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Recruiting NCT05789433

Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer

No phase Interventional Colonic Neoplasms Rectal Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aerobic exercise, Progressive stretching.
Who it may be relevant to
Registry conditions: Colonic Neoplasms, Rectal Neoplasms. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral Aerobic exercise
    Moderate- to vigorous-intensity aerobic exercise
  • Behavioral Progressive stretching
    Statistic stretching of eight major muscle groups

Primary outcome measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • AdventHealth — Orlando

Identifiers

NCT: NCT05789433 · PBRC 2022-014 · R01CA270274

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