effects of Corrective Versus Plank Exercises on Diastasis Recti
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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.
Sarah Ehsan, PP-DPT principal investigator
Riphah International 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 Abdominal Hypopressive Training and Conventional Physical therapy for DrA in people with Diastasis Recti, 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 4 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 27 Dec 2023. 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?
Inter Recti Distance (time frame: 8th Week). 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?
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 27 Dec 2023.