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Life sciences · Interventional Study
ClinicalTrials.gov · November 2, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07732101). This is a study registration, not published results. Lead sponsor: Capital Medical University. Recruitment status: ENROLLING_BY_INVITATION. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 104 participants (ESTIMATED). Conditions: Sarcopenia, Breast Cancer. Interventions: BEHAVIORAL: "Exercise for Muscle Health" Program. Primary outcome measures: Change in Appendicular Skeletal Muscle Mass Index (ASMI) , Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3); Handgrip Strength , Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3); Short Physical Performance Battery (SPPB) Score , Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3); Physical Fitness , Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3). 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.