Responsiveness to Acute Changes in Exercise and Relaxation (RACER) Trial (RACER)
2019年4月15日 更新者：Sean Mullen、University of Illinois at Urbana-Champaign
Acute Effects of Aerobic Exercise and Relaxation on Fatigue and Executive Function in Breast Cancer Survivors
The purpose of this acute study is to compare the combined effects of aerobic exercise and relaxation training on fatigue and its related cognitive components, among breast cancer survivors.
Participants will complete three sessions over a seven-day period in a laboratory setting.
研究概览
地位
完全的
条件
详细说明
It is hypothesized that the combination of aerobic exercise and relaxation training could have additive effects on fatigue and related cognitive outcomes. Therefore, this study is designed to test the effects of exercise plus relaxation relative to aerobic exercise alone and relaxation training alone, over the course of three sessions within a seven day period. Participants will complete baseline and post-testing before and after the week of training, as well as pre- and post-testing at each session.
Participants will be randomized to one of three conditions:
- Aerobic Exercise Only Condition (AERO) Participants randomized to the AERO condition will engage in three separate 20-minute sessions comprised of a 5-minute, resistance-free warm-up, and 15 minutes of moderate aerobic cycling on a stationary bike (50-70% age-predicted heart rate max). Each AERO session will end with a 20-minute quiet rest period.
- Relaxation Only Condition (RELAX) Participants in the RELAX condition will complete three separate 20-minute sessions of relaxation training using a commercial neurofeedback device (headset & smartphone app). Each RELAX session will end with a 20-minute quiet rest period.
- Aerobic Exercise and Relaxation Training - Intervention Condition (COMBINED) Participants randomized to the COMBINED condition will complete three separate sessions comprised of 20 minutes of AERO exercise followed by 20 minutes of RELAX training.
All participants, regardless of condition will complete brief questionnaires assessing in-the-moment fatigue and affect, before and after each randomly assigned activity session. A larger survey and battery of cognitive tests will be completed at the beginning of the first appointment and at the conclusion of the third appointment.
研究类型
介入性
注册 (实际的)
40
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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Illinois
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Urbana、Illinois、美国、61801
- University of Illinois at Urbana-Champaign
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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
18年 至 120年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
女性
描述
Inclusion Criteria:
- 18 years and older
- previously diagnosed with breast cancer (ductal carcinoma in situ or stages I-IV)
- completed at least one cycle of chemotherapy treatment within the last 5 years
- must have reliable access to the internet
- must report at least one complaint concerning physical function, fatigue, memory, planning, thinking, negative mood, depressive symptoms, or anxiety
- must be capable of engaging in sustained stationary cycling at a moderate intensity
Exclusion Criteria:
- deaf in both ears
- unable to comfortably wear a pair of ear-bud headphones
- color-blind or do not have vision of at least 20/40 with the aid of contacts or glasses
- history or diagnosis of epilepsy
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：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Aerobic Exercise Only
Participants in the Aerobic Exercise Only arm will engage in three separate 20-minute sessions comprised of a 5-minute, resistance-free warm-up, and 15 minutes of moderate stationary aerobic cycling on a Cybex bike #525C (50-70% age-predicted heart rate max).
Each session will be followed by 20 minutes of uninterrupted quiet rest.
The bike will provide feedback including speed, rotations per minute, and time.
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This intervention will combine 20 minutes of moderate aerobic exercise followed by 20 minutes of quiet rest.
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有源比较器：Relaxation Only
Participants in the Relaxation Only arm will complete three separate 20-minute sessions of relaxation using a commercial wearable neurofeedback (headband) device.
The device's accompanying software (connected to the headband through Bluetooth) encourages breathing strategies in response to recorded brain wave activity.
Real time auditory feedback includes sounds of calm (soft) or loud winds in response to detected brain activity.
A visual report of affective states and the user's brain activity is given (alpha and beta waves).
Participants will also be asked to take part in 20 minutes of uninterrupted quiet rest in order to match the time of the aerobic only condition.
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This intervention will combine 20 minutes of mindfulness-based relaxation training followed by 20 minutes of quiet rest.
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实验性的：Aerobic Exercise and Relaxation
Participants in the Aerobic Exercise and Relaxation arm will complete the three separate 20-minute aerobic exercise sessions (identical to the aerobic exercise only condition) followed by the same 20-minute neurofeedback-guided mindfulness training (identical to the relaxation only condition).
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This intervention will combine 20 minutes of moderate aerobic exercise followed by 20 minutes of mindfulness 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 |
|---|---|---|
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Piper Fatigue Scale
大体时间：This will be assessed on day 1 (baseline), day 2 and day 3 (post-testing), both before and after randomized activities.
