Effects of a Targeted Concurrent Training Program on the Exercise Adherence in Female Breast Cancer Survivors: a Randomized Controlled Trial
概览
- 阶段
- 不适用
- 干预措施
- concurrent
- 疾病 / 适应症
- Breast Cancer Stage I
- 发起方
- Universidad de Burgos
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Change in Quality of Life (Functional Assessment of Cancer Therapy-Breast [FACT-B] Total Score)
- 状态
- 已完成
- 最后更新
- 3个月前
概览
简要总结
Breast cancer (BC) is one of the most common cancers among women worldwide, with survival rates steadily improving due to advances in early detection and treatment. Despite these improvements, survivors frequently experience long-term side effects such as fatigue, reduced physical function, osteosarcopenia (loss of muscle mass and bone density), and diminished quality of life (QOL). These sequelae often lead to loss of independence, increased frailty, and reduced participation in daily activities. Physical activity, particularly structured and supervised programs, has been shown to mitigate many of these effects. Concurrent training, which combines strength, cardiovascular, and neuromotor exercise, provides a comprehensive approach that targets muscle mass, bone health, and functional mobility. However, adherence to regular physical activity in this population remains low, with most survivors not achieving recommended levels of at least 150 minutes per week of moderate-to-vigorous exercise. This pilot randomized controlled trial aims to evaluate the effects of a 6-week supervised concurrent training program in breast cancer survivors. The program includes 12 supervised sessions designed to improve exercise adherence, physical activity levels, and QOL. The intervention is compared with a control group that receives only a health education session. Outcomes include QOL assessed by the FACT-B questionnaire, physical activity levels measured by the GPAQ, sedentary time, functional fitness, anthropometry, and patient satisfaction. The study is expected to provide evidence that a short-term supervised concurrent training program can improve emotional well-being, preserve QOL, and increase adherence to physical activity in breast cancer survivors.
详细描述
This randomized, multicenter, parallel-controlled pilot trial was conducted in two tertiary hospitals in Spain to evaluate the effects of a short-term supervised concurrent training program on physical activity adherence and quality of life in breast cancer survivors. Participants allocated to the intervention group completed a 6-week supervised concurrent training program consisting of 12 sessions (two sessions per week, approximately 60 minutes per session). The training program combined resistance, cardiovascular, and neuromotor exercises and was designed to address muscle strength, cardiorespiratory fitness, coordination, and functional mobility. Exercise sessions were supervised by qualified exercise professionals trained in oncology rehabilitation. Exercise intensity was individually adjusted and monitored to ensure participant safety and adherence to the prescribed training load. The control group attended a single educational session focused on healthy lifestyle and nutrition and did not participate in the exercise program. Both groups continued to receive usual oncological follow-up throughout the study period. Assessments were conducted at baseline, immediately after the intervention (6 weeks), and during follow-up at 3 and 6 months to evaluate changes over time. Ethical approval was obtained from the institutional ethics committees of the participating centers (protocol code 2018/0009), and written informed consent was obtained from all participants prior to study participation.
研究者
入排标准
入选标准
- •Stage I-IIIA
- •Free of disease
- •Without active chemotherapeutic treatment
排除标准
- •Patients suffered from a chronic disease that prevented them from physical activity program
- •Patients with sequelae of surgery, edema of \>2 degrees in extremities with lymphadenectomy
- •Those women who performed PA according to the recommendations established by the WHO.
研究组 & 干预措施
Concurrent Training Program
This group will participate in a 6-week concurrent training program.
干预措施: concurrent
Health Education Only (Control)
This group will no participate in the concurrent training intervention program.
干预措施: Health Education Session
结局指标
主要结局
Change in Quality of Life (Functional Assessment of Cancer Therapy-Breast [FACT-B] Total Score)
时间窗: Baseline, post-intervention (6 weeks), 3 months, and 6 months.
Quality of life assessed using the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire. The FACT-B total score ranges from 0 to 148 points, with higher scores indicating better quality of life.
次要结局
- Change in Emotional Well-Being (Functional Assessment of Cancer Therapy-Breast Emotional Well-Being Subscale)(Baseline, post-intervention (6 weeks), 3 months, and 6 months.)
- Change in Physical Activity Level (MET-min/week, GPAQ)(Baseline, post-intervention (6 weeks), 3 months, and 6 months.)
- Mean Sedentary Time (minutes/day, GPAQ)(Baseline, post-intervention (6 weeks), 3 months, and 6 months.)
- Adherence to Exercise Program (percent of sessions attended)(During the 6-week intervention period.)
- Change in Weight (kg)(Baseline, post-intervention (6 weeks), 3 months, and 6 months)
- Change in Height (cm)(Baseline, post-intervention (6 weeks), 3 months, and 6 months.)
- Change in Body Mass Index (kg/m²)(Baseline, post-intervention (6 weeks), 3 months, and 6 months.)
- Change in Handgrip Strength (kg, dynamometer)(Baseline, post-intervention (6 weeks), 3 months, and 6 months.)
- Change in Cardiorespiratory Fitness (Harvard Step Test Fitness Index)(Baseline, post-intervention (6 weeks), 3 months, and 6 months.)
- Patient Satisfaction with the Intervention (Study-Specific Satisfaction Questionnaire)(Immediately post-intervention (6 weeks).)