Aging
Conditions
Keywords
Ultrasound, Muscle function, Cognitive function
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.
Interventions
DEVICEUltrasound 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.
OTHERSham 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.
Sponsors
Xprize Foundation
The University of Texas Health Science Center at San Antonio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
This sham-controlled design improves internal validity by minimizing placebo effects and allows for participant blinding, as the ultrasound is inaudible and imperceptible.
Intervention model description
Randomized controlled 2 arm study
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Extension Strength change | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Timed Up and Go (TUG) | 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. |
| Change in 6 minute walk distance | 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. |
| Change in Senescence | Baseline to 8 weeks | Cellular senescence in blood will be measured via immunohistochemistry biochemical analysis and RNA sequencing. |
| Change in Short Physical Performance Battery (SBBP) | 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. |
| Change in cognitive function | 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. |
| Change in lean body mass | Baseline to 8 weeks | Measured by a DEXA scan |
| Change in fat mass | Baseline to 8 weeks | Measured by DEXA scan |
| Change in immune aging | Baseline to 8 weeks | Immune aging in blood will be measured via epigenetic analysis. |
Countries
United States
Contacts
Primary ContactBlake Rasmussen, PhD
Backup ContactTiffany Cortes, MD
Outcome results
None listed