Construction and Empirical Research of the Applicable Baduanjin Protocol for Patients With Colorectal Cancer Enterostomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- Exercise Benefits and Barriers Scale（EBBS）
研究概览
简要总结
The goal of this clinical trial is to understand the application effect of the applicable version of Baduanjin protocol in patients with enterostomy and verify the safety and efficacy of this protocol. The main questions it aims to answer are:
Can the applicable version of Baduanjin protocol be safely and effectively applied to patients with enterostomy? Researchers will compare the applicable version of the Baduanjin exercise with the walking exercise to see if the applicable version of the Baduanjin regimen is safe and effective for patients with enterostomy.
Participants will:
Apply the version of Baduanjin exercise or walking exercise five times a week for 12 weeks Patients signed in to the researchers of the project through forms such as exercise record sheets, videos uploaded on wechat, and records made through the keep app.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The disease diagnosis is colorectal cancer
- •At present, enterostomy is used for excretion, and the enterostomy time is more than one month
- •Age ≥ 18 years old
- •Have normal cognitive and expression abilities
- •Voluntarily participate in this study and have signed the informed consent form.
排除标准
- •In the past three months, I have participated in any intervention research or traditional Chinese medical exercise training programs (such as Tai Chi, Baduanjin, other Qigong exercises, etc.)
- •Patients with severe functional disorders of the heart, lungs, liver, kidneys and other organs
- •Mental abnormalities and language expression disorders
- •Patients with limb dysfunction who are unable to cooperate in completing the Baduanjin training
- •Various drainage tubes, PICC catheters, etc. were retained -
结局指标
主要结局
Exercise Benefits and Barriers Scale（EBBS）
时间窗: Baseline (Before enterostomy in patients with colorectal cancer), 4 weeks and 16 weeks after the operation
This scale consists of two sub-scales with a total of 43 items and two dimensions, namely the benefits of exercise (29 items) and movement disorders (14 items). The Liker 4-level scoring method was adopted, with 1 to 4 points assigned respectively from strongly disagree to strongly agree. The higher the score of the exercise benefit dimension in the calculation dimension, the more exercise benefits the participants perceive. The higher the score of the movement disorder dimension, the more the participants perceive movement disorders.
Pittsburgh Sleep Quality Index（PSQI）
时间窗: Baseline (Before enterostomy in patients with colorectal cancer) and at 4, 8, 12 and 16 weeks after the operation
This scale consists of 19 items and 7 dimensions, including subjective sleep quality, time to fall asleep, sleep duration, sleep efficiency, sleep quality, hypnotic drugs, and daytime functional quality, and is used to assess the sleep status of patients in the past month. The Liker 4-level scoring method was adopted, with the maximum total score being 21 points. The higher the score, the poorer the sleep quality of the patient.
Chinese Ostomy Adjustment Inventory（C-OAI）
时间窗: 4 weeks, 8 weeks, 12 weeks and 16 weeks after enterostomy
This scale consists of 20 items and 3 dimensions, namely persistent worry (9 items), acceptance (6 items), and a positive attitude towards life (5 items). The scale adopts the Likert 5-point scoring method. Among them, the items with positive implications range from "completely agree" to "completely disagree", with scores ranging from 4 to 0 respectively. Negative meaning items are scored in reverse, ranging from "completely agree" to "completely disagree", with scores ranging from 0 to 4 respectively. The total score of the scale is 80 points. The adaptation level is divided into three grades based on the scale score: \< 40 is the low adaptation level, 40-60 is the medium adaptation level, and \> 60 is the high adaptation level. The higher the score, the stronger the patient's adaptability to the stoma.
Cancer Fatigue Scale（CFS)
时间窗: Baseline (Before enterostomy in patients with colorectal cancer) and at 4, 8, 12 and 16 weeks after the operation
This scale was developed by Okuyama et al. in 2000. It consists of 15 items and is composed of three dimensions: the physical domain (7 items), the emotional domain (4 items), and the cognitive domain (4 items). It uses the Likert 5-level scoring method, ranging from none to very many, with scores ranging from 1 to 5 respectively. The total score ranges from 0 to 60 points. The higher the score, the more severe the patient's fatigue.
