Colorectal CancerNCT05420870
Effect of Exercise on Bowel Function in Colorectal Cancer Survivors
A study testing exercise in people with Colorectal Cancer and Low Anterior Resection Syndrome, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 69 years
- Conditions the study is for
- Colorectal Cancer, Low Anterior Resection Syndrome
- What is being tested?
- exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 May 2022to 19 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
About this study
Official title: A Randomized Controlled Trial to Examine the Effect of Exercise on Bowel Function in Colorectal Cancer Survivors
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
- Being tested
- exercise
- Medical subject headings
- Colorectal Neoplasms, Low Anterior Resection Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Not described Receives: Behavioral: exercise |
| Usual care group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: endline (7 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start23 May 2022
- Primary completion12 Mar 2024
- Study completion19 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jae Jun Park, Principal investigator, Dept. of Internal Medicine, Division of Gastroenterology, Sinchon sevarance Hospital, Younsei university College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05420870
- Sponsor's protocol ID
- 4-2022-0338
- Status last verified
- Jul 2024
- First submitted
- 26 May 2022
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Examine the Effect of Exercise on Bowel Function in Colorectal Cancer Survivors
- ClinicalTrials.gov ID
- NCT05420870
- Acronym / sponsor ID
- 4-2022-0338
- Conditions
- Colorectal Cancer, Low Anterior Resection Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 23 May 2022 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 19 Jun 2024 (actual)
- First posted
- 15 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: exercise |
| Usual care group | No intervention | – |
Who may qualify
- Ages
- 19 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exerciseSix 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 | Behavioural | Exercise group |
Primary outcome
Anorectal manometry
Time frame: Baseline (0 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jae Jun Park principal investigator
Dept. of Internal Medicine, Division of Gastroenterology, Sinchon sevarance Hospital, Younsei university College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Colorectal Cancer and Low Anterior Resection Syndrome, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anorectal manometry (time frame: Baseline (0 week)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.