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Clinical Trials/NCT05420870
NCT05420870
Completed
Not Applicable

A Randomized Controlled Trial to Examine the Effect of Exercise on Bowel Function in Colorectal Cancer Survivors

Yonsei University1 site in 1 country50 target enrollmentMay 23, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Colorectal Cancer
Sponsor
Yonsei University
Enrollment
50
Locations
1
Primary Endpoint
Anorectal manometry
Status
Completed
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
May 23, 2022
End Date
June 19, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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
  • Three months after chemo and radiation therapy.
  • Six month after stoma take-down
  • Colorectal cancer patients with a LARS (Low Anterior Reservation Syndrome) questionnaire score of 21 or higher

Exclusion Criteria

  • Subjects who have problems reading or understanding Korean or who have problems communicating with researchers
  • Subjects who plan to undergo surgery at the same time other than colorectal cancer surgery
  • Metastatic colorectal cancer patients.
  • Subjects who have stoma
  • People who are difficult to exercise in the judgment of the medical staff

Outcomes

Primary Outcomes

Anorectal manometry

Time Frame: endline (7 week)

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.

Study Sites (1)

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