Stoma Quality of Life Scale（Stoma-QOL）
时间窗: 4 weeks, 8 weeks, 12 weeks and 16 weeks after enterostomy
This scale consists of 20 items, each of which contains 4 options: always, sometimes, rarely, and never, and is assigned a score of 1 to 4 respectively. The patient makes a choice based on their actual situation in the past month. The original score range of the scale is 20 to 80 points, which can be converted to 0 to 100 points. A score of no more than 30 in the quality of life standard is considered the worst level, 31 to 50 is a relatively poor level, 51 to 70 is a relatively high level, and 71 or more is the best level.
Exercise Benefits and Barriers Scale（EBBS）
时间窗: Baseline (Before enterostomy in patients with colorectal cancer), 4 weeks and 16 weeks after the operation
This scale consists of two sub-scales with a total of 43 items and two dimensions, namely the benefits of exercise (29 items) and movement disorders (14 items). The Liker 4-level scoring method was adopted, with 1 to 4 points assigned respectively from strongly disagree to strongly agree. The higher the score of the exercise benefit dimension in the calculation dimension, the more exercise benefits the participants perceive. The higher the score of the movement disorder dimension, the more the participants perceive movement disorders.
Pittsburgh Sleep Quality Index（PSQI）
时间窗: Baseline (Before enterostomy in patients with colorectal cancer) and at 4, 8, 12 and 16 weeks after the operation
This scale consists of 19 items and 7 dimensions, including subjective sleep quality, time to fall asleep, sleep duration, sleep efficiency, sleep quality, hypnotic drugs, and daytime functional quality, and is used to assess the sleep status of patients in the past month. The Liker 4-level scoring method was adopted, with the maximum total score being 21 points. The higher the score, the poorer the sleep quality of the patient.
Chinese Ostomy Adjustment Inventory（C-OAI）
时间窗: 4 weeks, 8 weeks, 12 weeks and 16 weeks after enterostomy
This scale consists of 20 items and 3 dimensions, namely persistent worry (9 items), acceptance (6 items), and a positive attitude towards life (5 items). The scale adopts the Likert 5-point scoring method. Among them, the items with positive implications range from "completely agree" to "completely disagree", with scores ranging from 4 to 0 respectively. Negative meaning items are scored in reverse, ranging from "completely agree" to "completely disagree", with scores ranging from 0 to 4 respectively. The total score of the scale is 80 points. The adaptation level is divided into three grades based on the scale score: \< 40 is the low adaptation level, 40-60 is the medium adaptation level, and \> 60 is the high adaptation level. The higher the score, the stronger the patient's adaptability to the stoma.
Cancer Fatigue Scale（CFS)
时间窗: Baseline (Before enterostomy in patients with colorectal cancer) and at 4, 8, 12 and 16 weeks after the operation
This scale was developed by Okuyama et al. in 2000. It consists of 15 items and is composed of three dimensions: the physical domain (7 items), the emotional domain (4 items), and the cognitive domain (4 items). It uses the Likert 5-level scoring method, ranging from none to very many, with scores ranging from 1 to 5 respectively. The total score ranges from 0 to 60 points. The higher the score, the more severe the patient's fatigue.
Stoma Quality of Life Scale（Stoma-QOL）
时间窗: 4 weeks, 8 weeks, 12 weeks and 16 weeks after enterostomy
This scale consists of 20 items, each of which contains 4 options: always, sometimes, rarely, and never, and is assigned a score of 1 to 4 respectively. The patient makes a choice based on their actual situation in the past month. The original score range of the scale is 20 to 80 points, which can be converted to 0 to 100 points. A score of no more than 30 in the quality of life standard is considered the worst level, 31 to 50 is a relatively poor level, 51 to 70 is a relatively high level, and 71 or more is the best level.
次要结局
未报告次要终点
研究者
Hui Yang
principal investigator
Sichuan Cancer Hospital and Research Institute