Ultrasound for Healthy Aging

Официальное название

Effects of Ultrasound on Healthy Aging

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Другое 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.

Первичные конечные точки

• Knee Extension Strength change [Срок оценки: Baseline to 8 weeks]

Вторичные конечные точки (8)

• Change in Short Physical Performance Battery (SBBP) [Срок оценки: Baseline to 8 weeks]
• Change in Timed Up and Go (TUG) [Срок оценки: Baseline to 8 weeks]
• Change in 6 minute walk distance [Срок оценки: Baseline to 8 weeks]
• Change in Senescence [Срок оценки: Baseline to 8 weeks]
• Change in immune aging [Срок оценки: Baseline to 8 weeks]
• Change in cognitive function [Срок оценки: Baseline to 8 weeks]
• Change in lean body mass [Срок оценки: Baseline to 8 weeks]
• Change in fat mass [Срок оценки: Baseline to 8 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• University of Texas Health Science Center at San Antonio — San Antonio

Идентификаторы

NCT: NCT07168525 · STUDY00001878

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