Breast Cancer Survivors, Cognitive Impairment, Executive Dysfunction
Conditions
Keywords
Cancer-related Cognitive Impairment, Physical exercise, dual motor-cognitive tasks, cognitive stimulation, Neurocognitive disorders
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).
Interventions
BEHAVIORALExercise
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.
BEHAVIORALMotor-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.
BEHAVIORALHealth 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.
Sponsors
University of Seville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
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 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).
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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) |
| 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 |
| Range of Movement | Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline) | Manual Goniometer |
| 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) |
| 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) |
| 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) |
| 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) |
Countries
Spain
Contacts
STUDY_DIRECTORMatilde Mora Fernández, PhD
University of Seville
STUDY_DIRECTORLuis Carrasco Páez, PhD
University of Seville
PRINCIPAL_INVESTIGATORJesús Orellana Jaén
University of Seville
Outcome results
None listed