Post Partum WomenNCT06259240
Prone Plank Exercises for Diastasis Rectus Abdominis in Postpartum Women
A study testing Prone plank exercises and Electrical Stimulation in people with Post Partum Women, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study was to compare between the effects of prone plank exercises versus ES for DRA in postpartum women. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Post Partum Women
- What is being tested?
- Prone plank exercises and Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 30 Apr 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- they had DRA 12 weeks to 36 months postpartum, and were referred to physiotherapy by a gynaecologist, multiparous with the IRD measuring greater than two cm. Age ranged between 20-35 years. Body mass index didn't exceed 30 kg/m2.
Who cannot join
- they were in ongoing pregnancy, twin pregnancy, premature birth before gestation week 37, and exceeded more than thirty-six months postpartum.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of physical therapy labs at kafr El sheikh University
Kafr ash Shaykh, 6850001
Doaa Salah, Senior, 20 101 503 3456, ptdoaasalah@gamil.com
About this study
Official title: Prone Plank Exercises Versus Electrical Stimulation in Treatment of Diastasis Rectus Abdominis in Postpartum Women
The purpose of this study was to compare between the effects of prone plank exercises versus ES for DRA in postpartum women.
Read the detailed description
The study conducted on forty-two woman. They had diastasis rectus abdominis12 weeks to 36 months postpartum. They were randomly divided into two equal groups; group A received prone plank exercises while group B recieved electrical stimulation.All patients recieved three sessions per week foe eight weeks.
- Conditions
- Post Partum Women
- Being tested
- Prone plank exercises, Electrical Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone plank exercisesOther
Patients in this group will recieve prone plank exercises, three times a week, for eight weeks, and with a moderate hard intensity. During the first four weeks, the exercises session began with light walking for five minutes followed by corrected exercises. Firstly, women will perform stable prone plank exercises. Secondly, women will be asked to apply the unilateral position of prone plank. Thirdly, using a 65 cm diameter Swiss ball, women will be asked to assume the prone bridge position. During the last four weeks, women will be asked to repeat the same program noting that the progressive prone plank exercises should be applied in a dosage of 20 repetitions, three sets, holding the contraction for one minute, and taking a break for two minutes.
Electrical StimulationDevice
Electrical Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Prone Plank Exercises | Active comparator | Forty two post partum woman will recieve progressive prone plank exercises, three times a week, for eight weeks, and with a moderate hard intensity. Receives: Other: Prone plank exercises |
| Electrical Stimulation | Sham comparator | Forty two post partum woman will recieve electrical stimulation for the rectus abdominis muscle day after day for 8 weeks. The patient position was relaxed in the crook lying position. The session parameters were 30 minutes/session with a low frequency current (50-100Hz). Receives: Device: Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound Imaging Device
Changes in Interrectus distance above umbilicus at rest from baseline to four weeks after the beginning of intervention
Measured: Eight weeks after the beginning of the intervention
Ultrasound Imaging Device
Changes in Interrectus distance below umblicus at rest from baseline to four weeks after the beginning of intervention
Measured: Eight weeks after the beginning of the intervention
Ultrasound Imaging Device
Changes in Interrectus distance above umbilicus at contraction from baseline to four weeks after the beginning of intervention
Measured: Eight weeks after the beginning of the intervention
Ultrasound Imaging Device
Changes in Interrectus distance below umbilicus at contractionfrom baseline to four weeks after the beginning of intervention
Measured: Eight weeks after the beginning of the intervention
Secondary outcomes (1)
The measuring tape
Changes in waist hip ratio from baseline to four weeks after the beginning of intervention
Measured: Eight weeks after the beginning of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 Mar 2023
- Primary completion20 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Partum WomenStudies of the same condition, open and under way.
- More trials run by Cairo 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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rowida Abd Elgleel Sayed Abd Elgleel, Cairo University
- Investigators
- Fayiz Elshamy, Professor, Study director, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259240
- Sponsor's protocol ID
- Plank Exercises in Diastasis
- Status last verified
- Apr 2024
- First submitted
- 6 Feb 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prone Plank Exercises Versus Electrical Stimulation in Treatment of Diastasis Rectus Abdominis in Postpartum Women
- ClinicalTrials.gov ID
- NCT06259240
- Acronym / sponsor ID
- Plank Exercises in Diastasis
- Conditions
- Post Partum Women
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 20 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 14 Feb 2024 (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 purpose of this study was to compare between the effects of prone plank exercises versus ES for DRA in postpartum women.
Detailed description
The study conducted on forty-two woman. They had diastasis rectus abdominis12 weeks to 36 months postpartum. They were randomly divided into two equal groups; group A received prone plank exercises while group B recieved electrical stimulation.All patients recieved three sessions per week foe eight weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prone Plank Exercises | Active comparator | Other: Prone plank exercisesForty two post partum woman will recieve progressive prone plank exercises, three times a week, for eight weeks, and with a moderate hard intensity. |
| Electrical Stimulation | Sham comparator | Device: Electrical StimulationForty two post partum woman will recieve electrical stimulation for the rectus abdominis muscle day after day for 8 weeks. The patient position was relaxed in the crook lying position. The session parameters were 30 minutes/session with a low frequency current (50-100Hz). |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- they had DRA 12 weeks to 36 months postpartum, and were referred to physiotherapy by a gynaecologist, multiparous with the IRD measuring greater than two cm. Age ranged between 20-35 years. Body mass index didn't exceed 30 kg/m2.
Key exclusion criteria (1 listed)
- they were in ongoing pregnancy, twin pregnancy, premature birth before gestation week 37, and exceeded more than thirty-six months postpartum.
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 |
|---|---|---|
| Prone plank exercisesPatients in this group will recieve prone plank exercises, three times a week, for eight weeks, and with a moderate hard intensity. During the first four weeks, the exercises session began with light walking for five minutes followed by corrected exercises. Firstly, women will perform stable prone plank exercises. Secondly, women will be asked to apply the unilateral position of prone plank. Thirdly, using a 65 cm diameter Swiss ball, women will be asked to assume the prone bridge position. During the last four weeks, women will be asked to repeat the same program noting that the progressive prone plank exercises should be applied in a dosage of 20 repetitions, three sets, holding the contraction for one minute, and taking a break for two minutes. | Other | Prone Plank Exercises |
| Electrical StimulationElectrical Stimulation | Device | Electrical Stimulation |
Primary outcome
Ultrasound Imaging Device
Time frame: Eight weeks after the beginning of the intervention
Changes in Interrectus distance above umbilicus at rest from baseline to four weeks after the beginning of intervention
Ultrasound Imaging Device
Time frame: Eight weeks after the beginning of the intervention
Changes in Interrectus distance below umblicus at rest from baseline to four weeks after the beginning of intervention
Ultrasound Imaging Device
Time frame: Eight weeks after the beginning of the intervention
Changes in Interrectus distance above umbilicus at contraction from baseline to four weeks after the beginning of intervention
Ultrasound Imaging Device
Time frame: Eight weeks after the beginning of the intervention
Changes in Interrectus distance below umbilicus at contractionfrom baseline to four weeks after the beginning of intervention
1 secondary outcome
The measuring tape
Time frame: Eight weeks after the beginning of the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
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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.
Fayiz Elshamy, Professor study director
Kafrelsheikh 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 Prone plank exercises and Electrical Stimulation in people with Post Partum Women, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Apr 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doaa Salah, Senior (20 101 503 3456, ptdoaasalah@gamil.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound Imaging Device (time frame: Eight weeks after the beginning of the intervention). The study lists 4 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 4 Apr 2024.