Effect of Pilates Exercises on Diastasis Recti Abdominis in Postpartum Women
1 other identifier
interventional
50
1 country
1
Brief Summary
The purpose of the study was to investigate the effect of Pilates exercises on diastasis recti abdominis in postpartum women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 26, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2024
CompletedFirst Submitted
Initial submission to the registry
March 8, 2024
CompletedFirst Posted
Study publicly available on registry
March 15, 2024
CompletedMarch 19, 2024
March 1, 2024
4 months
March 8, 2024
March 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
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.
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.
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.
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.
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.
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.
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.
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.
8 weeks
Secondary Outcomes (1)
Assessment of functional status
8 weeks
Study Arms (2)
Abdominal belt
ACTIVE COMPARATORIt consisted of 25 postpartum women who wore abdominal belt for 8 weeks.
Abdominal belt + Pilates exercises
EXPERIMENTALIt 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University
Giza, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Azza BN Kassab, Prof.
Cairo University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 8, 2024
First Posted
March 15, 2024
Study Start
September 26, 2023
Primary Completion
January 26, 2024
Study Completion
January 26, 2024
Last Updated
March 19, 2024
Record last verified: 2024-03