Extracorporeal Shockwave on Abdominal Adiposity and Lipid Profile

NCT06290674 | Completed DMC

• 1 other identifier: P.T.REC/012/004043
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Abdominal

Outcome Measures

Primary Outcomes (2)

• Waist/ hip ratio

  anthropometric outcome measure for abdominal adiposity

  Pretreatment and Posttreatment of six weeks study protocol.

• Skin fold caliper

  subcutaneous fat outcome measure

  Pretreatment and Posttreatment of six weeks study protocol.

Secondary Outcomes (1)

• Lipid profile

  Pretreatment and Posttreatment of six weeks study protocol.

Study Arms (2)

Study Group (A) (ESWT)

ACTIVE COMPARATOR

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).

Other: Extracorporeal Shockwave therapy; Other: Balanced low-calorie diet

Control Group (B)

PLACEBO COMPARATOR

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

Other: Balanced low-calorie diet

Interventions

Extracorporeal Shockwave therapy OTHER

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

Study Group (A) (ESWT)

Balanced low-calorie diet OTHER

1500 k/cal for 6 weeks

Control Group (B); Study Group (A) (ESWT)

Eligibility Criteria

• Age: 45 Years - 60 Years
• Gender Eligibility Details: Current study focuses on Obese Postmenopausal women, based on well-known associated abdominal obesity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Helwan General Hospital

Cairo, Helwan, Cairo Governate, 02, Egypt

Location

MeSH Terms

Conditions

Obesity, Abdominal

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Obesity; 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

• Azza B Nashed, PHD

  Professor of Physical Therapy for Women's Health

  STUDY CHAIR

• Sherif S El-Shebeni, MSc.

  Consultant of Obstetrics and Gynecology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double masking (Investigator and Participant)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapy

Model Details: Clinical randomized controlled study

Study Record Dates

• First Submitted: February 26, 2024
• First Posted: March 4, 2024
• Study Start: September 11, 2022
• Primary Completion: January 1, 2024
• Study Completion: February 1, 2024
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)