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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change from Baseline in Skeletal Muscle Mass Index (SMI)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Facility-Based Resistance and Relaxation
Participants engage in a 16-week multimodal rehabilitation program at Taipei Tzu Chi Hospital. The intervention is comprised of one weekly therapist-led session and one weekly self-directed home session (totaling two sessions per week) involving elastic band resistance exercise and relaxation training
干预措施: Multimodal Resistance and Relaxation Training (Behavioral)
Home-Based Resistance Exercise
Participants perform a 16-week self-directed elastic band resistance exercise program. The intervention consists of two weekly home-based sessions using elastic bands, performed without therapist supervision.
干预措施: Home-Based Resistance Exercise Training (Behavioral)
结局指标
主要结局
Change from Baseline in Skeletal Muscle Mass Index (SMI)
时间窗: 16 weeks
Skeletal Muscle Mass Index (SMI) is calculated by dividing total skeletal muscle mass (kg), as measured by bioelectrical impedance analysis (ACCUNIQ BC720; SELVAS Healthcare), by the square of the height (m²). Higher scores indicate greater muscle mass relative to height (better outcome).
次要结局
- Functional Battery: Change from Baseline in 30-Second Chair Stand Test(16 weeks)
- Functional Battery: Change from Baseline in Handgrip Strength(16 weeks)
- Functional Battery: Change from Baseline in 4-Meter Gait Speed(16 weeks)
- Functional Battery: Change from Baseline in Timed Up & Go (TUG) Test(16 weeks)
- Body Composition: Change from Baseline in Body Fat Mass(16 weeks)
- Body Composition: Change from Baseline in Limb-to-Trunk Lean Mass Ratio(16 weeks)
- Body Composition: Change from Baseline in Arm-to-Leg Lean Mass Ratio(16 weeks)
- HRQoL: Change from Baseline in EORTC QLQ-C30 Score(16 weeks)
- HRQoL: Change from Baseline in EORTC QLQ-BR45 Score(16 weeks)
- HRQoL: Change from Baseline in SarQoL Score(16 weeks)
研究者
Valeria Chiu
Attending Physician
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation