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NCT07732101

Overview

NCT ID: NCT07732101
Lead Sponsor: Capital Medical UniversityOTHER
Official Title: Development and Evaluation of an Exercise Intervention Program for Breast Cancer Patients With Sarcopenia During Rehabilitation
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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 28, 2026Actual
Start Date: Sep 1, 2026Estimated
Primary Completion Date: Sep 20, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 104Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: Jun-E Liu, Prof.Contact
liujune66@ccmu.edu.cn+86 18500136128

Similar Studies

Participant Group/Arms

Exercise Intervention GroupExperimental

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 GroupNo 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.