이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Responsiveness to Acute Changes in Exercise and Relaxation (RACER) Trial (RACER)

2019년 4월 15일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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:

  1. 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.
  2. 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.
  3. 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.

연구 유형

중재적

등록 (실제)

40

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Illinois
      • Urbana, Illinois, 미국, 61801
        • University of Illinois at Urbana-Champaign

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

여성

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 삼루타

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: 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.
행동: Aerobic Exercise Only
This intervention will combine 20 minutes of moderate aerobic exercise followed by 20 minutes of quiet rest.
활성 비교기: 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.
행동: Relaxation Only
This intervention will combine 20 minutes of mindfulness-based relaxation training followed by 20 minutes of quiet rest.
실험적: 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).
행동: Aerobic Exercise and Relaxation
This intervention will combine 20 minutes of moderate aerobic exercise followed by 20 minutes of mindfulness training.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Piper Fatigue Scale
기간: 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.
This will be assessed on day 1 (baseline), day 2 and day 3 (post-testing), both before and after randomized activities.

2차 결과 측정

결과 측정
측정값 설명
기간
Perceived Mental Fatigue
기간: The PMFQ will be assessed on day 1 (baseline), day 2, and day 3 (post-testing).
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.
The PMFQ will be assessed on day 1 (baseline), day 2, and day 3 (post-testing).
Energy subscale of AD ACL-SAI
기간: This will be assessed following randomized activities on Day 1 (baseline), Day 2, and Day 3 (post-testing).
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.
This will be assessed following randomized activities on Day 1 (baseline), Day 2, and Day 3 (post-testing).
Tiredness subscale of AD ACL-SAI
기간: This will be assessed following randomized activities on Day 1 (baseline), Day 2, and Day 3 (post-testing).
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.
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
기간: This will be assessed prior to randomized activities on day 1 (baseline), and day 3 (post-testing)
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.
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
기간: This will be assessed prior to randomized activities on day 1 (baseline), and day 3 (post-testing)
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.
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
기간: This will be assessed prior to randomized activities on day 1 (baseline), and day 3 (post-testing)
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.
This will be assessed prior to randomized activities on day 1 (baseline), and day 3 (post-testing)
Program Evaluation - Perceived Usefulness
기간: This will be assessed on day 3.
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.
This will be assessed on day 3.
Program Evaluation - Perceived Ease of Use
기간: This will be assessed on day 3.
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.
This will be assessed on day 3.
Program Evaluation - Enjoyment
기간: This will be assessed on day 3.
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.
This will be assessed on day 3.
Program Evaluation - Satisfaction
기간: This will be assessed on day 3.
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.
This will be assessed on day 3.
Program Evaluation - Open Ended
기간: This will be assessed on day 3.- focusing on thoughts of the program over the three appointment days, in a 1-week period.
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.
This will be assessed on day 3.- focusing on thoughts of the program over the three appointment days, in a 1-week period.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Illinois at Urbana-Champaign

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2018년 10월 15일

기본 완료 (실제)

2019년 2월 28일

연구 완료 (실제)

2019년 2월 28일

연구 등록 날짜

최초 제출

2018년 10월 3일

QC 기준을 충족하는 최초 제출

2018년 10월 8일

처음 게시됨 (실제)

2018년 10월 11일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 4월 16일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 4월 15일

마지막으로 확인됨

2019년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 16381

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 기간

Although this is not an NIH funded study, we will update these records within 1 year of data collection completion per NIH guidelines.

IPD 공유 액세스 기준

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 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • ANALYTIC_CODE
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

유방암에 대한 임상 시험

Aerobic Exercise Only에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Guinea

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다