Diastasis RectiNCT06311201
Effect of Pilates Exercises on Diastasis Recti Abdominis in Postpartum Women
A study testing Abdominal belt and Pilates exercises in people with Diastasis Recti, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the study was to investigate the effect of Pilates exercises on diastasis recti abdominis in postpartum women. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Diastasis Recti
- What is being tested?
- Abdominal belt and Pilates exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Sep 2023to 26 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Postpartum women (7 days after delivery) having diastasis recti (separation between the two recti more than 2.5cm at the level of umbilicus).
- Multiparous women (2-3) times delivered vaginally with or without episiotomy.
- Their age ranged from 20 -35 years old.
- Their BMI was less than 30 kg/cm2.
Who cannot join
- Abdominal or back surgery.
- Abdominal hernia.
- History of abnormal pregnancy, uterine fibroid or polyhydraminos during pregnancy.
- Neurological disorders as multiple sclerosis, stroke and spinal lesion.
- Musculoskeletal diseases such as fractures muscle strains, severe knee osteoarthritis which may affect their physical activity.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study was to investigate the effect of Pilates exercises on diastasis recti abdominis in postpartum women.
Read the detailed description
Rectus diastasis is relatively common having negative health consequences for women during and after pregnancy (ante-and postnatal periods). Varying estimates of incidence of rectus diastasis have been reported ranging from 66% to 100% during the third trimester of pregnancy, and up to 53% immediately after delivery. Among patients with urogynecological disorders, 52% were found to have a rectus diastasis and 66% had at least one type of pelvic floor dysfunction.
A diastasis can contribute to lower back pain and strain due to other muscles being overworked or compensating for the lack of integrity of abdominals, unstable core, pelvic and back muscles, poor posture, shallow breathing and uterine prolapse. This may result in altered trunk mechanics, impaired pelvic stability and changed posture, which leave the lumbar spine and pelvis more vulnerable to injury.
Facilitation, concentric activation, and stabilization of the abdominal muscles occurred during core stability exercise are used to correct diastasis recti. Pilates has been known to improve the strength and flexibility of muscles, particularly the abdominal muscles, lower back, hip and buttocks i.e. the core musculature thus helping in improving core stability.
Uptill now, there was no previous studies have examined the impact of Pilates training on rectus abdominis diastasis in postpartum women. So, this study will be valuable benefits for medical services organizations and will increase body of knowledge of physical therapists in scientific field.
- Conditions
- Diastasis Recti
- Being tested
- Abdominal belt, Pilates exercises
- Keywords
- Pilates Exercises, Diastasis Recti Abdominis, Postpartum Women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal beltOther
This was used for all women in both groups (A and B) for 8 weeks starting from the 7th days after delivery. The women was asked to wear the abdominal belt throughout the day except when bathing, eating and sleeping. The binder was worn over the skin directly or on a thin layer of clothing. The side of the abdominal binder without the straps was pulled over by the woman's stomach with one hand. The side of the binder with straps was stretched across the stomach and pulled to the center of the abdomen. The straps then was fitted into the buckles. Women were instructed not to wear the binder too tight or too loose as it might irritate the skin and produce difficulty in breathing creating discomfort. They were asked to inspect their skin regularly for any signs of sensitivity.
Pilates exercisesOther
The Pilates exercise program for the study group (B) consisted of a 10-minute warm-up with low-intensity exercises, followed by a 40-minute central part with floor exercises like leg circles, kicks, and stretches. It included the classic "hundred" exercise, performed with proper form. Each exercise had two sets of 10 repetitions. The session ended with a 10-minute cool-down of stretching exercises, supervised by a physical therapist. The program was conducted three times per week, one hour per session, for eight weeks, starting from the 7th day after delivery.
| Study group | Role | What they receive |
|---|---|---|
| Abdominal belt | Active comparator | It consisted of 25 postpartum women who wore abdominal belt for 8 weeks. Receives: Other: Abdominal belt |
| Abdominal belt + Pilates exercises | Experimental | It consisted of 25 postpartum women who followed Pilates training program, 3 times/week for 1 hour the session in addition to wearing abdominal belt, for 8 weeks Receives: Other: Abdominal belt; Other: Pilates exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of separation between the two-rectus abdominis muscles above the umbilicus at rest
The distance between the recti muscles was measured 4.5 cm above the umbilicus at rest at the beginning and again at the end of the study duration.
Measured: 8 weeks
Measurement of separation between the two-rectus abdominis muscles above the umbilicus during contraction
The distance between the recti muscles was measured 4.5 cm above the umbilicus during contraction at the beginning and again at the end of the study duration.
Measured: 8 weeks
Measurement of separation between the two-rectus abdominis muscles at level of the umbilicus at rest
The distance between the recti muscles was measured at level of the umbilicus at rest at the beginning and again at the end of the study duration.
