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Aerobic Exercise for Colorectal Cancer (RESTORE Trial)

N/A
Recruiting
Led By Justin C. Brown, Ph.D.
Research Sponsored by Pennington Biomedical Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 12

Summary

This trial will study how exercise affects fat around the muscles of colorectal cancer survivors.

Who is the study for?
This trial is for adults over 18 who've had stage I, II, or III colon or rectal cancer and finished their surgery and other treatments. They should exercise less than 150 minutes a week and not be planning any major surgeries during the study. Participants must be ready to start exercising, have a doctor's approval, agree to random assignment in the trial, and give written consent.
What is being tested?
The study is looking at how regular aerobic exercise affects muscle changes in people who've survived colorectal cancer compared to those who just do stretching exercises. The main focus is on fat within muscles after completing cancer treatment.
What are the potential side effects?
Aerobic exercise may cause general discomfort like muscle soreness or fatigue initially as participants adjust to increased physical activity levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Whole-Body Intermuscular Adipose Tissue

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Aerobic exerciseExperimental Treatment1 Intervention
Aerobic exercise at a dose of 225 minutes per week
Group II: Attention controlPlacebo Group1 Intervention
Static stretching
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aerobic exercise
2000
Completed Phase 2
~1130

Find a Location

Who is running the clinical trial?

Pennington Biomedical Research CenterLead Sponsor
309 Previous Clinical Trials
180,062 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,927 Previous Clinical Trials
41,017,935 Total Patients Enrolled
Justin C. Brown, Ph.D.Principal InvestigatorPennington Biomedical Research Center
1 Previous Clinical Trials
219 Total Patients Enrolled
~41 spots leftby Mar 2027
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