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| Name | Class |
|---|---|
| Xprize Foundation | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Blake Rasmussen, PhD | Contact | 210-450-7491 | rasmussenb@uthscsa.edu | |
| Tiffany Cortes, MD | Contact | 210-450-3333 | cortest@uthscsa.edu |
| Name | Affiliation | Role |
|---|---|---|
| Blake Rasmussen, PhD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center at San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
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.
At study completion at the time of publication in a peer review journal
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Randomized controlled 2 arm study
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This sham-controlled design improves internal validity by minimizing placebo effects and allows for participant blinding, as the ultrasound is inaudible and imperceptible.
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| 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. |
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| 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. | 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. | Baseline to 8 weeks |
| Change in Senescence | Cellular senescence in blood will be measured via immunohistochemistry biochemical analysis and RNA sequencing. | Baseline to 8 weeks |
| Change in immune aging | Immune aging in blood will be measured via epigenetic analysis. | 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. | Baseline to 8 weeks |
| Change in lean body mass | Measured by a DEXA scan | Baseline to 8 weeks |
| Change in fat mass | Measured by DEXA scan | Baseline to 8 weeks |