Colorectal CancerNCT07172087
Construction and Empirical Research of the Applicable Baduanjin Protocol for Patients With Colorectal Cancer Enterostomy
A study testing Baduanjin for patients with enterostomy in people with Colorectal Cancer, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Baduanjin for patients with enterostomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteChina
- Study dates
- Sep 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, Afffliated Cancer Hospital of University of Electronic Science and Technology of China
Chengdu, Sichuan, 610041
Hui Yang, 8618908191080, yanghui1@scszlyy.org.cn
About this study
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.
Read more
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.
- Conditions
- Colorectal Cancer
- Being tested
- Baduanjin for patients with enterostomy
- Keywords
- Baduanjin
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baduanjin for patients with enterostomyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Baduanjin for patients with enterostomy | Experimental | The validated version of Baduanjin intervention plan for colorectal cancerpatients with enterostomy was adopted, 5 times a week, 15 minutes each time, for 12 weeks. Receives: Other: Baduanjin for patients with enterostomy |
| walking exercise | No intervention | A walking exercise was compared with the version of Baduanjin suitable for enterostomy patients, administered five times a week for 30 minutes each time for 12 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Before enterostomy in patients with colorectal cancer), 4 weeks and 16 weeks after the operation
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.
Measured: Baseline (Before enterostomy in patients with colorectal cancer) and at 4, 8, 12 and 16 weeks after the operation
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.
Measured: 4 weeks, 8 weeks, 12 weeks and 16 weeks after enterostomy
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.
Measured: Baseline (Before enterostomy in patients with colorectal cancer) and at 4, 8, 12 and 16 weeks after the operation
Stoma Quality of Life Scale（Stoma-QOL）
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.
Measured: 4 weeks, 8 weeks, 12 weeks and 16 weeks after enterostomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Yang, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172087
- Sponsor's protocol ID
- KY-2025-248-02
- Status last verified
- Sep 2025
- First submitted
- 2 Sep 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Empirical Research of the Applicable Baduanjin Protocol for Patients With Colorectal Cancer Enterostomy
- ClinicalTrials.gov ID
- NCT07172087
- Acronym / sponsor ID
- KY-2025-248-02
- Conditions
- Colorectal Cancer
- Keywords
- Baduanjin
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baduanjin for patients with enterostomy | Experimental | Other: Baduanjin for patients with enterostomyThe validated version of Baduanjin intervention plan for colorectal cancerpatients with enterostomy was adopted, 5 times a week, 15 minutes each time, for 12 weeks. |
| walking exercise | No intervention | –A walking exercise was compared with the version of Baduanjin suitable for enterostomy patients, administered five times a week for 30 minutes each time for 12 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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 -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baduanjin for patients with enterostomyModified 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. | Other | Baduanjin for patients with enterostomy |
Primary outcome
Exercise Benefits and Barriers Scale（EBBS）
Time frame: 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）
Time frame: 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）
Time frame: 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)
Time frame: 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）
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baduanjin for patients with enterostomy in people with Colorectal Cancer, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui Yang (+8618908191080, yanghui1@scszlyy.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Benefits and Barriers Scale（EBBS） (time frame: Baseline (Before enterostomy in patients with colorectal cancer), 4 weeks and 16 weeks after the operation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.