RecruitingNot ApplicableNCT06641310

Trial of Exercise Therapy in Familial Adenomatous Polyp (FAP)

Phase 1a/b Trial of Exercise Therapy in Familial Adenomatous Polyp (FAP)

Sponsor

University of Michigan Rogel Cancer Center

Enrollment

32 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

Familial Adenomatous Polyposis

Summary

The purpose of this phase 1a/b trial is to find out what amount of exercise would be best to use for preventing recurrence of colorectal polyps. It involves following one of four different amounts of exercise regimens on a treadmill for 26 weeks. A treadmill will be placed in each study participant's home for the duration of the study. The exercise regimen will be personalized for each participant and monitored remotely by exercise personnel. The in-person study visits occur during the usual standard of care endoscopy exam and during a follow-up exam that is 26 weeks later. Small rectal tissue biopsies, about the size of a grain of rice, will be taken before and after 26 weeks of exercise. The study visits also involve questionnaires, a stool sample, and a blood sample. This study will inform the design of larger, future trials to investigate whether or not recurrence of polyps can be achieved with exercise.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a regular exercise program (using a treadmill at home) can reduce the number of rectal polyps in people with familial adenomatous polyposis (FAP), a hereditary condition that causes many polyps in the colon and rectum that can become cancerous. **You may be eligible if...** - You have FAP confirmed by genetic testing or having more than 50 colorectal polyps - You still have your rectum intact and have at least 5 rectal polyps larger than 2 mm - You are 18 years or older - You are currently inactive (less than 60 minutes of moderate exercise per week) - You have space for a treadmill or access to one nearby - You have internet or Wi-Fi access - You have no contraindications to exercise **You may NOT be eligible if...** - You have had your entire rectum removed - Your biopsy showed high-grade cancer or pre-cancer - You have had pelvic radiation - You are pregnant - You have serious heart, liver, kidney, or psychiatric conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREExercise Therapy

Exercise therapy comprising treadmill walking will be administer by exercise physiologists via a study-kit which includes a smart-watch (activity tracker), heart rate monitor, blood pressure cuff, body composition scale, and e-tablet for remotely monitoring your exercise. The trials will test 3 exercise levels (150, 225, and 300 minutes per week), with one de-escalation exercise level of 90 minutes per week if needed.