SarcopeniaEX-BCSarcNCT07732101
Exercise Intervention for Breast Cancer Patients With Sarcopenia
A study testing "Exercise for Muscle Health" Program in people with Sarcopenia and Breast Cancer, run by Capital Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia, Breast Cancer
- What is being tested?
- "Exercise for Muscle Health" Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2026to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Fifth Medical Center of Chinese PLA General Hospital (South Campus)
Beijing, Beijing Municipality, 100054
Jun-E Liu, Doctor, +86 18500136128, liujune66@ccmu.edu.cn
About this study
Official title: Development and Evaluation of a Muscle Health Exercise Program On Sarcopenia In Breast Cancer Survivors During Rehabilitation
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.
Read more
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
- Being tested
- "Exercise for Muscle Health" Program
- Medical subject headings
- Sarcopenia, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Exercise for Muscle Health" ProgramBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)
Secondary outcomes (6)
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.
Measured: Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)
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.
Measured: Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)
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.
Measured: Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)
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.
Measured: Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)
Cancer-Related Fatigue
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
Measured: Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)
Change in Quality of Life
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.
Measured: Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start30 Oct 2026 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao-qin Su, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07732101
- Sponsor's protocol ID
- 2026SY708
- Acronym
- EX-BCSarc
- Status last verified
- Oct 2026
- First submitted
- 23 Jul 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with other researchers. This decision is based on the following considerations: (1) the informed consent form signed by participants does not include provisions for sharing individual-level data with external parties; (2) sharing of such data is restricted by China's Personal Information Protection Law to ensure strict protection of patient privacy; and (3) the study resources are insufficient to establish a secure public data repository for IPD.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of a Muscle Health Exercise Program On Sarcopenia In Breast Cancer Survivors During Rehabilitation
- ClinicalTrials.gov ID
- NCT07732101
- Acronym / sponsor ID
- EX-BCSarc / 2026SY708
- Conditions
- Sarcopenia, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention Group | Experimental | Behavioral: "Exercise for Muscle Health" ProgramA 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Exercise for Muscle Health" ProgramParticipants 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. | Behavioural | Exercise Intervention Group |
Primary outcome
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).
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.
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.
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.
6 secondary outcomes
Sarcopenia Disease Knowledge
Time frame: Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)
Cancer Self-Efficacy
Time frame: Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)
Social Support
Time frame: Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)
Anxiety
Time frame: Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)
Cancer-Related Fatigue
Time frame: Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)
Change in Quality of Life
Time frame: Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with other researchers. This decision is based on the following considerations: (1) the informed consent form signed by participants does not include provisions for sharing individual-level data with external parties; (2) sharing of such data is restricted by China's Personal Information Protection Law to ensure strict protection of patient privacy; and (3) the study resources are insufficient to establish a secure public data repository for IPD.
Related trials for Sarcopenia
Active, not recruitingObservational study
Possible Sarcopenia, Sarcopenia, and Functional Status in Patients With Primary Sjögren's Syndrome
Primary Sjögren Syndrome, Sarcopenia
Not yet recruiting
PROfiles of FGF-19 Post-prandial Secretion in Older Adults With Frailty and Without Frailty
Frailty, Sarcopenia
Recruiting
Resistance vs Aerobic Prehabilitation Before Colorectal Cancer Surgery
Colorectal Cancer, Colorectal Neoplasms
Recruiting
Effects of a Community-based Multicomponent Physical Exercise Program on Physical Function, Frailty, and Sarcopenia in Older Adults From the Municipality of Santoña: a Quasi-experimental Study.
Frailty/Sarcopenia, Frailty in Older Adults
Not yet recruiting
Creatine and Muscle Health in Madrid's Walking Footballers.
Muscle Adaptation, Body Composition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Exercise for Muscle Health" Program in people with Sarcopenia and Breast Cancer, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun-E Liu, Prof. (+86 18500136128, liujune66@ccmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.