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Trial Title:
Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer
NCT ID:
NCT05789433
Condition:
Colonic Neoplasms
Rectal Neoplasms
Conditions: Official terms:
Neoplasms
Rectal Neoplasms
Colonic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Double (Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Aerobic exercise
Description:
Moderate- to vigorous-intensity aerobic exercise
Arm group label:
Aerobic exercise
Intervention type:
Behavioral
Intervention name:
Progressive stretching
Description:
Statistic stretching of eight major muscle groups
Arm group label:
Attention control
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Pennington Biomedical Research Center
Address:
City:
Baton Rouge
Zip:
70808
Country:
United States
Status:
Recruiting
Contact:
Last name:
Justin C Brown, Ph.D.
Start date:
May 1, 2023
Completion date:
March 2027
Lead sponsor:
Agency:
Pennington Biomedical Research Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Pennington Biomedical Research Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05789433
