[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07168525":3,"trial-entities:NCT07168525":116,"trial-summary:NCT07168525":120},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":47,"secondary_outcomes":52,"sex":77,"minimum_age":78,"maximum_age":79,"healthy_volunteers":15,"eligibility_criteria":80,"std_ages":84,"locations":86,"central_contacts":106,"overall_officials":111,"references":114,"see_also_links":115},"NCT07168525","STUDY00001878","Ultrasound for Healthy Aging","Effects of Ultrasound on Healthy Aging","RECRUITING","2026-12-31","2025-08","2025-11-17","2025-10-29","The University of Texas Health Science Center at San Antonio","OTHER",true,"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.",[19],"Aging",[21,22,23],"Ultrasound","Muscle function","Cognitive function","INTERVENTIONAL","SUPPORTIVE_CARE",[27],"NA",{"count":29,"type":30},20,"ESTIMATED",[32,40],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":38},"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.",[37],"Ultrasound Spa Group",[39],"Bathtub with ultrasound",{"type":14,"name":41,"description":42,"armGroupLabels":43,"otherNames":45},"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.",[44],"Spa Only Group without ultrasound",[46],"Bathtub with ultrasound deactivated",[48],{"measure":49,"description":50,"timeFrame":51},"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",[53,56,59,62,65,68,71,74],{"measure":54,"description":55,"timeFrame":51},"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.",{"measure":57,"description":58,"timeFrame":51},"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.",{"measure":60,"description":61,"timeFrame":51},"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.",{"measure":63,"description":64,"timeFrame":51},"Change in Senescence","Cellular senescence in blood will be measured via immunohistochemistry biochemical analysis and RNA sequencing.",{"measure":66,"description":67,"timeFrame":51},"Change in immune aging","Immune aging in blood will be measured via epigenetic analysis.",{"measure":69,"description":70,"timeFrame":51},"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.",{"measure":72,"description":73,"timeFrame":51},"Change in lean body mass","Measured by a DEXA scan",{"measure":75,"description":76,"timeFrame":51},"Change in fat mass","Measured by DEXA scan","ALL","70 Years",null,{"inclusion":81,"exclusion":82,"raw_text":83},[],[],"Inclusion Criteria:\n\n1. Males and females; Age 70 or older\n2. BMI \\\u003C40 kg\u002Fm2\n3. Ability to walk up a flight of stairs and short ladder\n4. Ability to get in and out of a bath\n5. Willingness to adhere to the spa treatments regimen\n\nExclusion Criteria:\n\n1. 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.\n2. Any medical condition that, in the opinion of the investigator, would place the participant at increased risk for participation.\n3. Fecal or urinary incontinence (daily use of depends)\n4. Uncontrolled HTN (BP \\>180) or unstable vital signs that in the opinion of the investigator would place at increased risk for participation\n5. 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.\n6. History of poor wounds healing lower extremity within the past two years\n7. Glycated Hemoglobin (Hgb) A1c level \\>8.5%\n8. Required use of ambulatory assistive devices\n9. Laboratory evidence of infection or colonization with multidrug resistant pathogens in the past 90 days\n10. History of myocardial infarction (MI), cerebrovascular accident (CVA) within the past year\n11. 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\n12. Unable to complete procedures in visit 1",[85],"OLDER_ADULT",[87],{"facility":88,"status":8,"city":89,"state":90,"zip":91,"country":92,"contacts":93,"geoPoint":103},"University of Texas Health Science Center at San Antonio","San Antonio","Texas","78229","United States",[94,99],{"name":95,"role":96,"phone":97,"email":98},"Blake Rasmussen, PhD","CONTACT","(210) 450-7491","rasmussenb@uthscsa.edu",{"name":100,"role":96,"phone":101,"email":102},"Tiffany Cortes, MD","(210) 450-3333","cortest@uthscsa.edu",{"lat":104,"lon":105},29.42412,-98.49363,[107,109],{"name":95,"role":96,"phone":108,"email":98},"210-450-7491",{"name":100,"role":96,"phone":110,"email":102},"210-450-3333",[112],{"name":95,"affiliation":13,"role":113},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":117,"biomarkers":119},[118],"Healthy Aging",[],{"nct_id":4,"found":15,"summary":121,"prompt_version":131},{"design":122,"status":123,"heading":124,"summary":125,"follow_up":126,"word_count":127,"commitments":128,"compensation":129,"drugs_mentioned":130},"This study will involve 20 healthy older adults, split into two groups. One group will receive the ultrasound treatment, and the other will sit in the tub without the ultrasound turned on.","completed","Ultrasound for Healthy Aging Study","This study is looking at how an \"Ultrasound spa\" might affect healthy aging. You would sit in a special bathtub that uses low-frequency sound waves in the water. Researchers want to see if this helps with muscle strength, thinking skills, immune system aging, and body make-up. To join, you need to be 70 or older, able to walk stairs and get in and out of a bath, and willing to do the spa treatments. The main goal is to see if there's a change in knee extension strength after 8 weeks. This study is currently unclear about its recruitment status.","Your knee extension strength will be measured at the beginning and again after 8 weeks.",100,"You would sit in a special bathtub for 45 minutes, 3 times a week for 8 weeks. Before and after this period, you will have tests for muscle function, thinking skills, blood samples, and body composition.","Not stated in the trial record.",[34],"v2"]