Effect of Shock Wave Therapy on Truncal Obesity and Lipid Profile in Obese Post Menopausal Women

NCT ID: NCT05982002

Last Updated: 2023-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-01
• Study Completion Date: 2021-09-01

Brief Summary

This study aimed to evaluate the effect of six weeks extracorporeal shockwave therapy (SWT) on truncal obesity and serum lipids in obese postmenopausal women

Detailed Description

Truncal obesity occurs when the excess abdominal fat around the stomach and abdomen has accumulated to the point where it is likely to have a negative influence on health , increased visceral abdominal fat (VAF) is directly related to abdominal obesity (AO), which is also linked to endothelial dysfunction, inflammation, insulin resistance, diabetes mellitus, hypercholesterolemia, hepatic steatosis metabolic syndrome [MetS] and cancer.

High density lipoprotein (HDL) cholesterol, often known as cardio protective cholesterol, increases in a hypoestrogenic state such postmenopausal status, whereas triglyceride (TG), total cholesterol, and LDL cholesterol levels fall The prevention of CVD and dyslipidemia depends on the management of truncal obesity, and the reduction of serum lipid levels.

Extracorporeal shock wave therapy (ESWT) has lately been popular for treating fat-related disorders by altering the permeability of lipocyte membranes, improving blood flow and hastening macrophages' clearance of debris so cellulite, body contouring and localized fat can all be treated with the safe and non-invasive ESWT technology because to its mode of action in biological tissue In order to identify the best methods for treating abdominal obesity and prevent the risk of developing cardiovascular disease (CVD) in post-menopausal women. The current randomized controlled trial aimed to determine the effect of extracorporeal shockwave therapy (SWT) on truncal obesity and serum lipids in obese postmenopausal women.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control group

Group A: (Control group)20 post menopausal women received moderate intensity aerobic exercise in addition to energy restricted diet 2time/week for 6 -weeks

Group Type: ACTIVE_COMPARATOR

Moderate intensity aerobic exercise

Intervention Type: OTHER

Treadmail training exercise 60%-75% of Maximum heart rate MHR 2 times/ week

Energy-restricted diet

Intervention Type: OTHER

energy intake was 500K calorie below daily requirements on average three meals at the same time of the day

Shock wave group

Group B: (shock wave group)20 post menopausal women received the same intervention as in group A and 12 sessions of shockwave on abdomen twice/week for 6 -weeks

Group Type: EXPERIMENTAL

shock wave

Intervention Type: DEVICE

ESWT (Chattanooga, Intelect RPW, USA) continues mode, hand piece transmitter R SW D20 /20mm, with the following Parameter: Shock pressure of 3-4 bars, wave frequency of 12 Hz.

Moderate intensity aerobic exercise

Intervention Type: OTHER

Treadmail training exercise 60%-75% of Maximum heart rate MHR 2 times/ week

Energy-restricted diet

Intervention Type: OTHER

energy intake was 500K calorie below daily requirements on average three meals at the same time of the day

Interventions

shock wave

ESWT (Chattanooga, Intelect RPW, USA) continues mode, hand piece transmitter R SW D20 /20mm, with the following Parameter: Shock pressure of 3-4 bars, wave frequency of 12 Hz.

Intervention Type: DEVICE

Moderate intensity aerobic exercise

Treadmail training exercise 60%-75% of Maximum heart rate MHR 2 times/ week

Intervention Type: OTHER

Energy-restricted diet

energy intake was 500K calorie below daily requirements on average three meals at the same time of the day

Intervention Type: OTHER

Other Intervention Names

Extracorporeal shock wave therapy

Eligibility Criteria

Inclusion Criteria

• Obese Post menopausal women Body mass index more than or equal 30kg/m2 Waist circumference more than or equal 88 cm Waist hip ratio more than or equal 0.88cm Women not engaged in any procedure to treat obesity or received medication from 6 months

Exclusion Criteria

• women diagnosed with malignancies or received chemical or radiotherapy or hormone replacement therapy or corticosteroids or diagnosed with liver disease or active infection or trauma

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hoda mohammed fathey

Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hala Hanafy

Role: STUDY_DIRECTOR

Professor of physical therapy for women's health

Marwa Hasanin

Role: STUDY_DIRECTOR

Assistant professor of physical therapy for women's health

Hossam Hussien

Role: STUDY_DIRECTOR

Professor of gynaecology and obstetrics

Locations

Faculty of physical therapy

Cairo, , Egypt

Countries

Egypt

References

Troia S, Moreira AM, Pisco D, Noites A, Vale AL, Carvalho P, Vilarinho R. Effect of shock wave therapy associated with aerobic exercise on cellulite: A randomized controlled trial. J Cosmet Dermatol. 2021 Jun;20(6):1732-1742. doi: 10.1111/jocd.13791. Epub 2020 Oct 26.

Reference Type: BACKGROUND

PMID: 33053245 (View on PubMed)

Zhang X, Ma Y. Global trends in research on extracorporeal shock wave therapy (ESWT) from 2000 to 2021. BMC Musculoskelet Disord. 2023 Apr 20;24(1):312. doi: 10.1186/s12891-023-06407-9.

Reference Type: BACKGROUND

PMID: 37081473 (View on PubMed)

Other Identifiers

P.T.REC/012/002823

Identifier Type: -

Identifier Source: org_study_id