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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
40
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Illinois
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Urbana、Illinois、アメリカ、61801
- University of Illinois at Urbana-Champaign
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～120年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
女性
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
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アクティブコンパレータ：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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アクティブコンパレータ：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Piper Fatigue Scale
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Perceived Mental Fatigue
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年10月15日
一次修了 (実際)
2019年2月28日
研究の完了 (実際)
2019年2月28日
試験登録日
最初に提出
2018年10月3日
QC基準を満たした最初の提出物
2018年10月8日
最初の投稿 (実際)
2018年10月11日
学習記録の更新
投稿された最後の更新 (実際)
2019年4月16日
QC基準を満たした最後の更新が送信されました
2019年4月15日
最終確認日
2019年4月1日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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 共有時間枠
Although this is not an NIH funded study, we will update these records within 1 year of data collection completion per NIH guidelines.
IPD 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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