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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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Intervention | Experimental | 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. |
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| Dual Motor-Cognitive Intervention | Experimental | 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 |
|
| Health and Wellness Intervention | Active Comparator | This arm will receive a 5-month health and wellness program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matilde Mora Fernández, PhD | University of Seville | Study Director |
| Luis Carrasco Páez, PhD | University of Seville | Study Director |
| Jesús Orellana Jaén | University of Seville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SADUS - Servicio de Actividades Deportivas de la Universidad de Sevilla | Seville | Sevilla | 41012 | Spain | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37480454 | Background | 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. | |
| 39265784 | Derived | Orellana-Jaen J, Mora-Fernandez M, Carrasco-Paez L. Effects of a motor and cognitive training program on executive function and different biomarkers related to muscle-brain crosstalk in breast cancer survivors: 3-arm randomised controlled BRAINonFIT study protocol. Contemp Clin Trials. 2024 Nov;146:107672. doi: 10.1016/j.cct.2024.107672. Epub 2024 Sep 10. |
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This study has been designed as a randomised, controlled, longitudinal (20 weeks), three-arm, parallel study with a follow-up phase (12 weeks).
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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.
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| Motor-cognitive Training | Behavioral | 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 | Behavioral | 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. |
|
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| Range of Movement | Manual Goniometer | Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| Laboratorio de Ciencias del Deporte |
| Seville |
| Sevilla |
| 41013 |
| Spain |
| Oncoavanze | Seville | Sevilla | 41013 | Spain |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D009043 | Motor Activity |
| D019965 | Neurocognitive Disorders |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D006262 | Health |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D011154 | Population Characteristics |
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