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

NCT06073717 | Active Not Recruiting

• 1 other identifier: 0570-N-23
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 3

Brief Summary

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

Breast Cancer Survivors; Cognitive Impairment; Executive Dysfunction

Keywords

Cancer-related Cognitive Impairment; Physical exercise; dual motor-cognitive tasks; cognitive stimulation; Neurocognitive disorders

Outcome Measures

Primary Outcomes (1)

• Executive Function (Cognitive Flexibility and Processing Speed)

  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)

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

Secondary Outcomes (16)

• Inhibitory Control and Concentration

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

• Verbal Intelligence, Non-verbal Intelligence, Verbal memory, and Non-verbal Memory

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

• Learning Ability

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

• Perceived Cognitive Functions

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

• Max. Oxygen Consumption

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

Study Arms (3)

Exercise Intervention

EXPERIMENTAL

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.

Behavioral: Exercise

Dual Motor-Cognitive Intervention

EXPERIMENTAL

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

Behavioral: Motor-cognitive Training

Health and Wellness Intervention

ACTIVE COMPARATOR

This arm will receive a 5-month health and wellness program.

Behavioral: Health and Wellness

Interventions

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.

Exercise Intervention

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.

Dual Motor-Cognitive Intervention

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.

Health and Wellness Intervention

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Seville: lead

Study Sites (3)

SADUS - Servicio de Actividades Deportivas de la Universidad de Sevilla

Seville, Sevilla, 41012, Spain

Location

Laboratorio de Ciencias del Deporte

Seville, Sevilla, 41013, Spain

Location

Oncoavanze

Seville, Sevilla, 41013, Spain

Location

Related Publications (2)

• Jesus 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 BACKGROUND

• Orellana-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 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Motor Activity; Neurocognitive Disorders

Interventions

Exercise; Health

Condition Hierarchy (Ancestors)

Cognition Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Population Characteristics

Study Officials

• Matilde Mora Fernández, PhD

  University of Seville

  STUDY DIRECTOR

• Luis Carrasco Páez, PhD

  University of Seville

  STUDY DIRECTOR

• Jesús Orellana Jaén

  University of Seville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Regarding the control of experimental bias, simple blinding will be used. Thus, participants will be blinded to the research problem. They will be informed that three interventions will be applied (without comment on specific details of each one) randomly allocated, to compare the impact on cognitive functions, circulating levels of certain biomarkers, and different symptoms associated with breast cancer. Therefore, study participants will not be able to know to which experimental or control group they belong.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study has been designed as a randomised, controlled, longitudinal (20 weeks), three-arm, parallel study with a follow-up phase (12 weeks).

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: October 10, 2023
• Study Start: October 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)