Study of the Effects of Implementing Dietary-nutritional Strategies and an Exercise Program at the Physical, Physiological, and Psychological Level in Women With a History of Breast Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in Fat-Free Mass (kg)
研究概览
简要总结
This study aims to evaluate the effects of a combined dietary-nutritional and physical exercise intervention on physical, physiological, and psychological outcomes in women who are breast cancer survivors. Participants will be randomly assigned to different intervention groups involving dietary modification, exercise training, or their combination, compared to a control group. The program will last 12 weeks and will include pre- and post-intervention assessments of body composition, metabolic parameters, functional capacity, and quality of life.
The primary goal is to assess improvements in physical fitness, body composition, and emotional well-being, as well as to identify potential synergistic effects of combined interventions in this population.
详细描述
Breast cancer survivors often experience long-term physical and psychological side effects derived from treatment, such as fatigue, loss of muscle mass, metabolic alterations, and reduced quality of life. Lifestyle interventions involving nutrition and exercise have demonstrated significant potential to mitigate these effects and promote overall recovery.
This randomized controlled clinical trial will include adult female breast cancer survivors who have completed their primary oncological treatment. Participants will be divided into six parallel groups:
- Control group - no intervention.
- Mediterranean diet group (MD) - individualized nutritional plan based on Mediterranean dietary patterns.
- Strength training group (ST) - supervised resistance exercise sessions.
- Endurance training group (ET) - supervised aerobic exercise sessions.
- Combined training group (CT) - combination of strength and endurance training.
- Combined diet and exercise group (MD+CT) - simultaneous application of Mediterranean diet and combined training.
The intervention will last 12 weeks, during which participants in the intervention groups will attend supervised sessions and receive continuous nutritional guidance. Assessments will be performed at baseline and after 12 weeks, including anthropometric and body composition analysis, metabolic and inflammatory markers, physical fitness testing, dietary intake, and psychological well-being scales.
This study seeks to identify the most effective strategy-dietary, physical, or combined-for improving health outcomes, functionality, and emotional recovery in breast cancer survivors, contributing to the development of comprehensive post-treatment rehabilitation programs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 30 to 65 years.
- •Previous diagnosis of breast cancer (stages I-III) confirmed by medical records.
- •Completion of primary oncological treatment (surgery, radiotherapy, chemotherapy, and/or hormone therapy) at least 3 months before enrollment.
- •Absence of active cancer or evidence of recurrence.
- •Medical clearance to perform physical exercise.
- •Willingness to participate in dietary and/or exercise interventions for 12 weeks.
- •Ability to attend evaluation and intervention sessions and comply with study procedures.
- •Signed written informed consent.
排除标准
- •Active cancer, metastasis, or ongoing chemotherapy or radiotherapy.
- •Severe cardiovascular, respiratory, renal, hepatic, or metabolic disease that contraindicates exercise.
- •Musculoskeletal or neurological conditions limiting participation in physical activity.
- •Severe psychiatric disorders or cognitive impairment affecting adherence to the intervention.
- •Current participation in another clinical trial or structured lifestyle intervention.
- •Use of dietary supplements, appetite regulators, or pharmacological agents affecting metabolism during the study period.
- •Pregnancy, breastfeeding, or intention to become pregnant during the study.
- •Inability to comply with the intervention schedule or follow-up assessments.
研究组 & 干预措施
Arm 5 - Combined Training Group (CT)
Participants will perform both strength and aerobic training during the 12-week intervention. Each session (3 per week, 60-70 minutes) will include resistance exercises targeting major muscle groups followed by aerobic activity at moderate intensity. The program aims to improve both muscular and cardiovascular performance synergistically.
干预措施: Combined Strength and Endurance Training Program (Behavioral)
Arm 6 - Mediterranean Diet plus Combined Training Group (MD+CT)
Participants will simultaneously receive the Mediterranean Diet counseling and participate in the Combined Training program for 12 weeks. The objective is to assess the synergistic effects of diet and exercise on physical, physiological, and psychological health in breast cancer survivors.
干预措施: Combined Mediterranean Diet and Exercise Program (Behavioral)
Arm 1 - Control Group
Participants will not receive any specific dietary or exercise intervention. They will be asked to maintain their usual lifestyle and dietary habits during the 12-week study period. General health recommendations based on national guidelines will be provided at baseline.
Arm 2 - Mediterranean Diet Group (MD)
Participants will receive individualized nutritional counseling promoting adherence to a Mediterranean dietary pattern, emphasizing fruits, vegetables, legumes, whole grains, olive oil, nuts, fish, and moderate dairy intake. Processed and high-sugar foods will be limited. Dietitians will provide personalized follow-up and adjustments every two weeks to ensure adherence.
干预措施: Mediterranean Diet Counseling (Behavioral)
Arm 3 - Strength Training Group (ST)
Participants will perform a 12-week supervised resistance training program focused on improving muscular strength and functional capacity. Sessions will be conducted three times per week, lasting approximately 60 minutes, and include major muscle groups using elastic bands, free weights, and bodyweight exercises. Training load will progressively increase according to individual capacity.
干预措施: Supervised Strength Training Program (Behavioral)
Arm 4 - Endurance Training Group (ET)
Participants will follow a structured aerobic exercise program consisting of walking, cycling, or treadmill sessions three times per week for 12 weeks. The intensity will be moderate (60-75% of estimated maximal heart rate), gradually progressing as tolerated. The goal is to enhance cardiorespiratory fitness and overall endurance.
干预措施: Supervised Endurance Training Program (Behavioral)
结局指标
主要结局
Change in Fat-Free Mass (kg)
时间窗: Baseline and Week 12
To evaluate changes in fat-free mass after the 12-week intervention, measured by bioimpedance analysis (BIODY XPERT ZM).
次要结局
- Change in Body Weight (kg)(Baseline and Week 12)
- Change in Fat Mass (%)(Baseline and Week 12)
- Change in Waist Circumference (cm)(Baseline and Week 12)
- Change in Handgrip Strength (kg)(Baseline and Week 12)
- Change in Lower-Limb Strength (kg)(Baseline and Week 12)
- Change in Flexibility (Sit-and-Reach Test, cm)(Baseline and Week 12)
- Change in Maximal Oxygen Uptake (VO₂max, mL/kg/min)(Baseline and Week 12)
- Change in Body Mass Index (kg/m²)(Baseline and Week 12)
- Change in Functional Capacity (6-Minute Walk Test Distance, m)(Baseline and Week 12)
- Change in Balance Performance(Baseline and Week 12)
- Change in Total Cholesterol (mg/dL)(Baseline and Week 12)
- Change in HDL Cholesterol (mg/dL)(Baseline and Week 12)
- Change in LDL Cholesterol (mg/dL)(Baseline and Week 12)
- Change in Triglycerides (mg/dL)(Baseline and Week 12)
- Change in Fasting Glucose (mg/dL)(Baseline and Week 12)
- Change in C-Reactive Protein (mg/L)(Baseline and Week 12)
- Change in Interleukin-6 (pg/mL)(Baseline and Week 12)
- Change in Fatigue (FACIT-F Questionnaire Score)(Baseline and Week 12)
- Change in Sleep Quality (PSQI Total Score)(Baseline and Week 12)
- Change in Physical Activity Level (IPAQ Total Score)(Baseline and Week 12)
- Change in Dietary Adherence (Mediterranean Diet Adherence Screener Score)(Baseline and Week 12)
研究者
Prof. Dr. Alejandro Martínez-Rodríguez
Full Professor of Health Sciences
University of Alicante