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Trial of Exercise Therapy in Familial Adenomatous Polyp (FAP)

NCT06641310 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-05-19

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Exercise 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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Michigan Rogel Cancer Center

    lead OTHER

Principal Investigators

  • Samara Rifkin, MD · University of Michigan Rogel Cancer Center

  • Lee Jones, Ph.D · City of Hope Medical Center

  • Carol Burke, MD · The Cleveland Clinic

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-13
Primary Completion
2028-05-31
Completion
2028-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06641310 on ClinicalTrials.gov