Motor-cognitive Training Effects on Cancer-related Cognitive Impairment and Muscle-brain Crosstalk Biomarkers in Breast Cancer Survivors: the BRAINonFIT Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 108
- 试验地点
- 6
- 主要终点
- Executive Function (Cognitive Flexibility and Processing Speed)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
Exercise Intervention
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.
干预措施: Exercise (Behavioral)
Dual Motor-Cognitive Intervention
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
干预措施: Motor-cognitive Training (Behavioral)
Health and Wellness Intervention
This arm will receive a 5-month health and wellness program.
干预措施: Health and Wellness (Behavioral)
结局指标
主要结局
Executive Function (Cognitive Flexibility and Processing Speed)
时间窗: 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)
次要结局
- Learning Ability(Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline))
- Perceived Cognitive Functions(Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline))
- Volume of physical activity(Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline))
- Intensity of Physical Activity(Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline))
- Weight and Height(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)(Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline))
- Inhibitory Control and Concentration(Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline))
- 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))
- Range of Movement(Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline))
- Anxiety(Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline))
- Muscular Strength of shoulder and knee extensors(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)(Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline))
- Fatigue(Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline))
- Pain Scale(Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline))
- Depression(Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline))
- Max. Oxygen Consumption(Baseline (week 0); Post-intervention (25 weeks post-baseline); and Post-follow up (32 weeks post-baseline))
研究者
Jesus Orellana Jaen
Principal Investigator
University of Seville