Focused Ultrasound Cavitation Augmented With Aerobic Exercise

Effect of Focused Ultrasound Cavitation Augmented With Aerobic Exercise in Patients With Central Obesity

This study will determine the combine effects of focused ultrasound cavitation augmented with aerobic exercises. This research could be helpful for the patients who prefer such treatments to make a wise decision that either aerobic exercises in combination with cavitation is the better and much safer treatment option to maintain healthy life.

Study Overview

• Status: Completed
• Conditions: Central Obesity
• Intervention / Treatment: Other: focused ultrasound cavitation augmented with aerobic exercises

Detailed Description

Abdominal obesity can be treated through invasive and non-invasive procedures. The most common invasive protocol is surgical liposuction, this is mostly useful for removing large volume of fat. Nonsurgical approaches included exercises and selective focus energy which target the subcutaneous adipose tissue including focused ultrasound. Focus ultrasound produce cavitation which results in fat cell lysis through mechanical energy without causing any harmful effect on surrounding nerves and connective tissue.

There is an increasing demand for noninvasive fat reduction methods; there is variety of physical treatments in practice for localized fat reduction such as electrical stimulation, mechanical massage, light based therapies and cold low level laser irradiation but clinically most of them failed to meet expectations. Literature reported that clinically High Intensity Focused Ultrasound (HIFU) is most effective for noninvasive fat reduction therapy. Ultrasound causes cavitation phenomena on fat droplet watery cytoplasm interface and eventually rupture of adipocytes and triglycerides release, this whole phenomena is caused through generation of compression and decompression cycle at specific frequency. Ultrasound Fat cavitation is the technique of handling obesity, specially by destroying fat and shaping a body part. There is a limited literature available on effects of aerobic exercises and focused ultrasound cavitation on obesity but there was no literature available on combine effects of both treatments. This study will determine the combine effects of focused ultrasound cavitation augmented with aerobic exercises. This research could be helpful for the patients who prefer such treatments to make a wise decision that either aerobic exercises in combination with cavitation is the better and much safer treatment option to maintain healthy life.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • KPK
    • Peshawar, KPK, Pakistan
      • Bioflex Aesthetic Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Females
• Overweight (Asian BMI scoring)
• 25 to 40 years of age
• Central obesity

Exclusion Criteria:

• Morbidly obesity
• Hypertension
• Arthritis
• Musculoskeletal disorders
• Cardiovascular disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: focused ultrasound cavitation augmented with aerobic exercise; Ultrasound cavitation single session per week along with the Aerobic exercises. Aerobic Exercise was Treadmill walk for 30 min with moderate intensity	Other: focused ultrasound cavitation augmented with aerobic exercises; Ultrasound cavitation single session per week along with the Aerobic exercises. Aerobic Exercise was Treadmill walk for 30 min with moderate intensity
Active Comparator: focused ultrasound cavitation; Ultrasound cavitation single session per week along with 6min walk test.	Other: focused ultrasound cavitation augmented with aerobic exercises; Ultrasound cavitation single session per week along with the Aerobic exercises. Aerobic Exercise was Treadmill walk for 30 min with moderate intensity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Borg rating of perceived exertion scale	The Borg Rating of Perceived Exertion (RPE) scale, developed by Swedish researcher Gunnar Borg, is a tool for measuring an individual's effort and exertion, breathlessness and fatigue during physical work and so is highly relevant for occupational health and safety practice. In its simplest terms, it provides a measure of how hard it feels that the body is working based on the physical sensations that the subject experiences, including increased heart rate, increased respiration or breathing rate, increased sweating and muscle fatigue.	4 weeks
girth	Anthropometry is the measurement of human body dimension such as girths by using surface landmarks for reference. Like other areas of science the procedures and processes depend upon adherence to the particular rules of measurement as determined by national and international standards bodies. The definitions and instructions in this chapter are consistent with the international anthropometric standards body called the International Society for the Advancement of Kinanthropometry (ISAK).	4weeks
6min walk test	The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity	4weeks

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Maria Razzaq, MSCPPT, Riphah International university Gulberg Greens D block Islamabad

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2022
• Primary Completion (Actual): April 15, 2023
• Study Completion (Actual): July 15, 2023

Study Registration Dates

• First Submitted: January 18, 2024
• First Submitted That Met QC Criteria: March 17, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 17, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Abdominal
• Other Study ID Numbers: Sana Bshir

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No