Lifestyle Intervention Trial in Obese Elderly (LITOE)
2020年1月17日 更新者:Dennis Villareal、Biomedical Research Institute of New Mexico
Exercise Interventions During Voluntary Weight Loss in Obese Older Adults
Obesity causes frailty in obese older adults by exacerbating the age-related decline in physical function.
However, appropriate management of obesity in older adults is controversial.
Weight loss without exercise could worsen frailty by accelerating the usual age-related decline in muscle and bone mass that leads to sarcopenia and osteopenia, respectively.
Because of the important problem of frailty in obese older adults, it is important to determine the most efficacious approach in reducing, or even reversing frailty in this population.
The primary objective of this proposal is to evaluate which distinct type of physical exercise (resistance, aerobic, or combined resistance + aerobic) is most efficacious in preventing the weight-loss-induced reduction in muscle and bone mass and reversing frailty in obese older adults.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
160
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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New Mexico
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Albuquerque、New Mexico、美国、87108
- New Mexico VA Medical Center and University of New Mexico School of Medicine
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Texas
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Houston、Texas、美国、77030
- Baylor College of Medicine
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
65年 至 85年 (年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 65-85 years old
- Obese men and women (BMI > or equal to 30 kg/m2)
- Stable weight (±2 kg) during the last 6 mos.
- Must be sedentary (regular exercise <1 h/wk or <2 x/wk for the last 6 mos.)
- Be judged, during the initial screening, to be well motivated and reliable
Exclusion Criteria:
- Any major chronic diseases
- Any condition or unstable diseases that would interfere with exercise or dietary restriction, in which exercise or dietary restriction are contraindicated, or that would interfere with interpretation of results that include but are not limited to:
- Cardiopulmonary disease (e.g., recent MI, unstable angina, stroke etc.)
- Severe orthopedic/musculoskeletal or neuromuscular impairments that would contraindicate participation in exercise
- Visual or hearing impairments that interfere with following directions
- Diagnosis of dementia
- History of malignancy during the past 5 yr
- Recent use of bone acting drugs (e.g. use of estrogen, or androgen containing compound, raloxifene, calcitonin, parathyroid hormone during the past year or biphosphonates during the last two years)
- Individuals on insulin or with a fasting blood glucose of > 140mg/dl, and/or a 2 hour post-glucose of >250 mg/dl
- BMD t-scores of <-2.3 of the lumbar spine and proximal femur
- serum creatinine >2.0 mg/dl
- No commitments, life situations or conditions that would interfere with their participation in the study
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Diet + Resistance Exercise Training
Weekly behavioral/diet-induced weight loss plus supervised resistance exercise training three times a week
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Behavioral Therapy through a lifestyle modification program, Diet therapy once weekly through a dietician prescribed diet for 26 weeks, and resistance exercise training 3-days/week for 24 weeks.
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实验性的:Diet + Aerobic Exercise Training
Weekly behavioral/diet-induced weight loss plus supervised aerobic exercise training three times a week
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Behavioral Therapy through a lifestyle modification program, Diet therapy once weekly through a dietician prescribed diet for 26 weeks, and aerobic exercise training 3-days/week for 24 weeks
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实验性的:Diet + Combined Aerobic/Resistance Exercise
Weekly behavioral/diet-induced weight loss plus combined supervised resistance exercise training and aerobic exercise training three times a week
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Behavioral Therapy through a lifestyle modification program, Diet therapy once weekly through a dietician prescribed diet for 26 weeks, and combined resistance/aerobic exercise training 3-days/week for 24 weeks
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无干预:Control Group (No Diet/No Exercise)
No diet No exercise training
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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 |
---|---|---|
Change in Physical Function
大体时间:6 Months
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The Physical Performance Test includes seven standardized tasks (walking 15.2 m [50 ft], putting on and removing a coat, picking up a penny, standing up from a chair, lifting a book, climbing one flight of stairs, and performing a progressive Romberg test) plus two additional tasks (going up and down four flights of stairs and making a 360-degree turn).
The score for each task ranges from 0 to 4, with higher scores indicating better physical performance; a perfect score would be 36.
