- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06311201
Effect of Pilates Exercises on Diastasis Recti Abdominis in Postpartum Women
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Giza, Egypt
- Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
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 |
---|---|
Active Comparator: Abdominal belt
It consisted of 25 postpartum women who wore abdominal belt for 8 weeks.
|
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.
|
Experimental: Abdominal belt + Pilates exercises
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
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8 weeks
|
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.
|
8 weeks
|
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.
|
8 weeks
|
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.
|
8 weeks
|
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.
|
8 weeks
|
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.
|
8 weeks
|
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.
|
8 weeks
|
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.
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of functional status
Time Frame: 8 weeks
|
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.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Azza BN Kassab, Prof., Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/004256
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Diastasis Recti
-
Foundation University IslamabadActive, not recruitingDiastasis Recti AbdominisPakistan
-
University of Castilla-La ManchaNot yet recruitingDiastasis Recti | Diastasis Recti and Weakness of the Linea Alba | Diastasis Recti Abdominis | Diastasis
-
Bulovka HospitalCompleted
-
Norwegian School of Sport SciencesThe Norwegian Women´s Public Health AssociationCompletedDiastasis Recti | Diastasis Recti AbdominisNorway
-
Karolinska InstitutetHela Kvinnans KlinikRecruiting
-
University of AlcalaCompletedPregnancy Related | Recti DiastasisSpain
-
Marta CavalliRecruitingDiastasis Recti and Weakness of the Linea AlbaItaly
-
University of Missouri-ColumbiaTerminatedDiastasis Recti and Weakness of the Linea AlbaUnited States
-
Queen's UniversityUniversity of TorontoCompletedDiastasis Recti And Weakness Of The Linea AlbaCanada
-
University of ValenciaUniversity Hospital, CaenRecruitingDiastasis Recti | Diastasis Recti and Weakness of the Linea AlbaSpain
Clinical Trials on Abdominal belt
-
Federal University of São PauloFundação de Amparo à Pesquisa do Estado de São PauloCompleted
-
Hvidovre University HospitalWithdrawnIncisional HerniaDenmark
-
The Clatterbridge Cancer Centre NHS Foundation...UnknownCancer of Stomach | Cancer, LungUnited Kingdom
-
Mayo ClinicCompletedDizziness ChronicUnited States
-
Brigham and Women's HospitalEndo Tools Therapeutics S.A.Not yet recruitingObesity | Obesity, Morbid | Weight, Body | Metabolic DiseaseUnited States
-
Sunnybrook Health Sciences CentreCompletedRotator Cuff Impingement SyndromeCanada
-
University of CalgaryCompletedPelvic Girdle Pain
-
Sunnybrook Health Sciences CentreTerminatedObstructive Sleep Apnea | Stroke, IschemicCanada
-
Hospital Central Norte PEMEXRecruitingPerformance of Colonoscopy | Tolerance of ColonoscopyMexico
-
University of PittsburghNational Institute of Neurological Disorders and Stroke (NINDS); National Institute... and other collaboratorsRecruitingCommunity Mobility of Older Adults | Locomotor Adaptability | Gait AutomaticityUnited States