Effect of Exercise on Bowel Function in Colorectal Cancer Survivors

NCT05420870 | Completed

• 1 other identifier: 4-2022-0338
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Low Anterior Resection Syndrome

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Study Arms (2)

Exercise group

EXPERIMENTAL

Behavioral: exercise

Usual care group

NO INTERVENTION

Interventions

exercise BEHAVIORAL

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

Exercise group

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Low Anterior Resection Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jae Jun Park

  Dept. of Internal Medicine, Division of Gastroenterology, Sinchon sevarance Hospital, Younsei university College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 15, 2022
• Study Start: May 23, 2022
• Primary Completion: March 12, 2024
• Study Completion: June 19, 2024
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)