AgingNCT07168525
Ultrasound for Healthy Aging
A study testing Ultrasound spa in people with Aging, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Ultrasound spa
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Blake Rasmussen, PhD, (210) 450-7491, rasmussenb@uthscsa.edu
Tiffany Cortes, MD, (210) 450-3333, cortest@uthscsa.edu
About this study
Official title: Effects of Ultrasound on 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.
Read the detailed description
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.
- Conditions
- Aging
- Being tested
- Ultrasound spa, Sham ultrasound spa
- Keywords
- Ultrasound, Muscle function, Cognitive function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound spaDevice
Also called Bathtub with ultrasound
Each participant will sit in a bathtub which has been fitted with an ultrasound device which produces low frequency sound waves within the water.
Sham ultrasound spaOther
Also called Bathtub with ultrasound deactivated
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sham ultrasound spa |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 8 weeks
Secondary outcomes (8)
Change in Short Physical Performance Battery (SBBP)
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.
Measured: Baseline to 8 weeks
Change in Timed Up and Go (TUG)
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.
Measured: Baseline to 8 weeks
Change in 6 minute walk distance
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.
Measured: Baseline to 8 weeks
Change in Senescence
Cellular senescence in blood will be measured via immunohistochemistry biochemical analysis and RNA sequencing.
Measured: Baseline to 8 weeks
Change in immune aging
Immune aging in blood will be measured via epigenetic analysis.
Measured: Baseline to 8 weeks
Change in cognitive function
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.
Measured: Baseline to 8 weeks
Change in lean body mass
Measured by a DEXA scan
Measured: Baseline to 8 weeks
Change in fat mass
Measured by DEXA scan
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start29 Oct 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled 2 arm study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Xprize Foundation
- Responsible party
- Principal investigator, Blake Rasmussen, The University of Texas Health Science Center at San Antonio
- Investigators
- Blake Rasmussen, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168525
- Sponsor's protocol ID
- STUDY00001878
- Status last verified
- Aug 2025
- First submitted
- 26 Aug 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The PI will ensure all mechanisms used to share data will include proper plans and safeguards for the protection of privacy, confidentiality, and security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be traceable to a specific study participant). Plans for archiving and long-term preservation of the data will be implemented, as appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ultrasound on Healthy Aging
- ClinicalTrials.gov ID
- NCT07168525
- Acronym / sponsor ID
- STUDY00001878
- Conditions
- Aging
- Keywords
- Ultrasound, Muscle function, Cognitive function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Xprize Foundation
- Study start
- 29 Oct 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled 2 arm study
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Spa Group | Experimental | Device: Ultrasound spaSessions 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. |
| Spa Only Group without ultrasound | Sham comparator | Other: Sham ultrasound spaSessions will take place three times per week, with spa immersion with no ultrasound lasting 45 minutes each, for a total of eight weeks. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound spaAlso: Bathtub with ultrasoundEach participant will sit in a bathtub which has been fitted with an ultrasound device which produces low frequency sound waves within the water. | Device | Ultrasound Spa Group |
| Sham ultrasound spaAlso: Bathtub with ultrasound deactivatedThe 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 | Spa Only Group without ultrasound |
Primary outcome
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.
8 secondary outcomes
Change in Short Physical Performance Battery (SBBP)
Time frame: Baseline to 8 weeks
Change in Timed Up and Go (TUG)
Time frame: Baseline to 8 weeks
Change in 6 minute walk distance
Time frame: Baseline to 8 weeks
Change in Senescence
Time frame: Baseline to 8 weeks
Change in immune aging
Time frame: Baseline to 8 weeks
Change in cognitive function
Time frame: Baseline to 8 weeks
Change in lean body mass
Time frame: Baseline to 8 weeks
Change in fat mass
Time frame: Baseline to 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: Yes. The PI will ensure all mechanisms used to share data will include proper plans and safeguards for the protection of privacy, confidentiality, and security for data dissemination and reuse (e.g., all data will be thoroughly de-identified and will not be traceable to a specific study participant). Plans for archiving and long-term preservation of the data will be implemented, as appropriate.
Related trials for Aging
RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging
Not yet recruitingObservational study
Clinical Evaluation of Dual-Plane Technique PN-Based Treatment for Horizontal Neck Lines Using DNA Fragment Opmizing Technology Polynucleotide (DOT PN)
Skin Aging, Horizontal Neck Lines
Not yet recruitingObservational study
Clinical Research on Deep-Plane Rejuran S Injection for Improvement in the Apperance of Periorbital Hollowing Using a Cannula Technique
Periorbital Hollowing, Skin Aging
Recruiting
Aquatic Power Training Dosing Strategies and Creatine Supplementation in Older Adults
Aging, Supplementation
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Blake Rasmussen, PhD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound spa in people with Aging, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Blake Rasmussen, PhD (210-450-7491, rasmussenb@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Extension Strength change (time frame: Baseline to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.