Extracorporeal Shockwave on Abdominal Adiposity and Lipid Profile

Effect of Extracorporeal Shockwave on Abdominal Adiposity and Lipid Profile in Obese Postmenopausal Women

Almost postmenopausal women store significant extra visceral adipose tissue with unexplained mechanism, yet. Postmenopausal obese women with excess abdominal obesity have raised metabolic risk of numerous cardiovascular diseases, which negatively influence health policy concern. Therefore, actual need to recommend non-invasive approach that cover this lack of quantitative knowledge in clinical management of obese postmenopausal women.

Study Overview

• Status: Completed
• Conditions: Obesity, Abdominal
• Intervention / Treatment: Other: Extracorporeal Shockwave therapy; Other: Balanced low-calorie diet

Detailed Description

Postmenopausal women are usually troubled by increasing weight and waist circumference caused by obesity and androcidal fat redistribution. Abdominal adiposity, defined as a waist circumference ≥88cm in women, measured in the upright position, plus significant elevated lipid profile values. In postmenopausal women, a higher level of physical activity was associated with a more optimal body composition, including lower adiposity and higher lean mass. Management of abdominal obesity involves different techniques i.e., dietary management, exercise therapy, even lifestyle management, and pharmacological management, and surgical interventions. Extracorporeal shockwave provides cavitation phenomena that may facilitate better management of abdominal obesity. Thus, current study will be conducted to investigate effect of extracorporeal shockwave on abdominal adiposity and lipid profile in obese post-menopausal women.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Helwan, Cairo Governate
    • Cairo, Helwan, Cairo Governate, Egypt, 02
      • Helwan General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Their age range 45-60 years old.
• Their body mass index range 30-35 kg/m square.
• Only, obese postmenopausal women with at least one year after stoppage of menses.

Exclusion Criteria:

• Receiving pharmacological treatment.
• Receiving any form of electrotherapy.
• Whom with metabolic, hematological or renal dysfunction.
• Whom have dermatological or cardiovascular or respiratory, digestive or rheumatic disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Study Group (A) (ESWT); 30 participants will receive Extracorporeal Shockwave (one session per week for 6 weeks), in addition to a balanced low-calorie diet (1500 k/cal for 6 weeks).	Other: Extracorporeal Shockwave therapy; 2000 shots, 120mJ pulse energy setting, 3 bar pressure, and 15 Hz for 15 minute per session.; Other: Balanced low-calorie diet; 1500 k/cal for 6 weeks
Placebo Comparator: Control Group (B); 30 participant will receive Balanced low-calorie diet (1500 k/cal for 6 weeks), only.	Other: Balanced low-calorie diet; 1500 k/cal for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist/ hip ratio	anthropometric outcome measure for abdominal adiposity	Pretreatment and Posttreatment of six weeks study protocol.
Skin fold caliper	subcutaneous fat outcome measure	Pretreatment and Posttreatment of six weeks study protocol.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lipid profile	Low-density lipoprotein, High-density lipoprotein, and triglyceride laboratory outcome measures.	Pretreatment and Posttreatment of six weeks study protocol.

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Cairo University
• Investigators: Study Chair: Azza B Nashed, PHD, Professor of Physical Therapy for Women's Health; Study Director: Sherif S El-Shebeni, MSc., Consultant of Obstetrics and Gynecology

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2022
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: February 26, 2024
• First Submitted That Met QC Criteria: March 1, 2024
• First Posted (Actual): March 4, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2024
• Last Update Submitted That Met QC Criteria: July 19, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Abdominal
• Other Study ID Numbers: P.T.REC/012/004043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Will Share whole raw data, therapeutic protocol details for future systematic review and/ or meta-analysis. wish to be valuable

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No