Набор скоро начнётся NCT07732101

Exercise Intervention for Breast Cancer Patients With Sarcopenia

Без фазы С лечением Sarcopenia Breast Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: "Exercise for Muscle Health" Program.
Кому может быть актуально: Состояния в реестре: Sarcopenia, Breast Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Китай
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Вмешательства

Поведенческое "Exercise for Muscle Health" Program
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.

Первичные конечные точки

Change in Appendicular Skeletal Muscle Mass Index (ASMI) [Срок оценки: Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)]
Handgrip Strength [Срок оценки: Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)]
Short Physical Performance Battery (SPPB) Score [Срок оценки: Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)]
Physical Fitness [Срок оценки: Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)]

Вторичные конечные точки (6)

Sarcopenia Disease Knowledge [Срок оценки: Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)]
Cancer Self-Efficacy [Срок оценки: Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)]
Social Support [Срок оценки: Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)]
Anxiety [Срок оценки: Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)]
Cancer-Related Fatigue [Срок оценки: Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)]
Change in Quality of Life [Срок оценки: Baseline (T0), Week 6 (T1), Week 12 (T2), 3 months post-intervention (T3)]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет