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NCT Number: NCT07732101

Exercise Intervention for Breast Cancer Patients With Sarcopenia

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.

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Key information

Conditions

Sarcopenia Atrophy Breast Cancer Breast Diseases Breast Neoplasms Muscular Atrophy Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Fifth Medical Center of Chinese PLA General Hospital (South Campus)

Beijing, Beijing Municipality, 100054, China

Location contact

Jun-E Liu, Doctor

CONTACT

[email protected]

+86 18500136128

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

"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.

Primary outcomes

  1. Change in Appendicular Skeletal Muscle Mass Index (ASMI)

    Time frame: 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).

  2. Handgrip Strength

    Time frame: 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.

  3. Short Physical Performance Battery (SPPB) Score

    Time frame: 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.

  4. Physical Fitness

    Time frame: 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 outcomes

  1. Sarcopenia Disease Knowledge

    Time frame: 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.

  2. Cancer Self-Efficacy

    Time frame: 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.

  3. Social Support

    Time frame: 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.

  4. Anxiety

    Time frame: 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.

  5. Cancer-Related Fatigue

    Time frame: 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

  6. Change in Quality of Life

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jun-E Liu, Prof.

CONTACT

[email protected]

+86 18500136128

Sponsors and collaborators

Lead sponsor

Capital Medical University

Other

Registry information

Official study title

Development and Evaluation of an Exercise Intervention Program for Breast Cancer Patients With Sarcopenia During Rehabilitation

Acronym: EX-BCSarc

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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