Actively Recruiting
Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer
Led by AdventHealth Translational Research Institute · Updated on 2025-07-03
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
AdventHealth Translational Research Institute
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the effects of aerobic exercise training compared to attention control on intermuscular adipose tissue in colorectal cancer survivors. The trial focuses on adults aged 18 years or older who have had stage I, II, or III colon or rectal cancer and have completed surgery and other cancer treatments. The study is designed to understand how exercise influences skeletal muscle remodeling in this population. Participants are randomly assigned to one of two groups. One group will engage in aerobic exercise at a dose of 225 minutes per week at moderate to vigorous intensity. The other group will participate in static stretching involving eight major muscle groups, serving as an attention control. The study includes a double-masked design to compare these interventions over the treatment period. Throughout the 12-week study, participants will be closely monitored. Researchers will measure whole-body intermuscular adipose tissue as the primary outcome. Participants will provide written consent and approval from a healthcare professional before enrolling. The study also includes readiness assessments for exercise and tracks adherence and safety during the trial. The total duration and follow-up details are based on the defined study period ending in March 2027.
CONDITIONS
Brief Title
Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed stage I, II, or III colon or rectal cancer
- Completed surgical resection with curative intent
- Completed other cancer-directed treatments
- Engage in less than 150 minutes per week of moderate- to vigorous-intensity structured endurance exercise
- No planned major surgery during the study period
- Readiness to exercise, confirmed by a modified Physical Activity Readiness Questionnaire
- Ability to provide written informed consent
- Written approval from a qualified healthcare professional
- Willingness to be randomized
You will not qualify if you...
- Evidence of metastatic or recurrent colorectal cancer
- Currently receiving active treatment for other (non-colorectal) cancers
- Scheduled to receive additional postoperative cancer-directed treatments
- Currently pregnant, breastfeeding, or planning pregnancy within 24 weeks
- Participation in another study with conflicting outcomes
- Contraindications to magnetic resonance imaging
- Dietary restrictions limiting tolerance of a mixed meal challenge
- Cardiovascular, pulmonary, orthopedic, neurologic, psychiatric, or other conditions that may prevent safe participation or compliance
- Any other condition or situation that could negatively affect safety or study compliance as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants engage in either aerobic exercise at a dose of 225 minutes per week or static stretching as part of the study interventions.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 1 location
1
AdventHealth
Orlando, Florida, United States, 32804
Actively Recruiting
Research Team
J
Justin C. Brown, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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