Clinical trial · Interventional
Responsiveness to Acute Changes in Exercise and Relaxation (RACER) Trial
Acute Effects of Aerobic Exercise and Relaxation on Fatigue and Executive Function in Breast Cancer Survivors
NCT03702712CI-TRIAL-00038160RACERcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aerobic Exercise and Relaxation | Behavioral | — | UNRESOLVED |
| Aerobic Exercise Only | Behavioral | — | UNRESOLVED |
| Relaxation Only | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Aerobic Exercise Only
- description
- 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.
- interventionNames
- Behavioral: Aerobic Exercise Only
- type
- ACTIVE_COMPARATOR
- label
- Relaxation Only
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDCohen 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 33010183