Ultrasound for Healthy Aging

NCT ID: NCT07168525

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-29
• Study Completion Date: 2026-12-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Ultrasound Spa Group

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.

Group Type: EXPERIMENTAL

Ultrasound spa

Intervention Type: 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.

Spa Only Group without ultrasound

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

Group Type: SHAM_COMPARATOR

Sham ultrasound spa

Intervention Type: 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.

Interventions

Ultrasound spa

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

Intervention Type: DEVICE

Sham ultrasound spa

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.

Intervention Type: OTHER

Other Intervention Names

Bathtub with ultrasound; Bathtub with ultrasound deactivated

Eligibility Criteria

Inclusion Criteria

1. Males and females; Age 70 or older

2. BMI <40 kg/m2

3. Ability to walk up a flight of stairs and short ladder

4. Ability to get in and out of a bath

5. Willingness to adhere to the spa treatments regimen

Exclusion Criteria

1. 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.

2. Any medical condition that, in the opinion of the investigator, would place the participant at increased risk for participation.

3. Fecal or urinary incontinence (daily use of depends)

4. Uncontrolled HTN (BP >180) or unstable vital signs that in the opinion of the investigator would place at increased risk for participation

5. 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.

6. History of poor wounds healing lower extremity within the past two years

7. Glycated Hemoglobin (Hgb) A1c level >8.5%

8. Required use of ambulatory assistive devices

9. Laboratory evidence of infection or colonization with multidrug resistant pathogens in the past 90 days

10. History of myocardial infarction (MI), cerebrovascular accident (CVA) within the past year

11. 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

12. Unable to complete procedures in visit 1

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xprize Foundation

UNKNOWN

Sponsor Role: collaborator

The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role: lead

Responsible Party

Blake Rasmussen

Professor and Chairman of Dept. of Cellular & Integrative Physiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Blake Rasmussen, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center at San Antonio

Locations

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Blake Rasmussen, PhD

Role: CONTACT

rasmussenb@uthscsa.edu

210-450-7491

Tiffany Cortes, MD

Role: CONTACT

cortest@uthscsa.edu

210-450-3333

Facility Contacts

Blake Rasmussen, PhD

Role: primary

rasmussenb@uthscsa.edu

(210) 450-7491

Tiffany Cortes, MD

Role: backup

cortest@uthscsa.edu

(210) 450-3333

Other Identifiers

STUDY00001878

Identifier Type: -

Identifier Source: org_study_id