Effect of Exercise on Bowel Function in Colorectal Cancer Survivors

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05420870
• Other study ID #: 4-2022-0338
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Low Anterior Resection Syndrome

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)