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NCT Number: NCT07168525

Ultrasound for Healthy Aging

The investigators will study the effects of an ultrasound bath device that uses low-frequency ultrasound on the healthy aging. Participants will have before and after ultrasound assessments of muscle and thinking skills, aging related to the immune system, and body make-up. The group that is assigned to get the ultrasound will have low-frequency ultrasound in a bathtub for 45 minutes, three times weekly for 8 weeks, and the control group will be in the bathtub without the ultrasound turned on.

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Key information

Conditions

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The general approach and study design is that the investigators will recruit 20 healthy older adults (equal numbers of men and women) for the first phase. 10 participants will be randomized to the ultrasound group and 10 will be randomized to the control group. Participants will be stratified by gender and ten randomized to treatment arms. Prior to beginning the intervention, each participant will be tested for muscle function, cognitive function, blood samples will be used to assess immune aging function, and body composition. Each participant will then sit in a bathtub which has been fitted with an ultrasound device which produces low frequency sound waves within the water. The sound waves are undetectable by someone sitting in the tub. The ultrasound intervention group will receive ultrasound for 45 minutes, 3 times per week for 8 weeks. The control group will sit in the same tub for 45 minutes, 3 times per week for 8 weeks but without the ultrasound being turned on. At the end of the 8 weeks, post-testing for muscle, cognitive, immune aging function, and body composition will be performed again.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Males and females; Age 70 or older
  • BMI <40 kg/m2
  • Ability to walk up a flight of stairs and short ladder
  • Ability to get in and out of a bath
  • Willingness to adhere to the spa treatments regimen

Exclusion criteria

  • To accommodate the participants comfortably in our spa, participants with body weight >350 pounds, body girth ≥ 50 inches and height ≥ 6 feet 8 inches will be excluded.
  • Any medical condition that, in the opinion of the investigator, would place the participant at increased risk for participation.
  • Fecal or urinary incontinence (daily use of depends)
  • Uncontrolled HTN (BP >180) or unstable vital signs that in the opinion of the investigator would place at increased risk for participation
  • Any clinically significant rash or formation of rashes or open sores, boils, or infected wounds two weeks prior to screening or any time during the study.
  • History of poor wounds healing lower extremity within the past two years
  • Glycated Hemoglobin (Hgb) A1c level >8.5%
  • Required use of ambulatory assistive devices
  • Laboratory evidence of infection or colonization with multidrug resistant pathogens in the past 90 days
  • History of myocardial infarction (MI), cerebrovascular accident (CVA) within the past year
  • History of prior non-compliance or the presence of history of health condition (drug or alcohol addiction) that would make it difficult for the participant to comply with the study procedures or follow the investor's instructions
  • Unable to complete procedures in visit 1

Treatment and study plan

Ultrasound spa

Device

Each participant will sit in a bathtub which has been fitted with an ultrasound device which produces low frequency sound waves within the water.

Other names: Bathtub with ultrasound

Sham ultrasound spa

Other

The control group will sit in the same tub for 45 minutes, 3 times per week for 8 weeks but without the ultrasound being turned on.

Other names: Bathtub with ultrasound deactivated

Primary outcomes

  1. Knee Extension Strength change

    Time frame: Baseline to 8 weeks

    A sensitive and reliable measure of lower-extremity muscle function andis clinically relevant for predicting mobility limitations and fall risk in older adults measured by Biodex dynamometry.

Secondary outcomes

  1. Change in Short Physical Performance Battery (SBBP)

    Time frame: Baseline to 8 weeks

    A well-established objective measure of lower extremity physical function that includes balance testing, timed 4 meter walk, and timed repeated chair stands.Scores for each test are graded on a 0-4 scale and the total for each test summed to provide a total between 0-12 where 0 is the worst performance and 12 is the best.

  2. Change in Timed Up and Go (TUG)

    Time frame: Baseline to 8 weeks

    The Timed Up and Go (TUG) test is a simple assessment used to evaluate a person's functional mobility and risk of falls, particularly in older adults. The test involves timing how long it takes for an individual to stand up from a chair, walk a short distance, turn around, walk back, and sit down again.

  3. Change in 6 minute walk distance

    Time frame: Baseline to 8 weeks

    Will measure the maximal distance participants can walk during six minutes. Participants will be instructed to "cover as much distance as they can" over a flat surface demarcated by traffic cones while timed by a stopwatch.

  4. Change in Senescence

    Time frame: Baseline to 8 weeks

    Cellular senescence in blood will be measured via immunohistochemistry biochemical analysis and RNA sequencing.

  5. Change in immune aging

    Time frame: Baseline to 8 weeks

    Immune aging in blood will be measured via epigenetic analysis.

  6. Change in cognitive function

    Time frame: Baseline to 8 weeks

    Cognitive function will be measured via the NIH Toolbox Cognition Battery Face Name Associative Memory Exam Test. Participants will be shown 12 pairs of names and faces followed by a 5-25 minute break prior to being shown the pairs again. The possible scores are 0-12. 0 is no names and faces remembered and 12 is all pairs remembered correctly.

  7. Change in lean body mass

    Time frame: Baseline to 8 weeks

    Measured by a DEXA scan

  8. Change in fat mass

    Time frame: Baseline to 8 weeks

    Measured by DEXA scan

Study contacts

Contact information is provided by the study sponsor or research team.

Blake Rasmussen, PhD

CONTACT

[email protected]

210-450-7491

Tiffany Cortes, MD

CONTACT

[email protected]

210-450-3333

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • Xprize Foundation

Registry information

Official study title

Effects of Ultrasound on Healthy Aging

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 11, 2025
Registry last updated
Nov 17, 2025

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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