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The Piper Fatigue Scale requires respondents to select their answers according to a "0" (most positive or desirable response) to "10" (most negative, fatigue is having a strong impact) scale.
A total fatigue score is calculated by summing each of the 12 responses and dividing by 12. Accordingly, a total fatigue change score of 0 corresponds to no fatigue, a score of 1-3 is labeled as mild, 4-6 is labeled as moderate, and 7-10 is labeled as severe.
The total scores from each of the three days will be used to calculate an overall fatigue score, which will be used to assess group level differences across averages.
Our operational definition of overall fatigue in this outcome is the average score across each group.
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This will be assessed on day 1 (baseline), day 2 and day 3 (post-testing), both before and after randomized activities.
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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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Perceived Mental Fatigue
大体时间：The PMFQ will be assessed on day 1 (baseline), day 2, and day 3 (post-testing).
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The Perceived Mental Fatigue Questionnaire (PMFQ) is a novel inventory using 7-item Likert scale ( e.g., "My thinking requires effort," 1 = Not at all to 5 = Very true).
Participants are asked to reflect on their current level of mental fatigue.
The 7 items from PMFQ are summed together to create a composite fatigue value.
The total scores from each of the three days will be used to calculate an overall fatigue score, which will be used to assess group level differences across averages.
Our operational definition of overall fatigue in this outcome is the average score across each group.
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The PMFQ will be assessed on day 1 (baseline), day 2, and day 3 (post-testing).
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Energy subscale of AD ACL-SAI
大体时间：This will be assessed following randomized activities on Day 1 (baseline), Day 2, and Day 3 (post-testing).
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The AD ACL-SAI asks respondents to select how they relate to a specific adjective in the moment by choosing between 4 answer options (1=not at all, 2=moderately so, 3=somewhat, and 4=very much so).
Each of the 5 items in the Energy subscale are summed together to create an overall Energy fatigue score.The total scores from each of the three days will be used to calculate an overall energy score, which will be used to assess group level differences across averages.
Our operational definition of overall energy in this outcome is the average score across each group.
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This will be assessed following randomized activities on Day 1 (baseline), Day 2, and Day 3 (post-testing).
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Tiredness subscale of AD ACL-SAI
大体时间：This will be assessed following randomized activities on Day 1 (baseline), Day 2, and Day 3 (post-testing).
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The AD ACL-SAI asks respondents to select how they relate to a specific adjective in the moment by choosing between 4 answer options (1=not at all, 2=moderately so, 3=somewhat, and 4=very much so).
Each of the 5 items in the Tiredness subscale are summed together to create an overall Tiredness fatigue score.
This will be used to calculate a change score.
The total scores from each of the three days will be used to calculate an overall tiredness score, which will be used to assess group level differences across averages.
Our operational definition of overall tiredness in this outcome is the average score across each group.
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This will be assessed following randomized activities on Day 1 (baseline), Day 2, and Day 3 (post-testing).
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Attention- Assessed by Flanker Inhibitory Control and Attention task from the NIH toolbox
大体时间：This will be assessed prior to randomized activities on day 1 (baseline), and day 3 (post-testing)
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In the Flanker task participants focus on a given stimulus while inhibiting attention to stimuli flanking it.
Participants see a row of 5 arrows and choose the button that matches the direction the middle arrow is pointing.
This test yields a standardized accuracy and processing speed change score.
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This will be assessed prior to randomized activities on day 1 (baseline), and day 3 (post-testing)
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Working Memory- Assessed by Picture Sequence task from the NIH toolbox
大体时间：This will be assessed prior to randomized activities on day 1 (baseline), and day 3 (post-testing)
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The Picture Sequence tasks asks participants to remember a specific order of events as demonstrated by the task itself on a screen.
At the conclusion of the demonstration, the events are scrambled and the participants are instructed to place them back in the correct order.
This task yields a standardized accuracy change score.
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This will be assessed prior to randomized activities on day 1 (baseline), and day 3 (post-testing)
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Cognitive Flexibility and Attention- Assessed by Dimensional Change Card Sort Task from the NIH toolbox
大体时间：This will be assessed prior to randomized activities on day 1 (baseline), and day 3 (post-testing)
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In the Dimensional Change Card Sort Task, participants are asked to match a series of bivalent test pictures (e.g., yellow balls and blue trucks) to the target pictures, first according to one dimension (e.g., color) and then, after a number of trials, according to the other dimension (e.g., shape).
