Responsiveness to Acute Changes in Exercise and Relaxation (RACER) Trial
RACER
Acute Effects of Aerobic Exercise and Relaxation on Fatigue and Executive Function in Breast Cancer Survivors
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable breast-cancer
Started Oct 2018
Shorter than P25 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2018
CompletedFirst Posted
Study publicly available on registry
October 11, 2018
CompletedStudy Start
First participant enrolled
October 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2019
CompletedApril 16, 2019
April 1, 2019
5 months
October 3, 2018
April 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Piper Fatigue Scale
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.
Secondary Outcomes (11)
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)
- +6 more secondary outcomes
Study Arms (3)
Aerobic Exercise Only
ACTIVE COMPARATORParticipants 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.
Relaxation Only
ACTIVE COMPARATORParticipants 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.
Aerobic Exercise and Relaxation
EXPERIMENTALParticipants 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).
Interventions
This intervention will combine 20 minutes of moderate aerobic exercise followed by 20 minutes of mindfulness training.
This intervention will combine 20 minutes of moderate aerobic exercise followed by 20 minutes of quiet rest.
This intervention will combine 20 minutes of mindfulness-based relaxation training followed by 20 minutes of quiet rest.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801, United States
Related Publications (1)
Cohen J, Rogers WA, Petruzzello S, Trinh L, Mullen SP. Acute effects of aerobic exercise and relaxation training on fatigue in breast cancer survivors: A feasibility trial. Psychooncology. 2021 Feb;30(2):252-259. doi: 10.1002/pon.5561. Epub 2020 Oct 14.
PMID: 33010183DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sean P Mullen, PhD
University of Illinois at Urbana-Champaign
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 3, 2018
First Posted
October 11, 2018
Study Start
October 15, 2018
Primary Completion
February 28, 2019
Study Completion
February 28, 2019
Last Updated
April 16, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Although this is not an NIH funded study, we will update these records within 1 year of data collection completion per NIH guidelines.
- Access Criteria
- 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.
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.