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

University of Seville

Status: Active, not recruiting

Conditions: Cognitive Impairment; Breast Cancer Survivors; Executive Dysfunction

Treatments: Behavioral: Exercise; Behavioral: Motor-cognitive Training; Behavioral: Health and Wellness

Study type: Interventional

Funder types: Other

Identifiers

NCT06073717

0570-N-23

Details and patient eligibility

About

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).

Enrollment: 108 estimated patients

Sex: Female

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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108 participants in 3 patient groups

Exercise Intervention

Experimental group

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.

Treatment:

Behavioral: Exercise

Dual Motor-Cognitive Intervention

Experimental group

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

Treatment:

Behavioral: Motor-cognitive Training

Health and Wellness Intervention

Active Comparator group

Description:

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

Treatment:

Behavioral: Health and Wellness