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

Cognitive Impairment Clinical Trial

— BRAINonFIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06073717
• Other study ID #: 0570-N-23
• Status: Recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: December 2025

Study information

• Verified date: June 2024
• Source: University of Seville
• Contact: Jesus Orellana
• Phone: 691436904
• Email: orellanajaenjesus1995[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: December 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer Survivors
• Breast Neoplasms
• Cognitive Dysfunction
• Cognitive Impairment
• Executive Dysfunction

Intervention

Behavioral:
• Exercise
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
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
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.

Locations

Country	Name	City	State
Spain	Laboratorio de Ciencias del Deporte	Sevilla
Spain	Oncoavanze	Sevilla
Spain	SADUS - Servicio de Actividades Deportivas de la Universidad de Sevilla	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
University of Seville

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Inhibitory Control and Concentration	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)	Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Secondary	Verbal Intelligence, Non-verbal Intelligence, Verbal memory, and Non-verbal Memory	Reynolds Intellectual Assessment Scale (Global index values range from = 69 to = 130, mean value of 100; higher scores mean better results)	Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Secondary	Learning Ability	Wechsler Memory Scale subtest "word pairs" (The subtest score range from 40 to 60, mean value of 100; higher scores mean better results)	Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Secondary	Perceived Cognitive Functions	Functional Assessment of Cancer Therapy: Cognition (FACT-Cog) (Total score ranges from 0 to 148; higher scores mean better results)	Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Secondary	Max. Oxygen Consumption	Modified Bruce Test (80% sub-max)	Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Secondary	Muscular Strength of shoulder and knee extensors	Isokinetic dynamometer	Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Secondary	Range of Movement	Manual Goniometer	Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Secondary	Forced Vital Capacity (FVC) and Forced Expiratory Volume (FEV)	Spirometry (FEV/FVC ratio, represented in percentages)	Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Secondary	Volume of physical activity	Accelerometer (Volume in minutes per week)	Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Secondary	Intensity of Physical Activity	Accelerometer (Intensity in metabolic equivalents)	Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Secondary	Weight and Height	Body Mass Index (weight and height will be combined to report BMI in kg/m^2)	Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Secondary	Brain-Derived Neurotrophic Factor (BDNF), Vascular Endothelial Growth Factor (VEGF), Fibroblast Growth Factor 17 (FDF-17), Soluble Klotho (S-KL)	Concentration of these proteins in plasma by ELISA kit (Concentration of these proteins will be expressed in pg/mL or ng/mL)	Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Secondary	Fatigue	Functional Assessment of Chronic Illness Therapy: Fatigue (FACIT-F) (Total score range from 0 to 52; higher scores mean better results)	Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Secondary	Pain Scale	Visual Analogue Scale (Total score ranges from 0 to 10; higher scores mean worse results)	Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Secondary	Depression	Back Depression Inventory (Total score ranges from 0 to 63; higher scores mean worse results)	Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)
Secondary	Anxiety	State-Trait Anxiety Inventory (The score ranges from 20 to 80; higher scores mean worse results)	Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline)