NCT06311201

Brief Summary

The purpose of the study was to investigate the effect of Pilates exercises on diastasis recti abdominis in postpartum women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 8, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 15, 2024

Completed
Last Updated

March 19, 2024

Status Verified

March 1, 2024

Enrollment Period

4 months

First QC Date

March 8, 2024

Last Update Submit

March 17, 2024

Conditions

Keywords

Pilates ExercisesDiastasis Recti AbdominisPostpartum Women

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 COMPARATOR

It consisted of 25 postpartum women who wore abdominal belt for 8 weeks.

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

Other: Abdominal beltOther: Pilates exercises

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.

Abdominal beltAbdominal belt + Pilates exercises

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.

Abdominal belt + Pilates exercises

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Study Sites (1)

Cairo University

Giza, Egypt

Location

MeSH Terms

Interventions

Exercise Movement Techniques

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesTherapeutics

Study Officials

  • Azza BN Kassab, Prof.

    Cairo University

    STUDY CHAIR

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

Locations