Development and Evaluation of an Exercise Intervention Program for Breast Cancer Patients With Sarcopenia During Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Change in Appendicular Skeletal Muscle Mass Index (ASMI)
研究概览
简要总结
Sarcopenia is a common yet underrecognized complication in breast cancer survivors during rehabilitation, characterized by loss of muscle mass, reduced muscle strength, and impaired physical function, which adversely affects quality of life and long-term outcomes. Exercise has been identified as a promising non-pharmacological intervention for sarcopenia; however, evidence-based exercise programs specifically tailored for breast cancer patients with sarcopenia remain limited.
This study aims to develop and evaluate a 12-week exercise intervention program ("Exercise for Muscle Health") for breast cancer patients with sarcopenia during rehabilitation. A randomized controlled trial will be conducted to assess the effectiveness of the intervention. A total of 104 eligible participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. The intervention group will receive a 12-week structured exercise program combined with health education, while the control group will receive routine rehabilitation care with general physical activity recommendations.
The primary outcomes include changes in appendicular skeletal muscle mass index (ASMI), handgrip strength, Short Physical Performance Battery (SPPB) score, and physical fitness (2-Minute Step Test and 30-second Chair-Stand Test). Secondary outcomes include sarcopenia-related knowledge, cancer self-efficacy, social support, anxiety, fatigue, and quality of life. Assessments will be conducted at baseline (T0), mid-intervention (week 6, T1), immediately post-intervention (week 12, T2), and 3 months post-intervention (T3).
The hypothesis is that the 12-week "Exercise for Muscle Health" program will significantly improve muscle mass, muscle strength, and physical function compared to routine care, and will be feasible, acceptable, and safe for breast cancer patients with sarcopenia during rehabilitation.
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
Single Blind（Outcomes Assessor）
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female, aged ≥18 years;
- •Pathologically confirmed diagnosis of breast cancer, having completed primary treatment (surgery, chemotherapy, radiotherapy, etc.) and currently in the rehabilitation phase (≥3 months after treatment completion);
- •Meet sarcopenia diagnostic criteria assessed by trained researchers: for women aged ≥65 years, ASMI < 0.57 and handgrip strength < 18 kg; for women aged <64 years, ASMI < 0.63 and handgrip strength < 20 kg;
- •Provide informed consent and voluntarily participate in the study;
- •Have basic communication and comprehension abilities.
排除标准
- •History of psychiatric disorders or consciousness impairment;
- •Presence of exercise contraindications including severe cardiac, hepatic, or renal insufficiency, bone metastases, or uncontrolled hypertension;
- •Major surgery or severe trauma within the past 3 months;
- •Involuntary weight loss >5% within the past 3 months, or presence of active progressive tumor burden (e.g., imaging evidence of significant metastasis or receiving palliative chemotherapy), suggesting tumor-driven cachexia;
- •Currently participating in other exercise intervention studies or having completed other exercise programs within the past 6 months;
- •Refusal of randomization.
结局指标
主要结局
Change in Appendicular Skeletal Muscle Mass Index (ASMI)
时间窗: Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)
Measured using InBody 120 body composition analyzer via bioelectrical impedance analysis (BIA). ASMI is calculated as appendicular skeletal muscle mass (kg) divided by BMI (kg/m²).
Handgrip Strength
时间窗: Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)
Measured using CAMRY electronic handgrip dynamometer (Model EH101). Participants stand with arms naturally, maximal grip strength is recorded twice for each hand, and the maximum value is used.
Short Physical Performance Battery (SPPB) Score
时间窗: Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)
SPPB assesses lower extremity function through three tests: balance test (side-by-side, semi-tandem, and tandem stands), 4-meter gait speed test, and 5-repetition chair-stand test. Total score ranges from 0 to 12, with higher scores indicating better physical function.
Physical Fitness
时间窗: Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)
Assessed by 2-Minute Step Test (2-MST) measuring cardiorespiratory endurance and 30-second Chair-Stand Test (CST) measuring lower limb muscle strength.
次要结局
- Sarcopenia Disease Knowledge(Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3))
- Cancer Self-Efficacy(Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3))
- Social Support(Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3))
- Anxiety(Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3))
- Cancer-Related Fatigue(Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3))
- Change in Quality of Life(Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3))
研究者
Xiao-qin Su
Principal Investigator of the Study
Capital Medical University