Extracorporeal Shockwave on Abdominal Adiposity and Lipid Profile

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-11

Study Completion Date

2024-02-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obesity, Abdominal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Clinical randomized controlled study

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Double masking (Investigator and Participant)

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Extracorporeal Shockwave therapy

Intervention Type OTHER

2000 shots, 120mJ pulse energy setting, 3 bar pressure, and 15 Hz for 15 minute per session.

Balanced low-calorie diet

Intervention Type OTHER

1500 k/cal for 6 weeks

Control Group (B)

30 participant will receive Balanced low-calorie diet (1500 k/cal for 6 weeks), only.

Group Type PLACEBO_COMPARATOR

Balanced low-calorie diet

Intervention Type OTHER

1500 k/cal for 6 weeks

Interventions

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Extracorporeal Shockwave therapy

2000 shots, 120mJ pulse energy setting, 3 bar pressure, and 15 Hz for 15 minute per session.

Intervention Type OTHER

Balanced low-calorie diet

1500 k/cal for 6 weeks

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No