Exercise in Improving Mobility and Reducing Fatigue and/or Weakness in Older Cancer Survivors
A RENEW Intervention for Elderly Cancer Survivors
RATIONALE: Exercise may help improve mobility and relieve fatigue and/or weakness in cancer survivors. It is not yet known whether exercise is more effective than standard therapy in improving mobility and reducing fatigue and/or weakness in older cancer survivors.
PURPOSE: This randomized clinical trial is studying exercise to see how well it works compared to standard therapy in improving mobility and reducing fatigue and/or weakness in older cancer survivors.
研究概览
地位
详细说明
OBJECTIVES:
- Compare the perception of, and the patterns of change in fatigue, weakness, physical activity level, and functional status in elderly cancer survivors who undergo Resistance Exercise via Negative-Eccentric Work (RENEW) vs standard care.
- Compare changes in muscle structure, function (strength + power production and metabolic function) and mobility.
- Evaluate the patient's adherence to and satisfaction with the RENEW intervention.
OUTLINE: This is a prospective, randomized, controlled, longitudinal study. Patients are randomized to 1 of 2 intervention arms.
- Arm I: Patients undergo resistance exercise via negative-eccentric work (RENEW), using a special seated stationary leg exercise machine, 3 times a week for up to 12 weeks. Exercise exertion and duration is gradually increased weekly for the first 4-5 weeks of RENEW.
- Arm II: Patients receive standard care. In both arms, fatigue, weakness, physical activity, functional status, muscle structure and function, and mobility are assessed at baseline and then at 12 weeks after completion of study intervention. Fatigue and weakness are also assessed weekly during study intervention. Patients in arm I also undergo isometric strength assessment weekly during RENEW and assessment of adherence to and satisfaction with RENEW at 12 weeks after completion of RENEW.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Utah
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Salt Lake City、Utah、美国、84112
- Huntsman Cancer Institute at University of Utah
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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
DISEASE CHARACTERISTICS:
- Survivor of breast, prostate, colon, lung, lymphoma, ovarian, bladder, or esophageal cancer with no evidence of disease
- At least moderate levels of fatigue and/or weakness
Impaired mobility but ambulatory and medically able to participate in an exercise regimen
- No impaired knee flexion, defined as < 90º
PATIENT CHARACTERISTICS:
- Folstein Mini-Mental Status Examination score ≥ 23
- No extreme claustrophobia
- No diagnosed chronic fatigue syndrome/disorder
No neurological impairments, including the following:
- Central nervous system disorder (e.g., multiple sclerosis or Parkinson's disease)
- Neurological insult (cerebrovascular attack) that manifests in a mobility disorder
- No myopathic disease (e.g., focal myopathy) that effects skeletal muscle structure/function
- No rheumatological disease that has an effect on muscle and/or mobility (e.g., polymyalgia rheumatica)
PRIOR CONCURRENT THERAPY:
More than 6 months since prior regular aerobic or resistance exercise
- Regular exercise defined as 2-3 times per week
- At least 6 months since prior cancer treatment (surgery, radiation, and/or chemotherapy )
- No concurrent cancer-related treatment other than hormonal therapy
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
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 |
|---|---|---|
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Patient perception and pattern of change
大体时间：3 months of training followed by 6 and 12 months of no formal training
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To explore the participant's perception and pattern of change in fatigue, weakness, physical activity level and functional status
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3 months of training followed by 6 and 12 months of no formal training
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Structural and function changes
大体时间：3 months of training followed by 6 and 12 months of no formal training
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To explore whether changes in muscle structure and function (strength and power production and metabolic function) and mobility occur following twelve weeks of training with RENEW
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3 months of training followed by 6 and 12 months of no formal training
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合作者和调查者
调查人员
- 首席研究员：Paul C. LaStayo, PhD, PT、University of Utah
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 14551
- P30CA042014 (美国 NIH 拨款/合同)
- R21CA114523 (美国 NIH 拨款/合同)
- UUMC-R21CA114523
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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.
exercise intervention的临床试验
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University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动，不招人
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动，不招人