Effect of Exercise on Bowel Function in Colorectal Cancer Survivors
Primary Purpose
Colorectal Cancer, Low Anterior Resection Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Colorectal Cancer
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
Sites / Locations
- Yonsei University Health System, Severance HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise group
Usual care group
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05420870
Brief Title
Effect of Exercise on Bowel Function in Colorectal Cancer Survivors
Official Title
A Randomized Controlled Trial to Examine the Effect of Exercise on Bowel Function in Colorectal Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 23, 2022 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Low Anterior Resection Syndrome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise group
Arm Type
Experimental
Arm Title
Usual care group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
Anorectal manometry
Description
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.
Time Frame
Baseline (0 week)
Title
Anorectal manometry
Description
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.
Time Frame
endline (7 week)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jae Jun Park
Phone
82-2-2228-1993
Email
jaejpark@yuhs.ac
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae Jun Park
Organizational Affiliation
Dept. of Internal Medicine, Division of Gastroenterology, Sinchon sevarance Hospital, Younsei university College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei University Health System, Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Jun Park
Phone
82-2-2228-1993
Email
jaejpark@yuhs.ac
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Exercise on Bowel Function in Colorectal Cancer Survivors
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