Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer

Not Applicable

Recruiting

• Conditions: Rectal Neoplasms; Colonic Neoplasms
• Interventions: Behavioral: Progressive stretching; Behavioral: Aerobic exercise

• Registration Number: NCT05789433
• Lead Sponsor: Pennington Biomedical Research Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-16
• Study First Submitted QC: 2023-03-28
• Study First Posted: 2023-03-29
• Study Start: 2023-05-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-06
• Primary Completion: 2027-03
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Attention control	Progressive stretching	Static stretching
Aerobic exercise	Aerobic exercise	Aerobic exercise at a dose of 225 minutes per week

Primary Outcome Measures

Name	Time	Method
Whole-Body Intermuscular Adipose Tissue	up to Week 12	Mean (kg) whole-body intermuscular adipose tissue quantified using magnetic resonance imaging.

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States