Colonic NeoplasmsRESTORENCT05789433
Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer
A study testing Aerobic exercise and Progressive stretching in people with Colonic Neoplasms and Rectal Neoplasms, run by AdventHealth Translational Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Neoplasms, Rectal Neoplasms
- What is being tested?
- Aerobic exercise and Progressive stretching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
AdventHealth
Orlando, Florida, 32804
Justin C Brown, Ph.D., 4073035600, Justin.Brown4@AdventHealth.com
About this study
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
- Being tested
- Aerobic exercise, Progressive stretching
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseBehavioural
Moderate- to vigorous-intensity aerobic exercise
Progressive stretchingBehavioural
Statistic stretching of eight major muscle groups
| Study group | Role | What they receive |
|---|---|---|
| Attention control | Sham comparator | Static stretching Receives: Behavioral: Progressive stretching |
| Aerobic exercise | Experimental | Aerobic exercise at a dose of 225 minutes per week Receives: Behavioral: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-Body Intermuscular Adipose Tissue
Mean (kg) whole-body intermuscular adipose tissue quantified using magnetic resonance imaging.
Measured: up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start1 May 2023
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AdventHealth Translational Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Justin Brown, AdventHealth Translational Research Institute
- Investigators
- Justin C. Brown, Ph.D., Principal investigator, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05789433
- Sponsor's protocol ID
- PBRC 2022-014
- Other IDs
- R01CA270274
- Acronym
- RESTORE
- Status last verified
- Jul 2025
- First submitted
- 16 Mar 2023
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Exercise on Skeletal Muscle Remodeling in Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05789433
- Acronym / sponsor ID
- RESTORE / PBRC 2022-014
- Conditions
- Colonic Neoplasms, Rectal Neoplasms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- AdventHealth Translational Research InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 29 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attention control | Sham comparator | Behavioral: Progressive stretchingStatic stretching |
| Aerobic exercise | Experimental | Behavioral: Aerobic exerciseAerobic exercise at a dose of 225 minutes per week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exerciseModerate- to vigorous-intensity aerobic exercise | Behavioural | Aerobic exercise |
| Progressive stretchingStatistic stretching of eight major muscle groups | Behavioural | Attention control |
Primary outcome
Whole-Body Intermuscular Adipose Tissue
Time frame: up to Week 12
Mean (kg) whole-body intermuscular adipose tissue quantified using magnetic resonance imaging.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Justin C. Brown, Ph.D. principal investigator
AdventHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise and Progressive stretching in people with Colonic Neoplasms and Rectal Neoplasms, run by AdventHealth Translational Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Justin C. Brown, Ph.D. (407-303-5600, Justin.Brown4@AdventHealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole-Body Intermuscular Adipose Tissue (time frame: up to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.