Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer
RESTORE
2 other identifiers
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2023
CompletedFirst Posted
Study publicly available on registry
March 29, 2023
CompletedStudy Start
First participant enrolled
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
July 3, 2025
July 1, 2025
3.8 years
March 16, 2023
July 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Whole-Body Intermuscular Adipose Tissue
Mean (kg) whole-body intermuscular adipose tissue quantified using magnetic resonance imaging.
up to Week 12
Study Arms (2)
Attention control
SHAM COMPARATORStatic stretching
Aerobic exercise
EXPERIMENTALAerobic exercise at a dose of 225 minutes per week
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AdventHealth
Orlando, Florida, 32804, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Justin C. Brown, Ph.D.
AdventHealth
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Exercise & Cancer Biology Research Program
Study Record Dates
First Submitted
March 16, 2023
First Posted
March 29, 2023
Study Start
May 1, 2023
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
July 3, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share