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6 Months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
动态平衡的变化
大体时间:6个月
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由障碍课程评估
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6个月
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静平衡的变化
大体时间:6个月
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通过单腿姿势评估
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6个月
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主观功能的变化
大体时间:6个月
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通过功能状态问卷评估(得分范围:0-36,得分越高,功能越好)
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6个月
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情绪变化
大体时间:6个月
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通过老年抑郁量表评估(分数范围:0至30分,分数越低表示情绪越好)
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6个月
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医疗结果的变化 36 项简表健康调查 (SF-36)
大体时间:6个月
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由身体部分总分和心理部分总分评估(分数范围0至100分,分数越高表明健康状况越好)
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6个月
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体重对生活质量影响的变化_Lite (IWQOL-lite) 评分
大体时间:6个月
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通过 IWQO-liteL 问卷评估
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6个月
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血脂变化
大体时间:6个月
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通过自动酶/比色法评估
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6个月
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通过问卷评估的习惯性身体活动的变化
大体时间:6个月
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使用斯坦福体力活动问卷(分数范围:0至40分,分数越高表示体力活动水平越高)
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6个月
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客观测量的习惯性身体活动的变化
大体时间:6个月
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使用加速度计
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6个月
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Change in lean mass
大体时间:6 months
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Assessed using dual energy x-ray absorptiometry (DXA)
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6 months
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Change in fat mass
大体时间:6 months
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Assessed using DXA
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6 months
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Change in muscle strength
大体时间:6 months
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Assessed using 1-repetition maximum and dynamometry
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6 months
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Change in gait speed
大体时间:6 months
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Measured as time to walk a certain distance
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6 months
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Change in areal bone mineral density
大体时间:6 months
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Assessed by using DXA
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6 months
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Change in biochemical marker for bone turnover and bone metabolism
大体时间:6 months
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Assessed by using enzyme linked immunoabsorbent assay and radioimmunoassay
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6 months
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Change in circulating cytokines
大体时间:6 months
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Assessed by using enzyme linked immunoassay
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6 months
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Change in adipocytokines
大体时间:6 months
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Assessed by using enzyme linked immunoassay
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6 months
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Change in aerobic capacity
大体时间:6 months
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Assessed by using indirect calorimetry during graded exercise stress test
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6 months
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Change in systolic and diastolic blood pressure
大体时间:6 months
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Assessed by using sphygmomanometer
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6 months
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Change in serum glucose
大体时间:6 months
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Assessed by glucose oxidase method
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6 months
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Change in serum insulin
大体时间:6 months
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Assessed by immunoassay
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6 months
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Change in serum estradiol
大体时间:6 months
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Assessed by immunoassay
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6 months
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Change in 25 hydroxyvitamin D
大体时间:6 months
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Assessed by immunoassay
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6 months
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Change in gene expression of muscle anabolic and catabolic factors
大体时间:6 months
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Assessed by reverse transcription polymerase chain reaction and nanostring
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6 months
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Change in protein expression of muscle anabolic and catabolic factors
大体时间:6 months
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Assessed by western blotting
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6 months
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Change in concentration of targeted metabolites
大体时间:6 months
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Assessed by liquid chromatography hyphenated with mass spectrometry techniques
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6 months
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Change in modified mini-mental exam
大体时间:6 months
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Assessed by using cognitive instrument testing
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6 months
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Change in word fluency
大体时间:6 months
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Assessed by using cognitive instrument testing
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6 months
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Change in trail a and trail b
大体时间:6 months
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Assessed by using cognitive instrument testing
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6 months
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Change in Ray Auditory verbal learning test
大体时间:6 months
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Assessed by using cognitive instrument testing
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6 months
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Change in muscle protein synthesis rate
大体时间:6 months
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Assessed by stable isotope methodology
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6 months
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Change in thigh muscle and fat mass
大体时间:6 months
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Assessed by magnetic resonance imaging (MRI)
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6 months
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Change in visceral fat mass
大体时间:6 months
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Assessed by MRI
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6 months
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Change in waist circumference
大体时间:6 months
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Using a tape measure
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6 months
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Change in serum testosterone
大体时间:6 months
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Assessed by immunoassay
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6 months
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Change is serum sclerostin
大体时间:6 months
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Assessed by immunoassay
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6 months
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Change in parathyroid hormone
大体时间:6 months
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Assessed by immunoassay
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6 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Dennis T Villareal, MD FACP FACE、Baylor College of Medicine
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Armamento-Villareal R, Aguirre L, Waters DL, Napoli N, Qualls C, Villareal DT. Effect of Aerobic or Resistance Exercise, or Both, on Bone Mineral Density and Bone Metabolism in Obese Older Adults While Dieting: A Randomized Controlled Trial. J Bone Miner Res. 2020 Mar;35(3):430-439. doi: 10.1002/jbmr.3905. Epub 2019 Dec 4.
- Colleluori G, Aguirre L, Phadnis U, Fowler K, Armamento-Villareal R, Sun Z, Brunetti L, Hyoung Park J, Kaipparettu BA, Putluri N, Auetumrongsawat V, Yarasheski K, Qualls C, Villareal DT. Aerobic Plus Resistance Exercise in Obese Older Adults Improves Muscle Protein Synthesis and Preserves Myocellular Quality Despite Weight Loss. Cell Metab. 2019 Aug 6;30(2):261-273.e6. doi: 10.1016/j.cmet.2019.06.008. Epub 2019 Jul 3.
- Villareal DT, Aguirre L, Gurney AB, Waters DL, Sinacore DR, Colombo E, Armamento-Villareal R, Qualls C. Aerobic or Resistance Exercise, or Both, in Dieting Obese Older Adults. N Engl J Med. 2017 May 18;376(20):1943-1955. doi: 10.1056/NEJMoa1616338.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年2月1日
初级完成 (实际的)
2016年1月1日
研究完成 (实际的)
2018年12月31日
研究注册日期
首次提交
2010年2月8日
首先提交符合 QC 标准的
2010年2月8日
首次发布 (估计)
2010年2月9日
研究记录更新
最后更新发布 (实际的)
2020年1月22日
上次提交的符合 QC 标准的更新
2020年1月17日
最后验证
2020年1月1日
更多信息
与本研究相关的术语
其他研究编号
- R01AG031176 (美国 NIH 拨款/合同)
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Diet + Resistance Training的临床试验
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Karolinska InstitutetMinistry of Health and Social Affairs, Sweden完全的
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Rush University Medical CenterUniversity of Chicago; National Institute on Aging (NIA); Advocate Hospital System招聘中