Ultrasound for Healthy Aging

NCT07168525 | Recruiting DMC FDA Device

• 1 other identifier: STUDY00001878
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aging

Keywords

Ultrasound; Muscle function; Cognitive function

Outcome Measures

Primary Outcomes (1)

• Knee Extension Strength change

  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.

  Baseline to 8 weeks

Secondary Outcomes (8)

• Change in Short Physical Performance Battery (SBBP)

  Baseline to 8 weeks

• Change in Timed Up and Go (TUG)

  Baseline to 8 weeks

• Change in 6 minute walk distance

  Baseline to 8 weeks

• Change in Senescence

  Baseline to 8 weeks

• Change in immune aging

  Baseline to 8 weeks

Study Arms (2)

Ultrasound Spa Group

EXPERIMENTAL

Sessions will take place three times per week, with water-based delivery of low-frequency ultrasound lasting 45 minutes each, for a total of eight weeks.

Device: Ultrasound spa

Spa Only Group without ultrasound

SHAM COMPARATOR

Sessions will take place three times per week, with spa immersion with no ultrasound lasting 45 minutes each, for a total of eight weeks.

Other: Sham ultrasound spa

Interventions

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.

Also known as: Bathtub with ultrasound

Ultrasound Spa Group

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.

Also known as: Bathtub with ultrasound deactivated

Spa Only Group without ultrasound

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Xprize Foundation: collaborator

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Blake Rasmussen, PhD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Blake Rasmussen, PhD

CONTACT

210-450-7491; rasmussenb@uthscsa.edu

Tiffany Cortes, MD

CONTACT

210-450-3333; cortest@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This sham-controlled design improves internal validity by minimizing placebo effects and allows for participant blinding, as the ultrasound is inaudible and imperceptible.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman of Dept. of Cellular & Integrative Physiology

Model Details: Randomized controlled 2 arm study

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 11, 2025
• Study Start: October 29, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: At study completion at the time of publication in a peer review journal

Locations

US (1)