Effects of Ultrasound on Healthy Aging
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Knee Extension Strength change
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
This sham-controlled design improves internal validity by minimizing placebo effects and allows for participant blinding, as the ultrasound is inaudible and imperceptible.
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Spa Only Group without ultrasound
Sessions will take place three times per week, with spa immersion with no ultrasound lasting 45 minutes each, for a total of eight weeks.
干预措施: Sham ultrasound spa (Other)
Ultrasound Spa Group
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.
干预措施: Ultrasound spa (Device)
结局指标
主要结局
Knee Extension Strength change
时间窗: 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.
Knee Extension Strength change
时间窗: 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.
次要结局
- Change in Short Physical Performance Battery (SBBP)(Baseline to 8 weeks)
- Change in Senescence(Baseline to 8 weeks)
- Change in immune aging(Baseline to 8 weeks)
- Change in Short Physical Performance Battery (SBBP)(Baseline to 8 weeks)
- Change in Timed Up and Go (TUG)(Baseline to 8 weeks)
- Change in 6 minute walk distance(Baseline to 8 weeks)
- Change in Senescence(Baseline to 8 weeks)
- Change in immune aging(Baseline to 8 weeks)
- Change in cognitive function(Baseline to 8 weeks)
- Change in lean body mass(Baseline to 8 weeks)
- Change in fat mass(Baseline to 8 weeks)
研究者
Blake Rasmussen
Professor and Chairman of Dept. of Cellular & Integrative Physiology
The University of Texas Health Science Center at San Antonio