Randomized Controlled Trial of a Combined Exercise Training Program on Physical Function and Quality of Life in Women With Metastatic Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Cardiorespiratory endurance and functional capacity
研究概览
简要总结
The primary objective of the study is to evaluate the effects of exercise on physical function, physical fitness, and body composition, with the main components including muscular strength, cardiorespiratory fitness, muscle mass, fat mass, and fat-free mass. The secondary objectives are to examine exercise adherence and the effects of exercise on health-related quality of life (HRQoL), cancer-related fatigue, and sleep quality. Additionally, the feasibility and safety of the exercise program will be assessed.
详细描述
Historically, cancer patients, especially those in more advanced stages of the disease, were advised to maintain rest due to concerns about complications associated with tumor progression and the adverse effects of treatment. However, evidence accumulated over the past decades has demonstrated that physical inactivity may accelerate functional decline, reduce physical capacity, and impair quality of life in individuals with cancer. In this context, physical exercise has come to be recognized as an important strategy in cancer care. The regular practice of aerobic and resistance exercises has been associated with the reduction of treatment-related side effects, the preservation of physical function, and improvements in quality of life in different populations of cancer patients. In women with breast cancer, studies have shown that physical exercise can contribute to improvements in cardiorespiratory capacity, muscular strength, physical function, and quality of life, as well as help reduce cancer-related fatigue. However, most of the available evidence focuses on patients in the early stages of the disease or after primary treatment. In the case of women with metastatic breast cancer, scientific knowledge remains limited. Despite therapeutic advances that have increased survival in this population, these patients frequently experience functional decline, severe fatigue, loss of muscle mass and strength, and reduced quality of life. Furthermore, physical exercise is still rarely incorporated into the care of these patients, often due to uncertainties regarding the safety and effectiveness of such interventions. Although emerging evidence suggests that physical exercise may be safe and feasible for patients with metastatic disease, studies investigating structured and long-term exercise interventions in this population remain scarce. Therefore, further research is necessary to expand understanding of the effects of physical exercise in women with metastatic breast cancer, particularly focusing on physical function, physical fitness, body composition, and quality of life.
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)
盲法说明
Participants and investigators were not blinded to group assignment, given the nature of the intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged ≥ 18 years;
- •Confirmed diagnosis of stage IV (metastatic) breast cancer;
- •Currently undergoing medical treatment;
- •Willingness and functional independence to participate in the exercise program;
- •Medical clearance to engage in structured physical exercise.
排除标准
- •Presence of unstable bone metastases.
- •Untreated or symptomatic brain metastases;
- •Evidence of severe cardiovascular disease identified by electrocardiogram (ECG);
- •Severe active infection;
- •Uncontrolled severe respiratory insufficiency or dependence on supplemental oxygen at rest or during exercise;
- •Uncontrolled severe pain;
- •Any other medical condition contraindicating participation in physical exercise;
- •Conditions that impair adherence to study procedures or the ability to provide informed consent;
- •Pregnancy.
研究组 & 干预措施
Exercise group
The exercise group will be instructed to complete 48 supervised, multicomponent physical training sessions over a 24-week period, with a frequency of two sessions per week on non-consecutive days.
干预措施: Exercise (Other)
Control group
Participants in the waitlist control group received standard medical care, without any exercise program or specific exercise recommendations. To maintain contact with the investigators and minimize study dropout, the waitlist control group received general health information through monthly online meetings.
结局指标
主要结局
Cardiorespiratory endurance and functional capacity
时间窗: Baseline and week 24 (post exercise intervention)
6MWT was performed as a parameter of cardiorespiratory endurance and functional capacity. Participants were instructed to walk back and forth along a flat, straight 25m corridor for six minutes, covering as much distance as possible at a self-selected pace. The total distance walked (in meters) was recorded as the primary outcome.
Lower-limb muscle strength
时间窗: Baseline and week 24 (post exercise intervention)
Lower-limb muscle strength was assessed using the five-repetition sit-to-stand test (5xSTS), according to the European Working Group on Sarcopenia in Older People (EWGSOP2)¹. Participants were instructed to stand up and sit down five times as quickly as possible, with their arms crossed over the chest. The total time to complete the test was recorded in seconds (s) and used as an indicator of muscle strength. All assessments were performed by a trained evaluator
Handgrip strength
时间窗: Baseline and week 24 (post exercise intervention)
Muscle strength was assessed using a handgrip dynamometer (SH5001, Saehan Grip, South Korea). Participants performed three maximal voluntary contractions with each hand in an alternating sequence, with a one-minute rest interval between trials. The highest value (kg) achieved was used for analysis. All measurements wer
次要结局
- Body composition(Baseline and week 24 (post exercise intervention))
- Health-related quality of life(Baseline and week 24 (post exercise intervention))
- Fatigue(Baseline and week 24 (post exercise intervention))