Colorectal Cancer Clinical Trial
Official title:
A Randomized Controlled Trial to Examine the Effect of Exercise on Bowel Function in Colorectal Cancer Survivors
NCT number | NCT05420870 |
Other study ID # | 4-2022-0338 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 23, 2022 |
Est. completion date | January 2023 |
Verified date | June 2022 |
Source | Yonsei University |
Contact | Jae Jun Park |
Phone | 82-2-2228-1993 |
jaejpark[@]yuhs.ac | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The survival rate of colorectal cancer patients is increasing due to the development of medical technology. However, many colorectal cancer survivors (CRCs) have bowel dysfunction unlike other cancer survivors. After bowel dysfunction of CRCs was known, many previous studies were conducted to improve bowel dysfunction. Medication, probiotics, Biofeedback training (BFT), Kegel exercise, and sacral nerve stimulation were the methods of intervention research to improve bowel movements in CRCs. Research on randomized control trial of BFT and Kegel exercise is very insufficient. Surgery, chemo, and radiation have a lot of influence on the bowel process of CRCs. In particular, damage to the abdominal muscles, pelvic floor muscles, and autonomic nervous system can also be caused by secondary symptoms such as increased fatigue, reduced physical strength, and musculoskeletal diseases. Therefore, the investigators examine that exercise which can improve fatigue, physical fitness, and musculoskeletal disease affects bowel symptoms of colon cancer survivors.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | January 2023 |
Est. primary completion date | January 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 69 Years |
Eligibility | Inclusion Criteria: 1. Adults aged 19 to 70 who have been diagnosed with Sigmoid colon cancer or rectal cancer have surgery for 6 months or more to less than 3 years 2. Three months after chemo and radiation therapy. 3. Six month after stoma take-down 4. Colorectal cancer patients with a LARS (Low Anterior Reservation Syndrome) questionnaire score of 21 or higher Exclusion Criteria: 1. Subjects who have problems reading or understanding Korean or who have problems communicating with researchers 2. Subjects who plan to undergo surgery at the same time other than colorectal cancer surgery 3. Metastatic colorectal cancer patients. 4. Subjects who have stoma 5. People who are difficult to exercise in the judgment of the medical staff |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Yonsei University Health System, Severance Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anorectal manometry | Anorectal manometry is a test performed to evaluate patients with constipation or fecal incontinence. This test measures the pressures of the anal sphincter muscles, the sensation in the rectum, and the neural reflexes that are needed for normal bowel movements. | Baseline (0 week) | |
Primary | Anorectal manometry | Anorectal manometry is a test performed to evaluate patients with constipation or fecal incontinence. This test measures the pressures of the anal sphincter muscles, the sensation in the rectum, and the neural reflexes that are needed for normal bowel movements. | endline (7 week) |
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