Exercise Intervention for Breast Cancer Patients With Sarcopenia

NCT07732101 | Not Yet Recruiting

• 1 other identifier: 2026SY708
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Breast Cancer

Outcome Measures

Primary Outcomes (4)

• 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).

  Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)

• 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.

  Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)

• 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.

  Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)

• 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.

  Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)

Secondary Outcomes (6)

• Sarcopenia Disease Knowledge

  Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)

• Cancer Self-Efficacy

  Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)

• Social Support

  Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)

• Anxiety

  Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)

• Cancer-Related Fatigue

  Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)

Study Arms (2)

Exercise Intervention Group

EXPERIMENTAL

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.

Behavioral: "Exercise for Muscle Health" Program

Control Group

NO INTERVENTION

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.

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.

Exercise Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100054, China

Location

MeSH Terms

Conditions

Sarcopenia; Breast Neoplasms

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Jun-E Liu, Prof.

CONTACT

+86 18500136128; liujune66@ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single Blind（Outcomes Assessor）
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of the Study

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 20, 2026
• Study Completion (Estimated): April 20, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)