Construction and Empirical Research of the Applicable Baduanjin Protocol for Patients With Colorectal Cancer Enterostomy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSichuan Cancer Hospital and Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Baduanjin for patients with enterostomy

    Other intervention

    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.

Treatment groups

258 Participants
are divided into 2 treatment groups
Group A: Baduanjin for patients with enterostomyExperimental treatment 1 intervention
Group B: walking exerciseNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Exercise Benefits and Barriers Scale(EBBS)

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.

Time frame
Baseline (Before enterostomy in patients with colorectal cancer), 4 weeks and 16 weeks after the operation
2

Pittsburgh Sleep Quality Index(PSQI)

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.

Time frame
Baseline (Before enterostomy in patients with colorectal cancer) and at 4, 8, 12 and 16 weeks after the operation
3

Chinese Ostomy Adjustment Inventory(C-OAI)

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.

Time frame
4 weeks, 8 weeks, 12 weeks and 16 weeks after enterostomy
4

Cancer Fatigue Scale(CFS)

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.

Time frame
Baseline (Before enterostomy in patients with colorectal cancer) and at 4, 8, 12 and 16 weeks after the operation

Secondary outcomes

Other outcomes

1

Hemoglobin(Hb)

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.

Time frame
Baseline (Before enterostomy in patients with colorectal cancer), 5 days after surgery, 4 weeks and 12 weeks after enterostomy
2

Red Blood Cell(RBC)

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.

Time frame
Baseline (Before enterostomy in patients with colorectal cancer), 5 days after surgery, 4 weeks and 12 weeks after enterostomy
3

Lymphocyte(LY)

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.

Time frame
Baseline (Before enterostomy in patients with colorectal cancer), 5 days after surgery, 4 weeks and 12 weeks after enterostomy
4

White Blood Cell(WBC)

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.

Time frame
Baseline (Before enterostomy in patients with colorectal cancer), 5 days after surgery, 4 weeks and 12 weeks after enterostomy

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: