- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05789433
Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer (RESTORE)
June 5, 2024 updated by: Justin Brown, Pennington Biomedical Research Center
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Justin C. Brown, Ph.D.
- Phone Number: 225-763-2715
- Email: justin.brown@pbrc.edu
Study Locations
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70808
- Recruiting
- Pennington Biomedical Research Center
-
Contact:
- Justin C Brown, Ph.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Attention control
Static stretching
|
Statistic stretching of eight major muscle groups
|
Experimental: Aerobic exercise
Aerobic exercise at a dose of 225 minutes per week
|
Moderate- to vigorous-intensity aerobic exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Whole-Body Intermuscular Adipose Tissue
Time Frame: up to Week 12
|
Mean (kg) whole-body intermuscular adipose tissue quantified using magnetic resonance imaging.
|
up to Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Justin C. Brown, Ph.D., Pennington Biomedical Research Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2023
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Study Registration Dates
First Submitted
March 16, 2023
First Submitted That Met QC Criteria
March 28, 2023
First Posted (Actual)
March 29, 2023
Study Record Updates
Last Update Posted (Actual)
June 6, 2024
Last Update Submitted That Met QC Criteria
June 5, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PBRC 2022-014
- R01CA270274 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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