Move to Improve: Investigating the Feasibility of Embedding Physical Activity Into Routine Breast Cancer Care in Indonesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Physical fitness
研究概览
简要总结
The goal of this clinical trial is to learn the impact and implementation of home-based aerobic and resistance training for patients with breast cancer in Indonesia. The main questions it aims to answer are:
- Does the home-based aerobic and resistance training improve physical fitness, fatigue, and quality of life of patients with breast cancer?
- Are the benefits of aerobic and resistance training mediated by inflammatory level changes?
- What are the barriers and facilitators in implementing the home-based aerobic and resistance training?
- Is the home-based aerobic and resistance training feasible to be implemented in Indonesia's setting?
To answer those questions, participants will:
- Conduct home-based aerobic and resistance training with supervision.
- Visit the hospital once every 4 weeks for their routine visits.
- Undergo physical fitness test before and after 12 weeks using treadmill test, as well as interviews to assess fatigue, quality of life, and intervention acceptability.
- Keep a diary to record the aerobic and resistance training at home.
- Undergo routine monitoring by phone every week with the research team.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with stage I-III hormone-receptor positive breast cancer
- •Eastern Cooperative Oncology Group (ECOG) score ≤1
- •Had completed primary treatment (e.g., surgery, chemotherapy, and radiotherapy), except for hormonal treatment
- •Within 5 years of diagnosis
- •Able to perform moderate-intensity physical activity as determined by their oncologist and care team
- •Able to read and write in Indonesian
- •Willing to provide written informed consent.
排除标准
- •Had an ejection fraction of <50%
- •Evidence of cardiac disease, severe musculoskeletal problems, or other contraindications for exercise.
研究组 & 干预措施
Physical activity intervention
干预措施: 12weeks of home-based aerobic (pedometer-driven walking) and resistance training using therapeutic bands (Behavioral)
结局指标
主要结局
Physical fitness
时间窗: Baseline and post-intervention (12 weeks)
Physical fitness was measured using a submaximal treadmill test with the modified Bruce protocol. Treadmill speed and inclination were automatically increased every 3 min (test stage). The test was terminated when participants reached volitional fatigue. Physical fitness was classified as low, fair, average, and good, based on patients' age, treadmill test duration, and predicted VO2peak.
Fatigue
时间窗: Baseline and post-intervention (12 weeks)
Fatigue was assessed using the Indonesian version of Fatigue Severity Scale (FSS). A higher score on the FSS indicated a more severe level of fatigue. The FSS was also classified as no-to-mild fatigue (FSS \<4.0) and severe fatigue (≥4.0).
Health-related quality of life
时间窗: Baseline and post-intervention (12 weeks)
Health-related quality of life was assessed using the Indonesian version of the EORTC Quality of Life Questionnaire (QLQ-C30). The EORTC QLQ-C30 consists of global health status, functional scales, and symptom scales. A higher score indicates better health for global health status and functional scales, but represents a higher level of burden for symptom scales.
次要结局
- Inflammatory biomarkers(Baseline and post-intervention (12 weeks))
- Intervention acceptability(Post-intervention (12 weeks))
- Intervention barriers and facilitators(Post-intervention (12 weeks))
研究者
Susanna Hilda Hutajulu
Susanna Hilda Hutajulu, MD, PhD
Gadjah Mada University