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

NCT05982002 | Completed

• 1 other identifier: P.T.REC/012/002823
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity

Keywords

Obesity-menopause-shock wave-lipid profile

Outcome Measures

Primary Outcomes (2)

• Anrhropometric measurement

  involving weight, height, waist circumference and hip circumference measured for each post-menopausal woman . The weight and height were measured using a weight-height scale without shoes and with a thin layer of clothes then calculate the body mass index according to the following equation: BMI=weight/height2 (Kg/m2), for both groups (A\&B), waist circumference were measured pare skin from standing position using tape measure at the narrowest level between the costal margin and the iliac crest at the end of gentle expiration, and the hip circumference was measured at the widest level over the buttocks. Then, waist/hip ratio was calculated by dividing the waist by the hip circumference before and after treatment program for all women in both groups (A and B)

  Before and after 6 weeks of treatment

• Lipid profile measurement

  Fasting sample of venous blood was collected in the morning from each woman in both groups (A\&B) from a vein on the inside of the elbow or the back of the hand after use of local antiseptic for the skin to prevent infection .Serum levels of the total cholesterol (TC), high-density lipoprotein (HDL), low-density lipoprotein (LDL) and triglycerides (TG) was measured by cobas 311 analyzer using a commercially available assay kit according to the manufacturer's instructions (Roche Diagnostics GmbH).

  Before and after 6 weeks of treatment

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Other: Moderate intensity aerobic exercise; Other: Energy-restricted diet

Shock wave group

EXPERIMENTAL

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

Device: shock wave; Other: Moderate intensity aerobic exercise; Other: Energy-restricted diet

Interventions

shock wave 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.

Also known as: Extracorporeal shock wave therapy

Shock wave group

Moderate intensity aerobic exercise OTHER

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

Control group; Shock wave group

Energy-restricted diet OTHER

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

Control group; Shock wave group

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy

Cairo, Egypt

Location

Related Publications (2)

• 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.

  PMID: 33053245 BACKGROUND

• 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.

  PMID: 37081473 BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Hala Hanafy

  Professor of physical therapy for women's health

  STUDY DIRECTOR

• Marwa Hasanin

  Assistant professor of physical therapy for women's health

  STUDY DIRECTOR

• Hossam Hussien

  Professor of gynaecology and obstetrics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 8, 2023
• Study Start: November 1, 2020
• Primary Completion: December 15, 2020
• Study Completion: September 1, 2021
• Last Updated: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)