Effect of Ultrasound Cavitation on Static and Dynamic Balance in Obese Postnatal Women With Diastasis Recti

NCT ID: NCT05900856

Last Updated: 2024-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-09
• Study Completion Date: 2023-12-09

Brief Summary

the aim of this study is to investigate the efficacy of ultrasound cavitation on static and dynamic balance in obese postnatal women with diastasis recti

Detailed Description

Rectus diastasis defined as the widening of the linea alba by more than 2 cm at the midline. A great proportion of pregnant women are complaining from rectus diastasis during pregnancy reaching 100% of all women that may continue for years after delivery in 66% of women, and do not return to the first state automatically. This occurs due to a combination of physiologic, hormonal and mechanical factors, leading to reduction of abdominal muscle functional strength, increased low back pain out of increased lumbar hyperlordosis and postural instability, which may seriously disable woman from taking care of her baby, perform her daily activities. Weight gain is one of the predisposing factors that increases the possibility of developing rectus diastasis postpartum. Being obese increases liability to have rectus diastasis as carrying excess abdominal fats puts greater pressure against linea alba and can develop or aggravate symptoms for both men and women. This massively displaces the center of gravity anteriorly, disturbs body balance, increases joint loads and influences negatively pelvis posture leading to increased anterior pelvic tilt with subsequent exaggerated lumbar hyperlordosis. Ultrasound cavitation is the most revolutionary method that destroys excess body fat through creating microbubbles and releasing energy that breaks down fat cells. This trial has two groups: one will be treated by low caloric diet regimen only and the second one will be treated by ultrasound cavitation in addition to low caloric diet regimen for eight weeks

Conditions

Rectus Diastasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

low caloric diet regimn

patients will follow low caloric diet regimn (1600: 2000 Kcal/ day), lipids approximately (20: 35%) of total caloric intake, protein approximately (10: 35%) of total caloric intake and high complexed carbohydrate intake approximately (45: 65%) of total caloric intake (with increased fiber-rich whole grain breads, cereals, fruits and vegetables), for eight weeks.

Group Type: EXPERIMENTAL

low caloric diet regimen

Intervention Type: OTHER

lipids approximately (20: 35%) of total caloric intake, protein approximately (10: 35%) of total caloric intake and high complexed carbohydrate intake approximately (45: 65%) of total caloric intake (with increased fiber-rich whole grain breads, cereals, fruits and vegetables), for eight weeks.

ultrasound cavitation for 30 minutes, twice per week for eight weeks and low caloric diet regimn

ultrasound cavitation, Dae Yang, Mabel 6, frequency (50: 60) Hz, power consumption 150 W, power input AC (100: 230) V, hand probe diameter 8.0 cm, serial number DY73-15037, produced by DAEYANG MEDICAL company, made in Korea. the device will be applied for 30 minutes on the abdominal area, twice per week for eight weeks.

low caloric diet regimn patients will follow low caloric diet regimn (1600: 2000 Kcal/ day), lipids approximately (20: 35%) of total caloric intake, protein approximately (10: 35%) of total caloric intake and high complexed carbohydrate intake approximately (45: 65%) of total caloric intake (with increased fiber-rich whole grain breads, cereals, fruits and vegetables), for eight weeks.

Group Type: EXPERIMENTAL

low caloric diet regimen

Intervention Type: OTHER

lipids approximately (20: 35%) of total caloric intake, protein approximately (10: 35%) of total caloric intake and high complexed carbohydrate intake approximately (45: 65%) of total caloric intake (with increased fiber-rich whole grain breads, cereals, fruits and vegetables), for eight weeks.

ultrasound cavitation

Intervention Type: DEVICE

patients will assume standing position, the abdominal area will be divided vertically into 2 equal sections, right and left segment, extending bilaterally from the line stretching between the mid axilla above and the iliac crest below, and upward from center of diaphragm to the midpoint extending between two iliac crest below, then from supine lying position the cavitation head will be applied on each abdominal segment for 15 minutes with total treatment time 30 minutes twice per week for eight weeks

Interventions

low caloric diet regimen

lipids approximately (20: 35%) of total caloric intake, protein approximately (10: 35%) of total caloric intake and high complexed carbohydrate intake approximately (45: 65%) of total caloric intake (with increased fiber-rich whole grain breads, cereals, fruits and vegetables), for eight weeks.

Intervention Type: OTHER

ultrasound cavitation

patients will assume standing position, the abdominal area will be divided vertically into 2 equal sections, right and left segment, extending bilaterally from the line stretching between the mid axilla above and the iliac crest below, and upward from center of diaphragm to the midpoint extending between two iliac crest below, then from supine lying position the cavitation head will be applied on each abdominal segment for 15 minutes with total treatment time 30 minutes twice per week for eight weeks

Intervention Type: DEVICE

Other Intervention Names

hypocaloric diet (1600: 2000 Kcal/ day); Dae Yang, Mabel 6, serial number DY73-15037, produced by DAEYANG MEDICAL company

Eligibility Criteria

Inclusion Criteria

1. All women had a diastasis recti more than 2.5 cm and less than 4 cm in supra umbilical region.

2. Their ages were ranged from 25: 35 years.

3. Their BMI was more than 30 Kg/ m2.

4. All women were with lumbar hyperlordosis.

5. All women were multipara.

6. Their mode of delivery was normal vaginal delivery.

7. They were selected from 2: 5 months postnatal.

Exclusion Criteria

1. Previous cesarean section.

2. Previous abdominal and/ or back operation.

3. Spinal disorders.

4. Abdominal skin diseases.

5. Serious diseases such as heart disease, pace maker, uncontrolled diabetes or hypertension, autoimmune disease, malignancy, gastric ulcer, liver or renal failure and any other contraindication for body sculpting-weight loss.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Asmaa Maher Ahmed Zahran

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Asmaa Maher Ahmed Zahran

Giza, , Egypt

Countries

Egypt

Other Identifiers

p. t.REC/012/003570

Identifier Type: -

Identifier Source: org_study_id