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

NCT07172087 | Not Yet Recruiting

• 1 other identifier: KY-2025-248-02
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Baduanjin

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

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

Other Outcomes (6)

• Hemoglobin(Hb)

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

• Red Blood Cell(RBC)

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

• Lymphocyte(LY)

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

Study Arms (2)

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.

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.

Interventions

Baduanjin for patients with enterostomy OTHER

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.

Baduanjin for patients with enterostomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead

Study Sites (1)

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, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Enterostomy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative; Ostomy

Central Study Contacts

Hui Yang

CONTACT

+8618908191080; yanghui1@scszlyy.org.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 15, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)