Breast Cancer, Sarcopenia
Conditions
Brief summary
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.
Interventions
BEHAVIORAL"Exercise for Muscle Health" Program
Participants receive routine rehabilitation care for breast cancer survivors, including: (1) provision of a breast cancer rehabilitation knowledge booklet covering lymphedema prevention, balanced diet, and weight management; (2) general physical activity advice recommending at least 150 minutes of moderate-intensity aerobic exercise (such as walking) per week, without structured exercise prescriptions, standardized instruction, intensity monitoring, or regular supervision.
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Single Blind（Outcomes Assessor）
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Appendicular Skeletal Muscle Mass Index (ASMI) | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sarcopenia Disease Knowledge | Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3) | Measured using the Sarcopenia Disease Knowledge Scale developed by Tang et al. (2023), a self-reported 18-item scale covering etiology, clinical manifestations, hazards, diagnosis, and treatment. Likert 5-point scoring, higher scores indicate better knowledge. |
| Cancer Self-Efficacy | Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3) | Measured using the Chinese version of the Strategies Used by People to Promote Health (SUPPH), a 28-item self-reported scale. Higher scores indicate greater self-efficacy in cancer self-management. |
| Social Support | Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3) | Measured using the Social Support Rating Scale (SSRS) developed by Xiao Shuiyuan, a 10-item scale with three dimensions: objective support, subjective support, and utilization of support. Total score ranges from 12 to 66, with higher scores indicating higher social support. |
| Anxiety | Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3) | Measured using the Generalized Anxiety Disorder-7 (GAD-7) scale, a 7-item self-reported scale. Total score ranges from 0 to 21, with higher scores indicating more severe anxiety. |
| Cancer-Related Fatigue | Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3) | Measured using the Cancer Fatigue Scale (CFS), a 15-item scale with three dimensions: physical fatigue (7 items), affective fatigue (4 items), and cognitive fatigue (4 items). Likert 4-point scoring, total score ranges from 0 to 60 |
| Change in Quality of Life | Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3) | Measured using the 36-item Short-Form Health Survey (SF-36), Chinese version. Eight dimensions: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each dimension scored 0-100, with higher scores indicating better health status. |
Countries
China
Contacts
CONTACTJun-E Liu, Prof.
Outcome results
None listed