Recruiting

Aerobic Exercise

Sponsor:

AdventHealth Translational Research Institute

Code:

NCT05789433

Conditions

Colonic Neoplasms

Rectal Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Aerobic exercise

Progressive stretching

Study Details

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.

Conditions

Colonic Neoplasms

Rectal Neoplasms

Study ID

NCT05789433

Start date

May 1, 2023

Status verified date

Jul, 2025

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

sham comparator: Attention control

Static stretching

experimental: Aerobic exercise

Aerobic exercise at a dose of 225 minutes per week

Interventions

Aerobic exercise

Moderate- to vigorous-intensity aerobic exercise

Progressive stretching

Statistic stretching of eight major muscle groups

Primary outcome measure

  • Whole-Body Intermuscular Adipose Tissue [ Time Frame: up to Week 12 ]

Central Contacts and Locations

Central contacts

Justin C. Brown, Ph.D.

407-303-5600Justin.Brown4@AdventHealth.com

Locations

AdventHealth

Recruiting

Orlando, Florida, United States, 32804

Contacts

Justin C Brown, Ph.D.

4073035600Justin.Brown4@AdventHealth.com

More Information

Sponsor

AdventHealth Translational Research Institute

Last update posted

Jul 3, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AdventHealth Translational Research Institute on 2025-07-03.