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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date June 2022
Source Yonsei University
Contact Jae Jun Park
Phone 82-2-2228-1993
Email jaejpark@yuhs.ac
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Intervention

Behavioral:
exercise
Six weeks of exercise intervention To meet weekly 150 min of moderate to vigorous physical activity and twice weekly strength exercise General description of the exercise program Main goal of the supervised exercise (1 hour per session, twice a week) are three folds. 1) Instruct participants to correctly perform prescribed exercises. 2) Encourage participants to be compliant to exercise program. 3) Participants were encouraged to hand in their exercise diary Main goal of the home-based exercise is to perform calisthenics exercise daily. Participants were encouraged to perform at least one set of exercise (8-12 different exercises) and stretching (At least 3 days per week, but preferably most of the days) daily Basic 8 exercises which increase ROM and strength of shoulder, lower back, Hip, Knee and ankle Additional 4 exercise to increase core strength and stability

Locations

Country Name City State
Korea, Republic of Yonsei University Health System, Severance Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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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