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Improving Muscle for Functional Independence Trial (I'MFIT)

2018年7月30日 更新者：Wake Forest University
Aging is associated with declines in muscle strength, power, and overall functional ability that lead to disability and loss of independence. Furthermore, the existing high prevalence of obesity in the elderly is greatly exacerbating these aging-related declines in function. To date, regular exercise, especially resistance exercise, is the only known treatment to consistently improve muscle function and perhaps delay the onset of disability. However, not all individuals experience the same magnitude of benefit from a given exercise stimulus, and accumulating data show that obesity limits muscle adaptations to chronic exercise.Therefore, the proposed study is designed to determine the effects of caloric restriction on improvements in skeletal muscle function in response to RT.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Design Overview:

This is a 5-month randomized trial in 130 older, overweight or obese, sedentary men and women. Phase 1 involves recruitment and screening followed by baseline research testing (Phase 2). Next, subjects will be randomly assigned to one of two 5-month treatments (Phase 3): RT intervention alone (RT) or to an RT with caloric restriction (RT+CR) intervention. Subjects will return for visits the completion of their 5 month intervention. A subset of participants (n=30) will return for an 18 month follow up.

Interventions:

Resistance training+ Caloric Restriction:Participants assigned to RT+CR group will be instructed to follow a hypocaloric diet (-600 kcal/d) for 20 weeks, as well as the resistance training program noted below.In addition, all participants will be provided with a daily calcium (1200 mg/d) and vitamin D (800 IU/d) supplement.The intervention will incorporate meal replacements, nutrition education, and lifestyle behavior modifications.

Resistance training: The maximal weight that can be lifted with correct form in a single repetition (1RM) will be used to prescribe intensity. Strength testing will be repeated every 4 wks and the training loads adjusted so that they are consistent with the 70% 1RM goal. Participants will exercise 3 d/wk on Nautilus resistance machines, under the supervision of two exercise leaders who are trained in basic life support and in emergency management procedures. All exercise will take place at Wake Forest University's Department of Health and Exercise Science Clinical Research Center (CRC). Participants will exercise in small groups which will allow a rotation/rest between machines and enhance the social environment. Heart rate and blood pressure will be measured before and after each session. Subjects will warm-up by walking or cycling for 5 minutes at a slow pace followed by large muscle flexibility exercises. The interventionists will ensure that participants adjust the equipment appropriate to their body size and complete the exercises with correct form. Training sessions will end with a cool-down by walking or cycling for 5 minutes at a slow pace followed by light stretching.

研究类型

介入性

注册 (实际的)

126

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

  • 美国
    • North Carolina
      • Winston-Salem、North Carolina、美国、27157
        • Wake Forest University Health Sciences

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 79年 (年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • BMI=27-34.9 kg/m2
  • No resistance training for past 6 mos
  • Normal cognitive function (MMSE >24)
  • No contraindications for participation in weight loss or resistance exercise including severe arthritis or musculoskeletal disorders, knee or hip replacement or spinal surgery in past year
  • No broken bones in the past 6 months
  • Able to provide own transportation to study visits and intervention
  • Not involved in any other research study and not undergoing physical therapy
  • Not dependent on a cane or walker

Exclusion Criteria:

  • Weight loss or gain (±5%) in past 6 months
  • Body mass >136 kg (DXA limit)
  • Current smoker (No nicotine within past year) or evidence of alcohol or drug abuse
  • Insulin dependent or uncontrolled diabetes (FBG >140 mg/dL)
  • Uncontrolled hypertension (BP>180/100 mmHg)
  • Abnormal kidney function or liver blood tests
  • Past or current cardiovascular disease, including uncontrolled angina or dysrhythmia, hypertrophic cardiomyopathy, congestive heart failure, PAD, stroke, history of myocardial infarction, use of defibrillator or major heart surgery, or deep vein thrombosis or pulmonary embolus
  • Past or current respiratory disease (requiring steroid treatment or supplemental oxygen)
  • Past or current clinical diagnoses of neurological or hematological disease
  • Use of any medications that could influence study variables (growth/steroid hormones, prescription anti-inflammatory medications, or beta blockers, Coumadin or any other blood thinner, including Plavix, Ticid, and Aggrenox)
  • Cancer requiring treatment in past 2 years, except non-melanoma skin cancers
  • Clinically evident edema or anemia

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
有源比较器：1. Resistance Training
3 d/wk resistance training
行为的：Resistance Training
3 d/wk resistance training
其他名称：
  • 转播
  • Nautilus resistance machines
实验性的：2. Resistance Training + Diet
Resistance training plus caloric restriction
行为的：Resistance Training + Diet
3 d/w resistance training plus 600 kcal/d deficit
其他名称：
  • RT+CR

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Skeletal muscle function (muscle quality and muscle power) and overall physical function (SPPB score)
大体时间：5 month study with baseline and 5 and 18 month follow up assessment visits
5 month study with baseline and 5 and 18 month follow up assessment visits

次要结果测量

结果测量
大体时间
single-fiber contractile force and power, intramyocellular lipid (IMCL), muscle gene and protein expression of interleukin-6 (IL-6) and tumor necrosis factor alpha.
大体时间：baseline and 5 and 18-month follow-up
baseline and 5 and 18-month follow-up

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。

赞助

Wake Forest University

调查人员

  • 首席研究员：Barbara J Nicklas, PhD、Wake Forest University Health Sciences

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

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)

2014年5月1日

研究完成 (实际的)

2014年5月1日

研究注册日期

首次提交

2010年1月11日

首先提交符合 QC 标准的

2010年1月13日

首次发布 (估计)

2010年1月14日

研究记录更新

最后更新发布 (实际的)

2018年8月1日

上次提交的符合 QC 标准的更新

2018年7月30日

最后验证

2018年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IRB00009098

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

All data will be made available upon email request to the study PI and upon completion of a data-sharing agreement. This agreement will require that data be used only for research purposes, that no attempts be made to identify individual patients, that the data will be kept secure, that the user will not distribute the data to other researchers, that the user will return the files or destroy them once the project is completed, and that the user will acknowledge the data source. All data files will be de-identified. In addition, variables that could permit linkages to individual research participants and variables that could lead to deductive disclosure of the identity of individual subjects will be removed or recoded. We will create a link on our website that describes our study and the data available for data sharing with descriptions.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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赞助者和合作者

医疗条件

药物干预

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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