Exercise Intervention for Breast Cancer Patients With Sarcopenia

Sponsor
Capital Medical University
Study ID
NCT07732101
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • "Exercise for Muscle Health" Program — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
Jul 28, 2026
Start date
Sep 1, 2026
Status verified
Jul 2026
Primary completion
Sep 20, 2026
Completion
Apr 20, 2027

Study Design

Enrollment
104 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Exercise Intervention Group
    A 12-week structured exercise intervention program consisting of two components: (1) Health education ; (2) Exercise intervention. The intervention is delivered by trained exercise specialists and supervised by the research team. Participants receive exercise diaries to record adherence.
  • No Intervention: Control Group
    Participants receive routine rehabilitation care for breast cancer survivors, including: (1) Health education: provision of a breast cancer rehabilitation knowledge booklet covering lymphedema prevention, balanced diet, and weight management; (2) General physical activity advice: recommendation to engage in at least 150 minutes of moderate-intensity aerobic exercise (such as walking) per week, without provision of structured exercise prescriptions, standardized exercise instruction, intensity monitoring, or regular supervision.

Primary Outcome Measure

Change in Appendicular Skeletal Muscle Mass Index (ASMI) [ Time Frame: Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3) ]

Central Contacts

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