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NCT Number: NCT05789433

Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AdventHealth

Orlando, Florida, 32804, United States

Location status: Recruiting

Location contact

Justin C Brown, Ph.D.

CONTACT

[email protected]

4073035600

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercise

Behavioral

Moderate- to vigorous-intensity aerobic exercise

Progressive Stretching

Behavioral

Statistic stretching of eight major muscle groups

Primary outcomes

  1. Whole-Body Intermuscular Adipose Tissue

    Time frame: up to Week 12

    Mean (kg) whole-body intermuscular adipose tissue quantified using magnetic resonance imaging.

Study contacts

Contact information is provided by the study sponsor or research team.

Justin C. Brown, Ph.D.

CONTACT

[email protected]

407-303-5600

Sponsors and collaborators

Lead sponsor

AdventHealth Translational Research Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Acronym: RESTORE

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 29, 2023
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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