Evaluation of the Effects of Aerobic Exercise on Metabolic Biomarkers (NF-κB, Visfatin, and GDF15) and Quality of Life in Women With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Functional Capacity Assessed by the 6-Minute Walk Test
研究概览
简要总结
This study evaluates the effects of a 12-week supervised aerobic exercise program in women who have completed primary treatment for early-stage breast cancer and are in remission. The study aims to determine whether regular aerobic exercise is associated with changes in physical function, quality of life, cognitive function, and selected blood biomarkers.
Participants take part in a supervised aerobic exercise program for 12 weeks. Assessments are performed before the program, at week 6, and at week 12. These assessments include a walking test, questionnaires about quality of life and cognitive function, and blood sampling.
Blood samples are used to measure GDF15, NF-κB p105, and visfatin. Changes in these measures over the 12-week exercise period are evaluated together with changes in functional capacity and patient-reported outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-65 years. Histologically confirmed stage I-II nonmetastatic breast cancer. Completion of indicated primary cancer treatment at least 6 months before enrollment and currently in remission.
- •Ongoing endocrine therapy was permitted. No participation in regular structured physical activity during the preceding 6 months.
- •Medically eligible to participate in aerobic exercise and study assessments. Physician clearance to participate in aerobic exercise. Residing in or near the city where the study was conducted. Provision of written informed consent.
排除标准
- •Metastatic breast cancer. Clinically significant cardiovascular, respiratory, neurological, or musculoskeletal conditions that could limit safe participation in aerobic exercise.
- •Clinically significant lymphedema. Pregnancy or breastfeeding. Use within the preceding 8 weeks of antidepressants, anxiolytics, antipsychotics, chronic analgesics, or sedatives considered likely to influence cognitive assessments or biological outcomes.
研究组 & 干预措施
Supervised Aerobic Exercise
Participants assigned to this arm will complete a 12-week supervised aerobic exercise program. Assessments will be performed at baseline, week 6, and week 12.
干预措施: Supervised Aerobic Exercise Program (Behavioral)
结局指标
主要结局
Functional Capacity Assessed by the 6-Minute Walk Test
时间窗: Baseline, week 6, and week 12
Functional capacity will be assessed using the 6-minute walk test (6MWT). The total distance walked during 6 minutes will be recorded in meters, with greater distances indicating better functional capacity.
Serum Growth Differentiation Factor 15 (GDF15) Level
时间窗: Baseline, week 6, and week 12
Serum GDF15 concentrations will be measured using an enzyme-linked immunosorbent assay (ELISA) and reported in pg/mL. Changes in GDF15 levels during the supervised aerobic exercise program will be evaluated.
Serum Nuclear Factor Kappa B p105 (NF-κB p105) Level
时间窗: Baseline, week 6, and week 12
Serum NF-κB p105 concentrations will be measured using an enzyme-linked immunosorbent assay (ELISA) and reported in ng/mL. Changes in NF-κB p105 levels during the supervised aerobic exercise program will be evaluated.
Serum Visfatin Level
时间窗: Baseline, week 6, and week 12
Serum visfatin concentrations will be measured using an enzyme-linked immunosorbent assay (ELISA) and reported in ng/mL. Changes in visfatin levels during the supervised aerobic exercise program will be evaluated.
次要结局
- Perceived Cognitive Abilities Assessed by the FACT-Cog(Baseline, week 6, and week 12)
- Perceived Cognitive Impairments(Baseline, week 6, and week 12)
- Quality of Life Assessed by the EORTC QLQ-C30(Baseline, week 6, and week 12)