Ultrasound for Healthy Aging
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ultrasound spa, Sham ultrasound spa.
- Who it may be relevant to
- Registry conditions: Aging. Basic parameters: from 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of Ultrasound on Healthy Aging
Overview
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
- Device 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. - Other 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.
Primary outcome measures
- Knee Extension Strength change [Time frame: Baseline to 8 weeks]
Secondary outcome measures (8)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Texas Health Science Center at San Antonio — San Antonio
Identifiers
NCT: NCT07168525 · STUDY00001878