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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

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

    • New Mexico
      • Albuquerque、New Mexico、美国、87108
        • New Mexico VA Medical Center and University of New Mexico School of Medicine
    • Texas
      • Houston、Texas、美国、77030
        • Baylor College of Medicine

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

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
实验性的:Diet + Resistance Exercise Training
Weekly behavioral/diet-induced weight loss plus supervised resistance exercise training three times a week
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.
实验性的:Diet + Aerobic Exercise Training
Weekly behavioral/diet-induced weight loss plus supervised aerobic exercise training three times a week
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
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
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
无干预:Control Group (No Diet/No Exercise)
No diet No exercise training

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
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.
6 Months

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
由障碍课程评估
6个月
静平衡的变化
大体时间:6个月
通过单腿姿势评估
6个月
主观功能的变化
大体时间:6个月
通过功能状态问卷评估(得分范围:0-36,得分越高,功能越好)
6个月
情绪变化
大体时间:6个月
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)
6个月
医疗结果的变化 36 项简表健康调查 (SF-36)
大体时间:6个月
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)
6个月
体重对生活质量影响的变化_Lite (IWQOL-lite) 评分
大体时间:6个月
通过 IWQO-liteL 问卷评估
6个月
血脂变化
大体时间:6个月
通过自动酶/比色法评估
6个月
通过问卷评估的习惯性身体活动的变化
大体时间:6个月
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)
6个月
客观测量的习惯性身体活动的变化
大体时间:6个月
使用加速度计
6个月
Change in lean mass
大体时间:6 months
Assessed using dual energy x-ray absorptiometry (DXA)
6 months
Change in fat mass
大体时间:6 months
Assessed using DXA
6 months
Change in muscle strength
大体时间:6 months
Assessed using 1-repetition maximum and dynamometry
6 months
Change in gait speed
大体时间:6 months
Measured as time to walk a certain distance
6 months
Change in areal bone mineral density
大体时间:6 months
Assessed by using DXA
6 months
Change in biochemical marker for bone turnover and bone metabolism
大体时间:6 months
Assessed by using enzyme linked immunoabsorbent assay and radioimmunoassay
6 months
Change in circulating cytokines
大体时间:6 months
Assessed by using enzyme linked immunoassay
6 months
Change in adipocytokines
大体时间:6 months
Assessed by using enzyme linked immunoassay
6 months
Change in aerobic capacity
大体时间:6 months
Assessed by using indirect calorimetry during graded exercise stress test
6 months
Change in systolic and diastolic blood pressure
大体时间:6 months
Assessed by using sphygmomanometer
6 months
Change in serum glucose
大体时间:6 months
Assessed by glucose oxidase method
6 months
Change in serum insulin
大体时间:6 months
Assessed by immunoassay
6 months
Change in serum estradiol
大体时间:6 months
Assessed by immunoassay
6 months
Change in 25 hydroxyvitamin D
大体时间:6 months
Assessed by immunoassay
6 months
Change in gene expression of muscle anabolic and catabolic factors
大体时间:6 months
Assessed by reverse transcription polymerase chain reaction and nanostring
6 months
Change in protein expression of muscle anabolic and catabolic factors
大体时间:6 months
Assessed by western blotting
6 months
Change in concentration of targeted metabolites
大体时间:6 months
Assessed by liquid chromatography hyphenated with mass spectrometry techniques
6 months
Change in modified mini-mental exam
大体时间:6 months
Assessed by using cognitive instrument testing
6 months
Change in word fluency
大体时间:6 months
Assessed by using cognitive instrument testing
6 months
Change in trail a and trail b
大体时间:6 months
Assessed by using cognitive instrument testing
6 months
Change in Ray Auditory verbal learning test
大体时间:6 months
Assessed by using cognitive instrument testing
6 months
Change in muscle protein synthesis rate
大体时间:6 months
Assessed by stable isotope methodology
6 months
Change in thigh muscle and fat mass
大体时间:6 months
Assessed by magnetic resonance imaging (MRI)
6 months
Change in visceral fat mass
大体时间:6 months
Assessed by MRI
6 months
Change in waist circumference
大体时间:6 months
Using a tape measure
6 months
Change in serum testosterone
大体时间:6 months
Assessed by immunoassay
6 months
Change is serum sclerostin
大体时间:6 months
Assessed by immunoassay
6 months
Change in parathyroid hormone
大体时间:6 months
Assessed by immunoassay
6 months

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。

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

3
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