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Physical Activity, Fatigue, Sleep, and Inflammation (ABLE)

2016年3月7日 更新者:University of Alabama at Birmingham

Physical Activity Benefits After Breast Cancer: Exploring Cytokine Mechanisms

The purpose of the study is to examine the benefits of physical activity for breast cancer survivors related to muscle strength, tiredness, and sleep quality. Also, the study will determine the potential role of inflammation in these benefits.

研究概览

详细说明

Our previous research has shown that increases in physical activity can improve the health and well-being of breast cancer survivors. The current study will determine whether the physical activity increases are adequate for improved health by measuring physical activity (accelerometer and self-report), muscle strength, fatigue, and sleep. Moreover, few studies have examined cytokine changes in cancer survivors after participation in a physical activity behavior change intervention with a mechanistic focus on cytokines which may influence the muscle strength, fatigue, and sleep response to the intervention.

Seventy-four female, breast cancer survivors are being recruited within a 50-miles radius of Springfield, IL. Participants will be in the study for approximately 5 months. Participants will be asked to complete a questionnaire at the beginning of the study and 3 months later. A blood sample will be drawn to determine serum cytokine levels.

Volunteers will be randomly assigned to 1 of 2 study groups. The intervention group will participate in a 3 month physical activity intervention involving moderate intensity walking and strength training with resistance bands.

This randomized controlled trial includes the following study aims:

Study aim 1: The intervention group will be compared with the control group to examine the change in physical activity, muscle strength, fatigue, and sleep dysfunction before and after participation in a physical activity intervention.

Study aim 2: To investigate mechanisms that may underlie the effects of the physical activity intervention on muscle strength, fatigue, and sleep, we will compare the intervention group with the control group in terms of changes in cytokine markers of inflammation and evaluate whether such changes are consistent with and may mediate changes in muscle strength, fatigue, and sleep dysfunction.

研究类型

介入性

注册 (实际的)

49

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

    • Illinois
      • Springfield、Illinois、美国、62702
        • Southern Illinois University School 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

30年 至 70年 (成人、年长者)

接受健康志愿者

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Female, 30 to 70 years of age, with first diagnosis of ductal carcinoma in situ (DCIS) or Stage I or Stage II breast cancer
  • If chemotherapy or radiation therapy was received, the patient must be at least 4 weeks status post final primary treatment administration to allow treatment related cytokine changes to resolve. The participant may be taking longer term therapies such as aromatase inhibitors, estrogen receptor modulators, etc.
  • If the patient has undergone a surgical procedure, she must be at least 8 weeks post-procedure.
  • English speaking
  • Medical clearance for participation provided by primary care physician or oncologist
  • Postmenopausal
  • Average fatigue over the past week of ≥ 3 on a 1 to 10 Likert scale or sleep dysfunction ≥ 1 on a 0 to 3 Likert scale
  • Participating, on average, in no more than 20 minutes of physical activity on two or fewer days per week during the past six months
  • Willing to abstain from "as needed" medications for 7 days prior to each blood draw. "As needed" medications are defined as any medicine (prescription or over-the-counter) that is taken sporadically as needed for specific complaints rather than taken at regularly scheduled intervals (e.g., daily).

Exclusion Criteria:

  • Metastatic or recurrent breast cancer
  • Inability to ambulate without assistance
  • Unstable angina
  • New York Heart Association class II, III, or IV congestive heart failure
  • Uncontrolled asthma
  • Interstitial lung disease
  • Current use of steroids
  • Having been told by a physician to only do exercise prescribed by a physician
  • Dementia or organic brain syndrome
  • Schizophrenia or active psychosis
  • Connective tissue or rheumatologic disease [i.e., Systemic lupus erythematosus, rheumatoid arthritis, amyloidosis, Reiter's syndrome, psoriatic arthritis, mixed connective tissue disease, Sjögren's syndrome, progressive systemic sclerosis, CREST syndrome, polymyositis, dermatomyositis, vasculitis, polymyalgia rheumatic, temporal arteritis]
  • Anticipates undergoing elective surgery during the duration of the intervention which would interfere with intervention participation (e.g., breast reconstructive surgery).
  • Do not live or work less than 50 miles from the study site
  • Lack of transportation to the study site
  • Changes in usual medications expected during the study time period
  • Plan to move residence out of the local area during the 5 months of the study
  • Plan to travel out of the local area for vacation during the first 4 weeks of the intervention or plan to travel out of the local area for more than a week during the last 8 weeks of the intervention
  • Contraindication to participation in physical activity (i.e., moderate intensity walking and strength training with resistance bands)

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:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预:Control
no physical activity intervention
实验性的:Exercise intervention
3 month physical activity intervention involving moderate intensity walking and strength training with resistance bands
3 month physical activity intervention involving moderate intensity walking and strength training with resistance bands
其他名称:
  • 锻炼

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
physical activity
大体时间:baseline and 3 months
The intervention group will be compared with the control group to examine the change in physical activity, before and after participation in a physical activity intervention. Participants are in the study for approximately 5 months. Assessments will be conducted at baseline, and following the 3 month exercise intervention.
baseline and 3 months
muscle strength
大体时间:baseline and 3 months
The intervention group will be compared with the control group to examine the change in muscle strength before and after participation in a physical activity intervention.
baseline and 3 months
fatigue
大体时间:baseline and 3 months
The intervention group will be compared with the control group to examine the change in fatigue before and after participation in a physical activity intervention.
baseline and 3 months
sleep dysfunction
大体时间:baseline and 3 months
The intervention group will be compared with the control group to examine the change in sleep dysfunction before and after participation in a physical activity intervention.
baseline and 3 months

次要结果测量

结果测量
措施说明
大体时间
inflammatory markers (serum cytokine levels)
大体时间:baseline and 3 months
The study will also examine whether changes in inflammatory markers mediate improvements in the outcome measures of muscle strength, fatigue, and sleep dysfunction. Blood samples with no potential for extraction of DNA will be collected.
baseline and 3 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。

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8月1日

初级完成 (实际的)

2013年12月1日

研究完成 (实际的)

2013年12月1日

研究注册日期

首次提交

2010年6月17日

首先提交符合 QC 标准的

2010年6月17日

首次发布 (估计)

2010年6月22日

研究记录更新

最后更新发布 (估计)

2016年3月8日

上次提交的符合 QC 标准的更新

2016年3月7日

最后验证

2016年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • ROG-SCCI-10-004-1
  • R21CA135017-01A2 (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.

3 month physical activity intervention的临床试验

3
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