Colorectal Cancer
Conditions
Keywords
Baduanjin
Brief summary
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.
Interventions
OTHERBaduanjin for patients with enterostomy
Modified Baduanjin exercise: a standardized, low-to-moderate intensity qigong regimen consisting of eight sequential movements combined with diaphragmatic breathing. The program excludes any additional resistance or aerobic training and is compared with routine walking exercise only.
Sponsors
Sichuan Cancer Hospital and Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. The disease diagnosis is colorectal cancer 2. At present, enterostomy is used for excretion, and the enterostomy time is more than one month 3. Age ≥ 18 years old 4. Have normal cognitive and expression abilities 5. Voluntarily participate in this study and have signed the informed consent form.
Exclusion criteria
1. 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.) 2. Patients with severe functional disorders of the heart, lungs, liver, kidneys and other organs 3. Mental abnormalities and language expression disorders 4. Patients with limb dysfunction who are unable to cooperate in completing the Baduanjin training 5. Various drainage tubes, PICC catheters, etc. were retained -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise Benefits and Barriers Scale（EBBS） | 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） | 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） | 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) | 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） | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin(Hb) | Baseline (Before enterostomy in patients with colorectal cancer), 5 days after surgery, 4 weeks and 12 weeks after enterostomy | The protein in red blood cells responsible for transporting oxygen is used to assess anemia or polycythemia; Blood test indicators are collected from the examination results required during the treatment period and do not need to be collected separately outside of the treatment. |
| Total Protein(TP) | Baseline (Before enterostomy in patients with colorectal cancer), 5 days after surgery, 4 weeks and 12 weeks after enterostomy | The total sum of all proteins in the plasma, including albumin and globulin, abnormalities may indicate liver disease, kidney disease or immune disorders. Blood test indicators are collected from the examination results required during the treatment period and do not need to be collected separately outside of the treatment. |
| Red Blood Cell(RBC) | Baseline (Before enterostomy in patients with colorectal cancer), 5 days after surgery, 4 weeks and 12 weeks after enterostomy | The most numerous cells in the blood are responsible for carrying oxygen. Abnormal values may indicate anemia, dehydration or bone marrow problems; Blood test indicators are collected from the examination results required during the treatment period and do not need to be collected separately outside of the treatment. |
| Lymphocyte(LY) | Baseline (Before enterostomy in patients with colorectal cancer), 5 days after surgery, 4 weeks and 12 weeks after enterostomy | One type of white blood cell, it is an important component of the immune system. An increase or decrease in it may indicate infection, inflammation or immune disease. Blood test indicators are collected from the examination results required during the treatment period and do not need to be collected separately outside of the treatment. |
| White Blood Cell(WBC) | Baseline (Before enterostomy in patients with colorectal cancer), 5 days after surgery, 4 weeks and 12 weeks after enterostomy | An increase in the total number usually indicates infection or inflammation, while a decrease may be seen in bone marrow suppression or immune deficiency. Blood test indicators are collected from the examination results required during the treatment period and do not need to be collected separately outside of the treatment. |
| Prealbumin(PALB) | Baseline (Before enterostomy in patients with colorectal cancer), 5 days after surgery, 4 weeks and 12 weeks after enterostomy | It is used to assess nutritional status and liver function. A decrease may indicate malnutrition or inflammation. Blood test indicators are collected from the examination results required during the treatment period and do not need to be collected separately outside of the treatment. |
Countries
China
Contacts
Primary ContactHui Yang
Outcome results
None listed