Facility-Based Multi-Modal Rehab vs. Home-Based Resistance Exercise for Quality of Life in Breast Cancer Survivors

Официальное название

Long-term Evaluation of the Body Composition and the Impact of Resistance and Relaxation Exercise on Muscle Mass and Quality of Life in Patients With Breast Cancer

Обзор

This study evaluates the comparative effectiveness of a multi-modal facility-based rehabilitation program (therapist-led resistance exercise and relaxation training) versus a self-directed home-based resistance exercise program in post-treatment breast cancer survivors. Participants in both intervention groups will complete a 16-week program consisting of two exercise sessions per week.The multimodal, therapist-led approach is hypothesized to result in superior improvements in physical performance and quality of life outcomes compared to self-directed home exercise

Подробное описание

Breast cancer treatments, including chemotherapy and radiotherapy, are associated with sarcopenia, a loss of muscle mass and strength, which increases toxicity, surgical complications, and mortality risk. While resistance exercise is known to mitigate muscle loss, the synergistic effect of adding relaxation techniques to address the psychological and neuromuscular tension of cancer treatment is not well established. This study investigates the comparative effectiveness of a multi-modal, facility-based program (elastic band resistance exercise combined with progressive muscle relaxation) versus a self-directed home-based elastic band resistance exercise program. The supervised, multi-modal intervention is hypothesized to offer superior results in muscle mass, physical performance, and quality of life compared to isolated resistance training.

Вмешательства

• Поведенческое Multimodal Resistance and Relaxation Training
  A 16-week multimodal program consisting of resistance exercise and relaxation training. Participants undergo two sessions per week: one weekly session is conducted under the supervision of a physical therapist at Taipei Tzu Chi Hospital, and one weekly session is self-directed and performed by the participant in a home setting. The resistance exercise portion utilizes progressive elastic band training
• Поведенческое Home-Based Resistance Exercise Training
  A 16-week self-directed resistance exercise program. The intervention consists of two sessions per week performed independently by the participant in a home setting. The exercise regimen utilizes progressive elastic band training and is conducted without direct therapist supervision

Первичные конечные точки

• Change from Baseline in Skeletal Muscle Mass Index (SMI) [Срок оценки: 16 weeks]

Вторичные конечные точки (10)

• Functional Battery: Change from Baseline in Handgrip Strength [Срок оценки: 16 weeks]
• Functional Battery: Change from Baseline in 4-Meter Gait Speed [Срок оценки: 16 weeks]
• Functional Battery: Change from Baseline in Timed Up & Go (TUG) Test [Срок оценки: 16 weeks]
• Functional Battery: Change from Baseline in 30-Second Chair Stand Test [Срок оценки: 16 weeks]
• Body Composition: Change from Baseline in Body Fat Mass [Срок оценки: 16 weeks]
• Body Composition: Change from Baseline in Limb-to-Trunk Lean Mass Ratio [Срок оценки: 16 weeks]
• Body Composition: Change from Baseline in Arm-to-Leg Lean Mass Ratio [Срок оценки: 16 weeks]
• HRQoL: Change from Baseline in EORTC QLQ-C30 Score [Срок оценки: 16 weeks]
• HRQoL: Change from Baseline in EORTC QLQ-BR45 Score [Срок оценки: 16 weeks]
• HRQoL: Change from Baseline in SarQoL Score [Срок оценки: 16 weeks]

Критерии участия

Критерии включения

• Histologically confirmed primary breast cancer
• Stage I-III non-metastatic breast cancer following lumpectomy or mastectomy
• Completed adjuvant chemotherapy (with or without radiotherapy)
• Age ≥ 18 years
• Able to understand and follow the study protocol
• Willingness to attend facility-based exercise training.

Критерии исключения

• Metastatic (Stage IV) breast cancer
• Morbid obesity (BMI > 40 kg/m²)
• Uncontrolled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 99 mmHg)
• Presence of implantable medical devices (e.g., pacemakers, nerve stimulators)
• Presence of metallic surgical implants (e.g., total hip or knee replacements) that interfere with assessment devices
• Contraindications for resistance training (e.g., acute infectious disease, severe cardiac disease, severe respiratory insufficiency)
• Concurrent malignant diseases
• Current participation in intense systematic exercise training (defined as at least 1 hour, twice per week)
• Previous participation in an exercise intervention clinical trial.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation — New Taipei City

Идентификаторы

NCT: NCT07465393 · 13-IRB110 · TCRD-TPE-114-C1-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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