Accepted for/Published in: JMIR Research Protocols
Date Submitted: Mar 24, 2025
Date Accepted: Jun 5, 2025
Effects of Therapeutic Ultrasound and Aussie current associated with High Intensity Interval Training on abdominal adiposity in overweight and obese young adults: Protocol for a Randomized Control Trial
ABSTRACT
Background:
More than half of the world's population will be overweight or obese by 2035, and it is known that physical exercise, such as high-intensity interval training (HIIT), is a tool for controlling obesity by improving body composition and metabolic profile. Non-invasive techniques, such as therapeutic ultrasound (TUS) and the Aussie current, have shown potential in controlling adipose tissue, but their effects combined with HIIT remain unknown.
Objective:
This study aims to evaluate the effects of TUS+Aussie combined with HIIT on body composition, serum metabolic profile and cardiovascular autonomic modulation (CAM) in obese individuals.
Methods:
This is a randomized, double-blind (researcher and outcomes assessor) clinical study. The study was approved by the Human Research Ethics Committee of the Universidade Federal de São Carlos (number: 7.389.480 and CAAE: 64624522.8.0000.5504). The participants will be randomized into three groups: active TUS+Aussie group associated with HIIT (AG), placebo group for TUS+Aussie associated with HIIT (PG) and TUS+Aussie only group (HG). Primary outcomes include changes in subcutaneous adipose tissue thickness, body composition, and serum metabolic profile. Secondary outcomes assess perceived stress, body image, blood biochemistry, sleep quality, and cardiovascular autonomic modulation (CAM). Data analysis involves linear mixed models estimated using the maximum likelihood method with an appropriate covariance matrix structure.
Results:
A total of 60 participants will be recruited and randomized between February 2024 and June 2025. The baseline assessments and intervention are scheduled to be completed in August 2025, and data collection will be completed by the end of September 2025. Data management is still ongoing, therefore data analysis has not yet been carried out.
Conclusions:
This is the first study to combine TUS+Aussie with HIIT, potentially integrating the effects of lipolysis and fat oxidation and possible changes in the serum metabolic profile and CAM. The results could optimize treatment duration, promote changes in lipid profile and maintain cardiovascular health in people with obesity. Clinical Trial: EnsaiosClinicos.gov.br RBR-4xh6232 (UTN: U1111-1287-2345).
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