Exercise Intervention for Breast Cancer Patients With Sarcopenia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCapital Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
"Exercise for Muscle Health" Program
BehavioralParticipants 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.
Treatment groups
104 Participants
are divided into 2 treatment groupsGroup A: Exercise Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in Appendicular Skeletal Muscle Mass Index (ASMI)
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).
Time frame
Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)2
Handgrip Strength
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.
Time frame
Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)3
Short Physical Performance Battery (SPPB) Score
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.
Time frame
Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)4
Physical Fitness
Assessed by 2-Minute Step Test (2-MST) measuring cardiorespiratory endurance and 30-second Chair-Stand Test (CST) measuring lower limb muscle strength.
Time frame
Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)Secondary outcomes
1
Sarcopenia Disease Knowledge
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.
Time frame
Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)2
Cancer Self-Efficacy
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.
Time frame
Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)3
Social Support
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.
Time frame
Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)4
Anxiety
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.
Time frame
Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)Sponsors and contacts
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Source ClinicalTrials.gov
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