Clinical trial · Interventional
Motor-cognitive Training Effects on Cognition in Breast Cancer Survivors: the BRAINonFIT Study (BRAINonFIT).
Motor-cognitive Training Effects on Cancer-related Cognitive Impairment and Muscle-brain Crosstalk Biomarkers in Breast Cancer Survivors: the BRAINonFIT Study
- 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 goal of this interventional study is to assess the effects of either physical exercise program or combined with cognitive training (dual motor and cognitive training program) on breast cancer survivors. The main questions it aims to answer are: * Analyze the effectiveness of a supervised dual-task training program or a physical exercise program on the executive functions of the participants. * Evaluate the impact of both interventions on physical function, emotional aspects, and important biomarkers related to muscle-brain crosstalk. Participants will perform a 20-week supervised and controlled program, three times a week, along with weekly calorie and step challenges. Researchers will compare the dual-task training group, with the physical exercise group, and with a control group, which will perform the guideline recommendations of physical activity (non-supervised) to see how these intervention approaches can impact cognitive functions, physical functions, emotional aspects, and biomarkers related to muscle-brain crosstalk. Assessments will take place at three-time points: at baseline, after the intervention (20 weeks post-baseline) and after a 12-week follow-up period (32 weeks post-baseline).
Conditions
Conditions (3)
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 Survivors | — | UNRESOLVED | — |
| Cognitive Impairment | — | UNRESOLVED | — |
| Executive Dysfunction | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exercise | Behavioral | — | UNRESOLVED |
| Health and Wellness | Behavioral | — | UNRESOLVED |
| Motor-cognitive Training | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Exercise Intervention
- description
- This arm will receive a 5-month (20 weeks) supervised exercise program based on aerobic and resistance/strength training together with a weekly calorie or step challenge.
- interventionNames
- Behavioral: Exercise
- type
- EXPERIMENTAL
- label
- Dual Motor-Cognitive Intervention
- description
- This arm will receive a 5-month (20 weeks) supervised and simultaneous dual-task program based on aerobic, resistance, and cognitive stimulation training together with a weekly calorie or step challenge
- interventionNames
- Behavioral: Motor-cognitive Training
- type
- ACTIVE_COMPARATOR
- label
- Health and Wellness Intervention
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with stage I-IIIA breast cancer * Completed primary treatment, including surgery, radiotherapy and/or chemotherapy * Scheduled to receive adjuvant endocrine therapy, or currently receiving adjuvant endocrine therapy * Without functional limitations or other illnesses that condition and prevent them from practising intense physical exercise * FACT-Cog questionnaire score ≥ 10th percentile considering age groups * Fluency in Spanish (spoken and written) Exclusion Criteria: * Undergoing radiotherapy and/or chemotherapy * FACT-Cog questionnaire score ≤ 10th percentile considering age groups * Congenital heart disease * Chronic lung disease * Severe psychiatric disorders * History of substance abuse, or dependence (other than tobacco) * Mood disorders require treatment (anxiety or depression) * Relapses (2-3 months before the study start)
References
Publications (2)
- BACKGROUNDJesus OJ, Luis CP, Matilde MF. Effects of exercise on cancer-related cognitive impairment in breast cancer survivors: a scoping review. Breast Cancer. 2023 Nov;30(6):885-909. doi: 10.1007/s12282-023-01484-z. Epub 2023 Jul 22. PMID 37480454
- DERIVEDOrellana-Jaen J, Mora-Fernandez M, Carrasco-Paez L. Effects of a motor and cognitive training program on executive function and different biomarkers related to muscle-brain crosstalk in breast cancer survivors: 3-arm randomised controlled BRAINonFIT study protocol. Contemp Clin Trials. 2024 Nov;146:107672. doi: 10.1016/j.cct.2024.107672. Epub 2024 Sep 10. PMID 39265784