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Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer

Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05789433
Acronym
RESTORE
Enrollment
70
Registered
2023-03-29
Start date
2023-05-01
Completion date
2027-03-01
Last updated
2025-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Neoplasms, Rectal Neoplasms

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.

Interventions

BEHAVIORALAerobic exercise

Moderate- to vigorous-intensity aerobic exercise

Statistic stretching of eight major muscle groups

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
AdventHealth Translational Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Whole-Body Intermuscular Adipose Tissueup to Week 12Mean (kg) whole-body intermuscular adipose tissue quantified using magnetic resonance imaging.

Countries

United States

Contacts

Primary ContactJustin C. Brown, Ph.D.
Justin.Brown4@AdventHealth.com407-303-5600

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026