Extracorporeal Shockwave on Abdominal Adiposity and Lipid Profile

Not Applicable

Completed

• Conditions: Obesity, Abdominal
• Interventions: Other: Extracorporeal Shockwave therapy; Other: Balanced low-calorie diet

• Registration Number: NCT06290674
• Lead Sponsor: Cairo University

Brief Summary

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.

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 Timeline

• Study Start: 2022-09-11
• Primary Completion: 2024-01-01
• Study Completion: 2024-02-01
• Study First Submitted: 2024-02-26
• Study First Submitted QC: 2024-03-01
• Study First Posted: 2024-03-04
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-19
• Last Update Posted: 2024-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group (A) (ESWT)	Extracorporeal Shockwave therapy	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).
Study Group (A) (ESWT)	Balanced low-calorie diet	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).
Control Group (B)	Balanced low-calorie diet	30 participant will receive Balanced low-calorie diet (1500 k/cal for 6 weeks), only.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Lipid profile	Pretreatment and Posttreatment of six weeks study protocol.	Low-density lipoprotein, High-density lipoprotein, and triglyceride laboratory outcome measures.

Trial Locations

Locations (1)

Helwan General Hospital; 🇪🇬 Cairo, Helwan, Cairo Governate, Egypt