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NCT Number: NCT06317337

Focused Ultrasound Cavitation Augmented With Aerobic Exercise

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.

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Key information

Conditions

Central Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bioflex Aesthetic Clinic

Peshawar, KPK, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

focused ultrasound cavitation augmented with aerobic exercises

Other

Ultrasound cavitation single session per week along with the Aerobic exercises. Aerobic Exercise was Treadmill walk for 30 min with moderate intensity

Primary outcomes

  1. Borg rating of perceived exertion scale

    Time frame: 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.

  2. girth

    Time frame: 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).

  3. 6min walk test

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 19, 2024
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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