Focused Ultrasound Cavitation Augmented With Aerobic Exercise

Central Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06317337
• Other study ID #: Sana Bshir
• Status: Completed
• Phase: N/A
• Start date: April 15, 2022
• Est. completion date: July 15, 2023

Study information

• Verified date: March 2024
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 15, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Obesity
• Obesity
• Obesity, Abdominal

Intervention

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

Locations

Country	Name	City	State
Pakistan	Bioflex Aesthetic Clinic	Peshawar	KPK

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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