Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer

NCT ID: NCT05789433

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2027-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Colonic Neoplasms Rectal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Attention control

Static stretching

Group Type SHAM_COMPARATOR

Progressive stretching

Intervention Type BEHAVIORAL

Statistic stretching of eight major muscle groups

Aerobic exercise

Aerobic exercise at a dose of 225 minutes per week

Group Type EXPERIMENTAL

Aerobic exercise

Intervention Type BEHAVIORAL

Moderate- to vigorous-intensity aerobic exercise

Interventions

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Aerobic exercise

Moderate- to vigorous-intensity aerobic exercise

Intervention Type BEHAVIORAL

Progressive stretching

Statistic stretching of eight major muscle groups

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

AdventHealth Translational Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Justin Brown

Director, Exercise & Cancer Biology Research Program

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Justin C. Brown, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

AdventHealth

Locations

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AdventHealth

Orlando, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Justin C. Brown, Ph.D.

Role: CONTACT

407-303-5600

Facility Contacts

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Justin C Brown, Ph.D.

Role: primary

4073035600

Other Identifiers

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R01CA270274

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PBRC 2022-014

Identifier Type: -

Identifier Source: org_study_id

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