Clinical trial NCT06317337: Focused Ultrasound Cavitation Augmented With Aerobic Exercise
Official title: Effect of Focused Ultrasound Cavitation Augmented With Aerobic Exercise in Patients With Central Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Obesity
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 54
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Borg rating of perceived exertion scale
timeFrame: 4 weeks
measure: girth
timeFrame: 4weeks
measure: 6min walk test
timeFrame: 4weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Bioflex Aesthetic Clinic
state: KPK
Study officials:
affiliation: Riphah International university Gulberg Greens D block Islamabad
name: Maria Razzaq, MSCPPT
role: PRINCIPAL_INVESTIGATOR
References: