National Taiwan University Hospital Hsin-Chu Branch.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Quality of life of cancer patients(EORTC QLQ-C30)
研究概览
简要总结
The purpose of this study was to explore the 12-week effectiveness of home exercise intervention for colorectal cancer patients in improving fatigue, sleep, muscle endurance, and quality of life.
A. Explore the effect of "12-week home exercise intervention" in improving the fatigue of colorectal cancer patients.
B. Explore the effect of "12-week home exercise intervention" in improving the sleep quality of patients with colorectal cancer.
C. Explore the effect of "12-week home exercise intervention" in improving the muscle endurance of patients with colorectal cancer.
D. Explore the effect of "12-week home exercise intervention" in improving the quality of life of colorectal cancer patients.
详细描述
The study was conducted at the colon and rectal outpatient departments. A randomized controlled trial design was adopted. The participants were divided into an interventional group and a conventional therapy control group based on block randomization in a 1:1 ratio. Data were collected when patients returned to the clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A. Inclusion criteria
- •Above the age of 20, with colorectal cancer pathological stage in situ, I, II, and III.
- •Coherent, with no mental abnormalities.
- •Able to read Mandarin or communicate in Mandarin and Taiwanese to complete the questionnaire.
- •Provided informed consent.
- •No physical disabilities.
排除标准
- •Acute inflammation of the limbs and joints.
- •Previous abdominal surgery within 3 months.
- •Symptomatic cardiovascular events.
- •Long-term anti-depressant drug use.
- •Unilateral restrictions of the upper or lower limbs.
- •History of medium- or high-intensity exercise for more than half a year.
- •Having colostoma or ileostoma.
结局指标
主要结局
Quality of life of cancer patients(EORTC QLQ-C30)
时间窗: 24rd month after recruited
This questionnaire measures the general quality of life of cancer patients. There are 30 questions in total, including questions on physical functioning (5 questions), role function (2 questions), emotional functioning (4 questions),and cognitive functioning (2 questions), as well as, overall quality of life and health status (2 questions). And common symptoms such as fatigue (3 questions), pain (2 questions), nausea and vomiting (2 questions), dyspnea, insomnia, loss of appetite, constipation, diarrhea, and financial problems (one question each).
Quality of life of cancer patients(EORTC QLQ-CR29)
时间窗: 24rd month after recruited
The acceptance conditions of this study exclude cases of stomy; therefore, there is no score for stomy. Among these 21 questions, only body image, anxiety, weight, and sex are functional scales, and all the others are symptomatic. The higher the score, the more serious the symptom.
次要结局
- Exercise Counseling and Programming Preferences(24rd month after recruited)
- 3-d Physical Activity Record, 3-dPAR(3rd month after recruited)
- 30-second Chair sit-to-stand, 30-s STS(3rd month after recruited)
- Pittsburgh Sleep Quality Index (PSQI)(24rd month after recruited)
- Brief Fatigue Inventory-Taiwanese (BFI-T)(24rd month after recruited)
- Six-Minute Walk Test, 6MWT(3rd month after recruited)