Clinical trial NCT06290674: Extracorporeal Shockwave on Abdominal Adiposity and Lipid Profile
Official title: Effect of Extracorporeal Shockwave on Abdominal Adiposity and Lipid Profile in Obese Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Abdominal
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical randomized controlled study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Waist/ hip ratio
timeFrame: Pretreatment and Posttreatment of six weeks study protocol.
measure: Skin fold caliper
timeFrame: Pretreatment and Posttreatment of six weeks study protocol.
Secondary outcomes:
measure: Lipid profile
timeFrame: Pretreatment and Posttreatment of six weeks study protocol.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Helwan General Hospital
state: Helwan, Cairo Governate
Study officials:
affiliation: Professor of Physical Therapy for Women's Health
name: Azza B Nashed, PHD
role: STUDY_CHAIR
affiliation: Consultant of Obstetrics and Gynecology
name: Sherif S El-Shebeni, MSc.
role: STUDY_DIRECTOR
References: