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

Not Applicable

Active, not recruiting

• Conditions: Cognitive Impairment; Executive Dysfunction; Breast Cancer Survivors
• Interventions: Behavioral: Motor-cognitive Training; Behavioral: Exercise; Behavioral: Health and Wellness

• Registration Number: NCT06073717
• Lead Sponsor: University of Seville

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-22
• Study First Submitted QC: 2023-10-02
• Study First Posted: 2023-10-10
• Study Start: 2024-10-01
• Status Verified: 2024-11
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Primary Completion: 2025-10
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 108

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dual Motor-Cognitive Intervention	Motor-cognitive Training	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
Exercise Intervention	Exercise	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.
Health and Wellness Intervention	Health and Wellness	This arm will receive a 5-month health and wellness program.

Primary Outcome Measures

Name	Time	Method
Executive Function (Cognitive Flexibility and Processing Speed)	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 Outcome Measures

Name	Time	Method
Learning Ability	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)
Perceived Cognitive Functions	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)
Volume of physical activity	Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)	Accelerometer (Volume in minutes per week)
Intensity of Physical Activity	Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)	Accelerometer (Intensity in metabolic equivalents)
Weight and Height	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)
Forced Vital Capacity (FVC) and Forced Expiratory Volume (FEV)	Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)	Spirometry (FEV/FVC ratio, represented in percentages)
Inhibitory Control and Concentration	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)
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)	Reynolds Intellectual Assessment Scale (Global index values range from ≤ 69 to ≥ 130, mean value of 100; higher scores mean better results)
Range of Movement	Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)	Manual Goniometer
Anxiety	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)
Muscular Strength of shoulder and knee extensors	Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)	Isokinetic dynamometer
Brain-Derived Neurotrophic Factor (BDNF), Vascular Endothelial Growth Factor (VEGF), Fibroblast Growth Factor 17 (FDF-17), Soluble Klotho (S-KL)	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)
Fatigue	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)
Pain Scale	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)
Depression	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)
Max. Oxygen Consumption	Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)	Modified Bruce Test (80% sub-max)

Trial Locations

Locations (3)

Laboratorio de Ciencias del Deporte; 🇪🇸 Sevilla, Spain

Oncoavanze; 🇪🇸 Sevilla, Spain

SADUS - Servicio de Actividades Deportivas de la Universidad de Sevilla; 🇪🇸 Sevilla, Spain