衰老的生物学机制对老年人抵抗训练的反应变异性的影响 (BRIO)
衰老的生物学机制对老年人抗性训练的反应变异性（BRIO）的影响：一项随机的，安慰剂对照的老年人进行性耐药性训练试验。
To critically examine biological, clinical, and behavioral modulators of progressive resistance training-associated exercise response heterogeneity in physical function and whole-body metabolism in older adults.
研究概览
详细说明
A 6-month, single blind, randomized, controlled multi-center clinical trial comparing a Health Education control intervention to a supervised Progressive Resistance Training intervention to test the central hypothesis that biological mechanisms of aging are mediators of exercise response heterogeneity in older adults.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Amanda Tweed
- 电话号码：507-255-6663
- 邮箱：tweed.amanda@mayo.edu
学习地点
-
-
Massachusetts
-
Boston、Massachusetts、美国、02111
- 招聘中
- Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University
-
首席研究员：
- Roger Fielding, PhD
-
接触：
- Arion Mete
- 电话号码：617-556-3237
- 邮箱：arion.mete@tufts.edu
-
-
Minnesota
-
Rochester、Minnesota、美国、55905
- 招聘中
- Mayo Clinic
-
接触：
- Amanda Tweed
- 电话号码：507-255-6663
- 邮箱：tweed.amanda@mayo.edu
-
首席研究员：
- Nathan LeBrasseur, Ph.D, MS
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- aged greater than or equal to 65 years
- sedentary (Community Healthy Activities Model Program for Seniors physical activity questionnaire to identify and exclude persons engaged in regular (125 min/week or more) moderate intensity physical activity
- at risk for mobility disability score of less than or equal to 10 (but greater than 3) on the SPPB
- willing to be randomized into HE or PRT
- willing to be transported or transport themselves to the clinical sites for the intervention and assessments
Exclusion Criteria:
- unwillingness to provide informed consent
- participation in lifestyle or pharmacologic intervention trial or structured program of exercise training in the past 6 months
- an SPPB score of less than or equal to 3
- osteoarthritis or condition with joint pain limiting daily life activities
- significant weight loss or gain (7.5% of body weight) in past six months
- current anti-coagulant or anti-platelet therapy (Coumadin, Eliquis, Pradaxa, Xarelto, heparin, Lovenox, Plavix)
- clinically significant abnormality in any of the screening laboratory values, including those identified as outside of the "normal limits', that are deemed to be of concern for participation in the study by the study physician
- acute or terminal illness
- Mini Mental State Exam (MMSE) <23
- myocardial infarction in the previous 6 months or other symptomatic coronary artery disease
- New York Heart Association Class III or IV congestive heart failure
- serious conduction disorder (e.g., 3rd degree heart block), uncontrolled arrhythmia, or new Q waves or ST-segment depressions (>3 mm) on ECG
- chronic obstructive pulmonary disease requiring oxygen therapy
- upper or lower extremity fracture in the previous 6 months
- uncontrolled hypertension (150/90 mm Hg)
- neuromuscular diseases and/or drugs which affect neuromuscular function
- current use of anabolic steroids, growth hormone, replacement androgen therapy, anti-androgen therapy
- allergy to lidocaine
- presence of significant liver or renal disease (eGFR < 45 mL/min)
- diagnosis of type I diabetes mellitus or insulin requiring type 2 diabetes mellitus
- HbA1c > 7%
- BMI <21 or >35 for men or >40 for women
- excessive alcohol intake (>14 alcoholic beverages per wk.)
- current tobacco use
- current participation in any interventional clinical trial
- current use of weight loss medications
学习计划
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Progressive Resistance Training
participants will attend exercise session 3 times per week. |
3 times a week |
|
其他：Health Education
participants will attend health educations classed 1 time per week. |
once a week |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Precisely define the variability in changes in physical function
大体时间：baseline, 6 months
|
Measured by the Short Physical Performance Battery (SPPB), a 0-12 categorical scale of walking speed, standing balance, and repeated sit-to-stand time, with higher scores reflecting better physical function. |
baseline, 6 months
|
|
Precisely define the variability in changes in blood glucose concentrations in response to a meal tolerance test
大体时间：baseline, 6 months
|
Blood glucose concentrations (millimoles/liter) will be measured in response to a physiologically relevant meal challenge. Lower values are indicative of better metabolic health. |
baseline, 6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Precisely define the variability in changes in skeletal muscle size.
大体时间：baseline, 6 months
|
Measured by computed tomography scans of the mid-thigh. Larger muscle cross-sectional area (cm^2) reflects a greater quantity of skeletal muscle. |
baseline, 6 months
|
|
Precisely define the variability in changes in skeletal muscle strength.
大体时间：baseline, 6 months
|
Measured by the one-repetition maximum, in newtons, on a leg press device, with higher scores reflecting greater skeletal muscle strength. |
baseline, 6 months
|
|
Precisely define the variability in changes in six-minute walk distance.
大体时间：baseline, 6 months
|
Measured by the distance (meters) walked in six minutes, with longer distances reflecting better physical function. |
baseline, 6 months
|
|
Precisely define the variability in insulin secretion in response to a mixed meal tolerance test.
大体时间：baseline, 6 months
|
Blood insulin concentrations (pmol/L) will be measured in response to a physiologically relevant meal challenge. Insulin concentrations in a physiological range reflect better metabolic health, while low insulin concentrations can reflect an impaired insulin response and high insulin concentrations can reflect peripheral insulin resistance. |
baseline, 6 months
|
|
Precisely define the variability in changes in the percentage of glycated hemoglobin in the blood.
大体时间：baseline, 6 months
|
Measured by the percentage of glycated hemoglobin in the blood (often referred to as HbA1c). A lower percentage of HbAlc reflects lower blood glucose concentrations over the past two to three months. |
baseline, 6 months
|
|
Precisely define the variability in changes in blood lipids.
大体时间：baseline, 6 months
|
Blood lipids, including total cholesterol, low density lipoproteins (LDLs), high density lipoproteins (HDLs), and triglycerides will be measured. Lower levels of total cholesterol (mg/dL), LDLs (mg/dL), and triglycerides (mg/dL), and higher levels of HDLs (mg/dL), are reflective of better metabolic health. |
baseline, 6 months
|
|
Precisely define the variability in changes in waist-to-hip ratio.
大体时间：baseline, 6 months
|
The circumference (cm) of the waist and hips will be measured and a ratio will be calculated. A lower waist-to-hip ratio is reflective of a better body composition (less central obesity or visceral fat). |
baseline, 6 months
|
合作者和调查者
赞助
合作者
调查人员
- 首席研究员：Nathan LeBrasseur, Ph.D, MS、Mayo Clinic
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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