Trial Title:
Motor-cognitive Training Effects on Cognition in Breast Cancer Survivors: the BRAINonFIT Study (BRAINonFIT).
NCT ID:
NCT06073717
Condition:
Breast Cancer Survivors
Cognitive Impairment
Executive Dysfunction
Conditions: Official terms:
Breast Neoplasms
Cognitive Dysfunction
Conditions: Keywords:
Cancer-related Cognitive Impairment
Physical exercise
dual motor-cognitive tasks
cognitive stimulation
Neurocognitive disorders
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This study has been designed as a randomised, controlled, longitudinal (20 weeks),
three-arm, parallel study with a follow-up phase (12 weeks).
Primary purpose:
Supportive Care
Masking:
Single (Participant)
Masking description:
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.
Intervention:
Intervention type:
Behavioral
Intervention name:
Exercise
Description:
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.
Arm group label:
Exercise Intervention
Intervention type:
Behavioral
Intervention name:
Motor-cognitive Training
Description:
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.
Arm group label:
Dual Motor-Cognitive Intervention
Intervention type:
Behavioral
Intervention name:
Health and Wellness
Description:
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.
Arm group label:
Health and Wellness Intervention
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).
Criteria for eligibility:
Criteria:
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)
Gender:
Female
Minimum age:
25 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
SADUS - Servicio de Actividades Deportivas de la Universidad de Sevilla
Address:
City:
Sevilla
Zip:
41012
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Jorge Tihriet
Phone:
95.448.77.00
Email:
sadus@us.es
Facility:
Name:
Laboratorio de Ciencias del Deporte
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Not yet recruiting
Contact:
Last name:
Alfonso J García González
Phone:
95.455.17.00
Email:
fce-informacion@us.es
Facility:
Name:
Oncoavanze
Address:
City:
Sevilla
Zip:
41013
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Lourdes Valero
Phone:
954 231 459
Email:
info@oncoavanze.es
Start date:
September 2024
Completion date:
December 2025
Lead sponsor:
Agency:
University of Seville
Agency class:
Other
Source:
University of Seville
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06073717
