Acute Effects of Aerobic Exercise and Relaxation on Fatigue and Executive Function in Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Piper Fatigue Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Aerobic Exercise Only (Behavioral)
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.
干预措施: Relaxation Only (Behavioral)
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).
干预措施: Aerobic Exercise and Relaxation (Behavioral)
结局指标
主要结局
Piper Fatigue Scale
时间窗: This will be assessed on day 1 (baseline), day 2 and day 3 (post-testing), both before and after randomized activities.
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.
次要结局
- Perceived Mental Fatigue(The PMFQ will be assessed on day 1 (baseline), day 2, and day 3 (post-testing).)
- Energy subscale of AD ACL-SAI(This will be assessed following randomized activities on Day 1 (baseline), Day 2, and Day 3 (post-testing).)
- Tiredness subscale of AD ACL-SAI(This will be assessed following randomized activities on Day 1 (baseline), Day 2, and Day 3 (post-testing).)
- Attention- Assessed by Flanker Inhibitory Control and Attention task from the NIH toolbox(This will be assessed prior to randomized activities on day 1 (baseline), and day 3 (post-testing))
- Working Memory- Assessed by Picture Sequence task from the NIH toolbox(This will be assessed prior to randomized activities on day 1 (baseline), and day 3 (post-testing))
- Cognitive Flexibility and Attention- Assessed by Dimensional Change Card Sort Task from the NIH toolbox(This will be assessed prior to randomized activities on day 1 (baseline), and day 3 (post-testing))
- Program Evaluation - Perceived Usefulness(This will be assessed on day 3.)
- Program Evaluation - Perceived Ease of Use(This will be assessed on day 3.)
- Program Evaluation - Enjoyment(This will be assessed on day 3.)
- Program Evaluation - Satisfaction(This will be assessed on day 3.)
- Program Evaluation - Open Ended(This will be assessed on day 3.- focusing on thoughts of the program over the three appointment days, in a 1-week period.)
研究者
Sean Mullen
Associate Professor
University of Illinois at Urbana-Champaign