Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to quantify the effects of aerobic exercise training compared to attention control on intermuscular adipose tissue in colorectal cancer survivors.

Official Title
-----------------
Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer

Conditions
-----------------
Colonic Neoplasms, Rectal Neoplasms

Intervention / Treatment
-----------------
* Behavioral: Aerobic exercise
* Behavioral: Progressive stretching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years Histologically confirmed stage I, II, or III colon or rectal cancer Completed surgical resection with curative intent Completed other cancer-directed treatments Engage in <150 minutes per week of moderate- to vigorous-intensity structured endurance exercise No planned major surgery during the study period Readiness to exercise, as determined by a modified version of the Physical Activity Readiness Questionnaire Ability to provide written informed consent Provide written approval by a qualified healthcare professional Willing to be randomized Exclusion Criteria: Evidence of metastatic or recurrent colorectal cancer Concurrently actively treated other (non-colorectal) cancer Scheduled to receive other postoperative cancer-directed treatment(s) Currently pregnant, breastfeeding, or planning to become pregnant within the next 24 weeks Currently participating in another study with competing outcomes Contraindications to magnetic resonance imaging Any dietary condition or restriction that would limit tolerance of a mixed meal challenge Any other cardiovascular, pulmonary, orthopedic, neurologic, psychiatric, or other condition that, in the investigator's opinion, would preclude participation or successful compliance with the protocol Any other situation that, in the opinion of the investigator, would negatively impact subject safety or successful compliance with the protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Attention control<br>Static stretching | Behavioral: Progressive stretching<br>* Statistic stretching of eight major muscle groups<br>|
| Experimental: Aerobic exercise<br>Aerobic exercise at a dose of 225 minutes per week | Behavioral: Aerobic exercise<br>* Moderate- to vigorous-intensity aerobic exercise<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole-Body Intermuscular Adipose Tissue | Mean (kg) whole-body intermuscular adipose tissue quantified using magnetic resonance imaging. | up to Week 12 |