Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer (RESTORE)

July 1, 2025 updated by: Justin Brown, AdventHealth Translational Research Institute
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

Study Locations

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
Behavioral: Progressive stretching
Statistic stretching of eight major muscle groups
Experimental: Aerobic exercise
Aerobic exercise at a dose of 225 minutes per week
Behavioral: Aerobic exercise
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.

Sponsor

AdventHealth Translational Research Institute

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Justin C. Brown, Ph.D., AdventHealth

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)

July 3, 2025

Last Update Submitted That Met QC Criteria

July 1, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBRC 2022-014
  • R01CA270274 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

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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