Measured: 8 weeks
Measurement of separation between the two-rectus abdominis muscles at level of the umbilicus during contraction
The distance between the recti muscles was measured at level of the umbilicus during contraction at the beginning and again at the end of the study duration.
Measured: 8 weeks
Measurement of separation between the two-rectus abdominis muscles below the umbilicus at rest
The distance between the recti muscles was measured 4.5 cm below the umbilicus at rest at the beginning and again at the end of the study duration.
Measured: 8 weeks
Measurement of separation between the two-rectus abdominis muscles below the umbilicus during contraction
The distance between the recti muscles was measured 4.5 cm below the umbilicus during contraction at the beginning and again at the end of the study duration.
Measured: 8 weeks
Assessment of trunk flexion strength
Trunk flexion strength was graded from 0 to 5 using Daniels and Worthingham's procedure before and after the end of the study program. For grades 3-5, the patient curled up through the full range of motion until the scapulae cleared the table. For grade 2, the patient just lifted their head off the table. For grades 0 and 1, the therapist used assisted forward lean or coughing techniques while palpating the rectus abdominis.
Measured: 8 weeks
Assessment of static trunk flexion endurance
It was tested before and after the end of the study program by adopting the most challenging position that was achieved in the strength test, and instructing the participating women to hold that position as long as possible. Standardized verbal encouragement was provided by the assessor, and the holding time was determined using a stopwatch. Three repetitions of the static endurance test were performed with at least 3 minutes of rest between trials; the best (longest holding time) of the three trials was used to represent the participant's endurance. The same position used to evaluate trunk flexion endurance at the initial evaluation was used in subsequent evaluations, even if the woman's strength grade improved between evaluations.
Measured: 8 weeks
Secondary outcomes (1)
Assessment of functional status
All participating women with diastasis recti in both groups (A \& B) were asked to fill the Inventory of functional status after childbirth questionnaire before and after the end of the study program. This questionnaire includes five domains and 36 items, that is, infant care (6 items), personal care (8 items), household activities (12 items), social and community activities (6 items), and occupational activities (4 items). The questionnaire was rated on a 4-point Likert scale and the mean score was calculated with one point being the lowest and four points being the highest scores possible. Higher scores indicated better functional status.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start26 Sep 2023
- Primary completion26 Jan 2024
- Study completion26 Jan 2024
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 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
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Esam Ghareeb Hasan, Cairo University
- Investigators
- Azza BN Kassab, Prof., Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311201
- Sponsor's protocol ID
- P.T.REC/012/004256
- Status last verified
- Mar 2024
- First submitted
- 8 Mar 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pilates Exercises on Diastasis Recti Abdominis in Postpartum Women
- ClinicalTrials.gov ID
- NCT06311201
- Acronym / sponsor ID
- P.T.REC/012/004256
- Conditions
- Diastasis Recti
- Keywords
- Pilates Exercises, Diastasis Recti Abdominis, Postpartum Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 26 Jan 2024 (actual)
- Study completion
- 26 Jan 2024 (actual)
- First posted
- 15 Mar 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 the study was to investigate the effect of Pilates exercises on diastasis recti abdominis in postpartum women.
Detailed description
Rectus diastasis is relatively common having negative health consequences for women during and after pregnancy (ante-and postnatal periods). Varying estimates of incidence of rectus diastasis have been reported ranging from 66% to 100% during the third trimester of pregnancy, and up to 53% immediately after delivery. Among patients with urogynecological disorders, 52% were found to have a rectus diastasis and 66% had at least one type of pelvic floor dysfunction.
A diastasis can contribute to lower back pain and strain due to other muscles being overworked or compensating for the lack of integrity of abdominals, unstable core, pelvic and back muscles, poor posture, shallow breathing and uterine prolapse. This may result in altered trunk mechanics, impaired pelvic stability and changed posture, which leave the lumbar spine and pelvis more vulnerable to injury.
Facilitation, concentric activation, and stabilization of the abdominal muscles occurred during core stability exercise are used to correct diastasis recti. Pilates has been known to improve the strength and flexibility of muscles, particularly the abdominal muscles, lower back, hip and buttocks i.e. the core musculature thus helping in improving core stability.
Uptill now, there was no previous studies have examined the impact of Pilates training on rectus abdominis diastasis in postpartum women. So, this study will be valuable benefits for medical services organizations and will increase body of knowledge of physical therapists in scientific field.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdominal belt | Active comparator | Other: Abdominal beltIt consisted of 25 postpartum women who wore abdominal belt for 8 weeks. |
| Abdominal belt + Pilates exercises | Experimental | Other: Abdominal belt, Other: Pilates exercisesIt consisted of 25 postpartum women who followed Pilates training program, 3 times/week for 1 hour the session in addition to wearing abdominal belt, for 8 weeks |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Postpartum women (7 days after delivery) having diastasis recti (separation between the two recti more than 2.5cm at the level of umbilicus).
