Focused Ultrasound Cavitation Augmented With Aerobic Exercise

Not Applicable

Completed

• Conditions: Central Obesity
• Interventions: Other: focused ultrasound cavitation augmented with aerobic exercises

• Registration Number: NCT06317337
• Lead Sponsor: Riphah International University

Brief 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.

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 Timeline

• Study Start: 2022-04-15
• Primary Completion: 2023-04-15
• Study Completion: 2023-07-15
• Study First Submitted: 2024-01-18
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-17
• Last Update Submitted: 2024-03-17
• Study First Posted: 2024-03-19
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
focused ultrasound cavitation augmented with aerobic exercise	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
focused ultrasound cavitation	focused ultrasound cavitation augmented with aerobic exercises	Ultrasound cavitation single session per week along with 6min walk test.

Primary Outcome Measures

Name	Time	Method
Borg rating of perceived exertion scale	4 weeks	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.
6min walk test	4weeks	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
girth	4weeks	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).

Trial Locations

Locations (1)

Bioflex Aesthetic Clinic; 🇵🇰 Peshawar, KPK, Pakistan