The ensuing "switch" trials are also employed, in which the participant is required to change the dimension being matched.
For example, after 4 straight trials matching on shape, the participant may be asked to match on color on the next trial and then go back to shape, thus requiring the cognitive flexibility to quickly choose the correct stimulus.
The NIH toolbox automatically calculates an overall raw score, which takes into account both accuracy and reaction time, used to create a change score.
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This will be assessed prior to randomized activities on day 1 (baseline), and day 3 (post-testing)
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Program Evaluation - Perceived Usefulness
大体时间：This will be assessed on day 3.
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All participants will complete an adapted version of Davis (1989) and Davis et al., (1989) perceived usefulness questionnaire (e.g., "Using the technology-delivered relaxation training program improved my thinking").
These 5 items will be measured using a 7-point Likert scale (1 = Strongly disagree, 4 = Neutral, 7 = Strongly agree) and will assess attitudes towards the technology-delivered relaxation-training program.
The 5 item's responses will be averaged and then used for a total perceived usefulness score.
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This will be assessed on day 3.
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Program Evaluation - Perceived Ease of Use
大体时间：This will be assessed on day 3.
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All participants will complete an adapted version of Davis (1989) and Davis et al., (1989) perceived ease of use questionnaire (e.g., "I found the technology-delivered relaxation training program to be easy to use").
These 5 items will be measured using a 7-point Likert scale (1 = Strongly disagree, 4 = Neutral, 7 = Strongly agree) and will assess attitudes towards the technology-delivered relaxation-training program.
The 5 item's responses will be averaged and then used for a total perceived usefulness score.
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This will be assessed on day 3.
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Program Evaluation - Enjoyment
大体时间：This will be assessed on day 3.
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An evaluation of participants' enjoyment of the trial will also be included.
Five questions (e.g., I enjoyed using the mindfulness training device) using a 7-point Likert scale (1 = Not at all, 4 = Neutral, 7 = Completely) will be administered.
The 5 item's responses will be averaged and then used for a total perceived usefulness score.
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This will be assessed on day 3.
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Program Evaluation - Satisfaction
大体时间：This will be assessed on day 3.
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An evaluation of participants' satisfaction with components of the trial will also be included.
Five questions (e.g., I am satisfied with the outcomes experienced following mindfulness training) using a 7-point Likert scale (1 = Not at all, 4 = Neutral, 7 = Completely) will be administered.
The 5 item's responses will be averaged and then used for a total perceived usefulness score.
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This will be assessed on day 3.
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Program Evaluation - Open Ended
大体时间：This will be assessed on day 3.- focusing on thoughts of the program over the three appointment days, in a 1-week period.
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An open ended evaluation of participants' experience with the trial will also be included.
This qualitative question will ask participants to expand upon their overall likes and dislikes, recommendations, and modifications will be included.
Open ended responses will be used to design and apply future interventions in this area.
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This will be assessed on day 3.- focusing on thoughts of the program over the three appointment days, in a 1-week period.
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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。
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 (实际的)
2018年10月15日
初级完成 (实际的)
2019年2月28日
研究完成 (实际的)
2019年2月28日
研究注册日期
首次提交
2018年10月3日
首先提交符合 QC 标准的
2018年10月8日
首次发布 (实际的)
2018年10月11日
研究记录更新
最后更新发布 (实际的)
2019年4月16日
上次提交的符合 QC 标准的更新
2019年4月15日
最后验证
2019年4月1日
更多信息
与本研究相关的术语
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
De-identified participant data will be made available for all primary and secondary outcome measures.
Included documentation will be comprised of study protocol, statistical analyses protocols, informed consent documentation, and layperson research procedures.
Additionally information will be made available upon request.
Data access requests will be reviewed by the primary investigators.
Requestors will be required to sign a Data Access Agreement.
IPD 共享时间框架
Although this is not an NIH funded study, we will update these records within 1 year of data collection completion per NIH guidelines.
IPD 共享访问标准
Data will be accessible on an open site (e.g., Open Science Framework https://osf/io/) with a request to interested parties to engage with the investigative team about any publication of these data in an effort to avoid redundancy.
Appropriate authorship crediting investigators involved in the parent study conceptualization, and any consultation regarding data interpretation should be sought by any researchers interested in publishing these data.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
- 企业社会责任
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.
Aerobic Exercise Only的临床试验
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University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的
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Istanbul UniversityIstanbul University Research Fund完全的
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University of Massachusetts, WorcesterAgency for Healthcare Research and Quality (AHRQ); Omnicare Clinical Research; Qualidigm完全的