- Multiparous women (2-3) times delivered vaginally with or without episiotomy.
- Their age ranged from 20 -35 years old.
- Their BMI was less than 30 kg/cm2.
Key exclusion criteria (5 listed)
- Abdominal or back surgery.
- Abdominal hernia.
- History of abnormal pregnancy, uterine fibroid or polyhydraminos during pregnancy.
- Neurological disorders as multiple sclerosis, stroke and spinal lesion.
- Musculoskeletal diseases such as fractures muscle strains, severe knee osteoarthritis which may affect their physical activity.
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 beltThis was used for all women in both groups (A and B) for 8 weeks starting from the 7th days after delivery. The women was asked to wear the abdominal belt throughout the day except when bathing, eating and sleeping. The binder was worn over the skin directly or on a thin layer of clothing. The side of the abdominal binder without the straps was pulled over by the woman's stomach with one hand. The side of the binder with straps was stretched across the stomach and pulled to the center of the abdomen. The straps then was fitted into the buckles. Women were instructed not to wear the binder too tight or too loose as it might irritate the skin and produce difficulty in breathing creating discomfort. They were asked to inspect their skin regularly for any signs of sensitivity. | Other | Abdominal belt, Abdominal belt + Pilates exercises |
| Pilates exercisesThe Pilates exercise program for the study group (B) consisted of a 10-minute warm-up with low-intensity exercises, followed by a 40-minute central part with floor exercises like leg circles, kicks, and stretches. It included the classic "hundred" exercise, performed with proper form. Each exercise had two sets of 10 repetitions. The session ended with a 10-minute cool-down of stretching exercises, supervised by a physical therapist. The program was conducted three times per week, one hour per session, for eight weeks, starting from the 7th day after delivery. | Other | Abdominal belt + Pilates exercises |
Primary outcome
Measurement of separation between the two-rectus abdominis muscles above the umbilicus at rest
Time frame: 8 weeks
The distance between the recti muscles was measured 4.5 cm above the umbilicus at rest at the beginning and again at the end of the study duration.
Measurement of separation between the two-rectus abdominis muscles above the umbilicus during contraction
Time frame: 8 weeks
The distance between the recti muscles was measured 4.5 cm above the umbilicus during contraction at the beginning and again at the end of the study duration.
Measurement of separation between the two-rectus abdominis muscles at level of the umbilicus at rest
Time frame: 8 weeks
The distance between the recti muscles was measured at level of the umbilicus at rest at the beginning and again at the end of the study duration.
Measurement of separation between the two-rectus abdominis muscles at level of the umbilicus during contraction
Time frame: 8 weeks
The distance between the recti muscles was measured at level of the umbilicus during contraction at the beginning and again at the end of the study duration.
Measurement of separation between the two-rectus abdominis muscles below the umbilicus at rest
Time frame: 8 weeks
The distance between the recti muscles was measured 4.5 cm below the umbilicus at rest at the beginning and again at the end of the study duration.
Measurement of separation between the two-rectus abdominis muscles below the umbilicus during contraction
Time frame: 8 weeks
The distance between the recti muscles was measured 4.5 cm below the umbilicus during contraction at the beginning and again at the end of the study duration.
Assessment of trunk flexion strength
Time frame: 8 weeks
Trunk flexion strength was graded from 0 to 5 using Daniels and Worthingham's procedure before and after the end of the study program. For grades 3-5, the patient curled up through the full range of motion until the scapulae cleared the table. For grade 2, the patient just lifted their head off the table. For grades 0 and 1, the therapist used assisted forward lean or coughing techniques while palpating the rectus abdominis.
Assessment of static trunk flexion endurance
Time frame: 8 weeks
It was tested before and after the end of the study program by adopting the most challenging position that was achieved in the strength test, and instructing the participating women to hold that position as long as possible. Standardized verbal encouragement was provided by the assessor, and the holding time was determined using a stopwatch. Three repetitions of the static endurance test were performed with at least 3 minutes of rest between trials; the best (longest holding time) of the three trials was used to represent the participant's endurance. The same position used to evaluate trunk flexion endurance at the initial evaluation was used in subsequent evaluations, even if the woman's strength grade improved between evaluations.
1 secondary outcome
Assessment of functional status
Time frame: 8 weeks
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 19 Mar 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.
Azza BN Kassab, Prof. study chair
Cairo 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 belt and Pilates exercises in people with Diastasis Recti, 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 4 inclusion and 5 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 19 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 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. 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?
Measurement of separation between the two-rectus abdominis muscles above the umbilicus at rest (time frame: 8 weeks). The study lists 8 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 19 Mar 2024.