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NCT Number: NCT06073717

Motor-cognitive Training Effects on Cognition in Breast Cancer Survivors: the BRAINonFIT Study (BRAINonFIT).

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Survivors Behavior Cognition Disorders Cognitive Dysfunction Cognitive Impairment Executive Dysfunction Mental Disorders Motor Activity Neurocognitive Disorders

Age range

25 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Laboratorio de Ciencias del Deporte, Seville, Sevilla, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exercise

Behavioral

Participants will complete a 5-month exercise program structured in 4 blocks of 5 weeks. Three supervised and combined aerobic/strength exercise sessions each week will be performed together with an aerobic weekly challenge. Aerobic exercise will be performed for 20-30 minutes using a treadmill, bicycle, or circuit training at light to moderate intensities (40-75% of heart rate reserve) during the first two blocks; gradually achieving high intensity (>75% of HHR) in the last two blocks. Heart rate and the subjective perception of the exertion scale (6-20 Borg scale) will be monitored. Strength exercises will be started at light to moderate intensities (2 sets of 15-20 repetitions at 40-50% of repetition maximum), performed muscle actions at high intensities in the last two blocks (2 sets of 8-15 repetitions at 50-75% RM); using elastic bands, free weights, and weights gym exercises.

Motor-cognitive Training

Behavioral

Participants will complete the same four-block exercise program in terms of type, frequency, intensity, and volume of physical/motor training. Simultaneous with the progression of physical/motor training, the complexity of cognitive stimulation will be increased according to the performance of the participants. General dual-task training will be performed, which describes the use of a physical/motor intervention with different cognitive stimulations (memory, language, intelligence, attention, processing speed, calculation, inhibitory control) that are not specific to the methods to be used for their assessment.

Health and Wellness

Behavioral

Participants randomly assigned to the health and wellness group will be advised and re-educated to support and improve health aspects. Participants in this group will aim to achieve the physical activity recommendations, and in addition, they will receive bi-weekly emails and phone call coaching with tools to empower patients with knowledge about physical exercise, nutrition, and brain health guidelines. Following completion of the 5-month exercise program, this group will receive an exercise program for 12 weeks.

Primary outcomes

  1. Executive Function (Cognitive Flexibility and Processing Speed)

    Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)

    Trail Making Test A and B (minimum and maximum values, defined by the time in seconds, depend on the age- and education-normalised groups; higher scores mean worse results)

Secondary outcomes

  1. Inhibitory Control and Concentration

    Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)

    Stroop Color and Word test (minimum and maximum values, defined by the time in seconds, depend on the age- and education-normalised groups; higher scores mean worse results)

  2. Verbal Intelligence, Non-verbal Intelligence, Verbal memory, and Non-verbal Memory

    Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)

    Reynolds Intellectual Assessment Scale (Global index values range from ≤ 69 to ≥ 130, mean value of 100; higher scores mean better results)

  3. Learning Ability

    Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)

    Wechsler Memory Scale subtest "word pairs" (The subtest score range from 40 to 60, mean value of 100; higher scores mean better results)

  4. Perceived Cognitive Functions

    Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)

    Functional Assessment of Cancer Therapy: Cognition (FACT-Cog) (Total score ranges from 0 to 148; higher scores mean better results)

  5. Max. Oxygen Consumption

    Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)

    Modified Bruce Test (80% sub-max)

  6. Muscular Strength of shoulder and knee extensors

    Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)

    Isokinetic dynamometer

  7. Range of Movement

    Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)

    Manual Goniometer

  8. Forced Vital Capacity (FVC) and Forced Expiratory Volume (FEV)

    Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)

    Spirometry (FEV/FVC ratio, represented in percentages)

  9. Volume of physical activity

    Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)

    Accelerometer (Volume in minutes per week)

  10. Intensity of Physical Activity

    Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)

    Accelerometer (Intensity in metabolic equivalents)

  11. Weight and Height

    Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)

    Body Mass Index (weight and height will be combined to report BMI in kg/m^2)

  12. Brain-Derived Neurotrophic Factor (BDNF), Vascular Endothelial Growth Factor (VEGF), Fibroblast Growth Factor 17 (FDF-17), Soluble Klotho (S-KL)

    Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)

    Concentration of these proteins in plasma by ELISA kit (Concentration of these proteins will be expressed in pg/mL or ng/mL)

  13. Fatigue

    Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)

    Functional Assessment of Chronic Illness Therapy: Fatigue (FACIT-F) (Total score range from 0 to 52; higher scores mean better results)

  14. Pain Scale

    Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)

    Visual Analogue Scale (Total score ranges from 0 to 10; higher scores mean worse results)

  15. Depression

    Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)

    Back Depression Inventory (Total score ranges from 0 to 63; higher scores mean worse results)

  16. Anxiety

    Time frame: Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)

    State-Trait Anxiety Inventory (The score ranges from 20 to 80; higher scores mean worse results)

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Registry information

Official study title

Motor-cognitive Training Effects on Cancer-related Cognitive Impairment and Muscle-brain Crosstalk Biomarkers in Breast Cancer Survivors: the BRAINonFIT Study

Acronym: BRAINonFIT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 10, 2023
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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