The Effect of Home Based Walking Exercise on Fatigue, Anxiety, Depression, Sleep Quality, Circadian Rhythms and Quality of Life in Patients With Gastric Cancer Undergoing Gastrectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Quality of Life (EORTC QLQ-C30 )
研究概览
简要总结
This study will investigate the effectiveness of a rehabilitation program in improving fatigue, negative emotions , sleep quality, circadian rhythms and quality of life in patients with gastric cancer undergoing gastrectomy in Taiwan.
Hypothesis:
- The fatigue in exercise group is significant improving than usual-care group at 1st, 2nd, 3rd, 6th, 12th, 24th and 36th month.
- The negative emotions in exercise group is significant improving than usual-care group at 1st, 2nd, 3rd, 6th, 12th, 24th and 36th month.
- The sleep quality in exercise group is significant improving than usual-care group at 1st, 2nd, 3rd, 6th, 12th, 24th and 36th month.
- The quality of life in exercise group is significant improving than usual-care group at 1st, 2nd,3rd, 6th, 12th, 24th and 36th month.
详细描述
This study will investigate the effectiveness of a rehabilitation program in improving fatigue, negative emotions , sleep quality, circadian rhythms and quality of life in patients with gastric cancer undergoing gastrectomy in Taiwan.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •After undergoing surgery and clinically diagnosed as gastric cancer.
- •Adults over 20 years old.
- •Hemoglobin (above 10 g/dL).
- •Clear consciousness and could communicate in either Mandarin or Taiwanese, and were not cognitively impaired were included.
- •No lower limb disability and able to walk on their own.
排除标准
- •Suspected or confirmed bone metastasis.
- •Poorly controlled cardiovascular disease such as heart failure, arrhythmia, angina, myocardial infarction, chest pain during activities or rest in the past three months, and valvular heart disease using anticoagulants.
- •Poorly diabetes controlled, glycosylated hemoglobin (HbA1C)>9%, blood sugar higher than 250mg/dl or lower than 80mg/dl.
- •Those with poor blood pressure control, systolic blood pressure greater than 160mmHg or diastolic blood pressure than 100mmHg when quiet, and heart rate is greater than 100bpm when quiet.
- •Diagnosed as recurrent depression.
- •Regular exercise above moderate intensity, such as 150 minutes per week in the past three months.
结局指标
主要结局
Quality of Life (EORTC QLQ-C30 )
时间窗: 1st month after recruited
The EORTC QLQ-C30 :This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-C30 consists of three subscales with 30 questions. The EORTC QLQ-C30 have three subscales in the scale include functioning scales (15 questions), symptom scales (13 questions), and global health status (2 questions). The reliability and validity of Cronbach'α was 0.81-0.94. The functional scale and the global health status , the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.
Quality of Life (EORTC QLQ-C30)
时间窗: 36th month after recruited
The EORTC QLQ-C30 :This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-C30 consists of three subscales with 30 questions. The EORTC QLQ-C30 have three subscales in the scale include functioning scales (15 questions), symptom scales (13 questions), and global health status (2 questions). The reliability and validity of Cronbach'α was 0.81-0.94. The functional scale and the global health status , the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.
Quality of Life (EORTC QLQ-STO22)
时间窗: 36th month after recruited
The EORTC QLQ-STO22:This scale is measured by the respondent self-assessed the frequency of various problems in the past week. The EORTC QLQ-STO22 consists of one subscale with 22 questions.The EORTC QLQ-STO22 scale include symptom scales (22 questions) The Cronbach'α was 0.70-0.94.The lower the score in the symptom scale, the better the quality of life.
次要结局
- fatigue(Brief Fatigue Inventory-Taiwan , BFI-T)(36th month after recruited)
- Emotional distress( Hospital Anxiety and Depression Scale, HADS)(36th month after recruited)
- Circadian rhythms(using Actigraph)(36th month after recruited)
- sleep quality(Pittsburgh Sleep Quality Index and using Actigraph)(36th month after recruited)