Colorectal CancerNCT04080414
Home-based HIIT to Improve CRC Survivorship: Feasibility and Relationship With Novel Surrogate Biomarkers of CRC Recurrence
A study testing Home-based high-intensity interval training and Home-based moderate-intensity continuous exercise in people with Colorectal Cancer and Colorectal Neoplasms, run by University of Utah at 2 sites in United States.
Trial summary
This 12-week, exercise study will assess the feasibility of a home-based high-intensity interval training (HIIT) program among colorectal cancer survivors and explore the impact of home-based HIIT compared to a standard home-based moderate-intensity continuous aerobic exercise program on physical outcomes linked with… Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Colorectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma
- What is being tested?
- Home-based high-intensity interval training and Home-based moderate-intensity continuous exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Aug 2019to 12 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are no more than five years post resection and/or adjuvant therapy for stage II-III Colorectal cancer (CRC).
- Age 19-75 years old.
- Engaging in less than 90 minutes per week of structured moderate- or vigorous-intensity aerobic exercise in the past three months
- No known cardiovascular, metabolic or renal disease, and no signs/symptoms suggestive of cardiovascular, metabolic, or renal disease.
- Must be able to read, speak and understand English
- Willing to complete two assessment sessions (at baseline and 12 weeks).
Show all 9Show fewer
- Willing to engage in moderate- or vigorous-intensity aerobic exercise at home and use mobile health technology to track exercise adherence to the exercise prescription.
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
- Have regular access to a smart phone and willing to download a free application for device tracking
Who cannot join
- Functional limitations requiring a walker, scooter, or wheelchair.
- Clinically evident recurrent disease.
- Resting blood pressure ≥140/90 at the time of baseline testing.
- No access to smart phone and/or not willing download the device app
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Intermountain Medical Center
Murray, Utah, 84107
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: Home-based High-intensity Interval Training to Improve Colorectal Cancer Survivorship: Feasibility and Relationship With Novel Surrogate Biomarkers of Colorectal Cancer Recurrence
This 12-week, exercise study will assess the feasibility of a home-based high-intensity interval training (HIIT) program among colorectal cancer survivors and explore the impact of home-based HIIT compared to a standard home-based moderate-intensity continuous aerobic exercise program on physical outcomes linked with survival from colorectal cancer and surrogate blood markers of colorectal cancer recurrence.
HIIT is a type of aerobic exercise that includes short bursts (i.e. 1-4 minutes) of vigorous exercise followed by longer periods of moderate to lower intensity exercise (i.e. 1-10 minutes). Participants in this study will be randomly assigned into a personalized home based exercise program - either high-intensity interval training (HIIT) or moderate-intensity continuous aerobic exercise (MICE).
This pilot study will provide us with preliminary evidence for a larger trial aimed to compare the effectiveness of these two different types of home-based exercise programs on physical outcomes linked with survival, quality of life, and surrogate blood markers of colorectal cancer recurrence.
- Conditions
- Colorectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma, Colonic Neoplasms, Colonic Cancer, Rectal Neoplasms
- Being tested
- Home-based high-intensity interval training, Home-based moderate-intensity continuous exercise
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based high-intensity interval trainingBehavioural
Participants will be instructed to complete four, high-intensity interval training workouts per week at home, for the duration of the 12-week trial. Participants will be provided with detailed instructions on how to complete each workout.
Home-based moderate-intensity continuous exerciseBehavioural
Participants will be instructed to complete five, moderate-intensity continuous exercise workouts per week at home, for the duration of the 12-week trial. Participants will be provided with detailed instructions on how to complete each workout.
| Study group | Role | What they receive |
|---|---|---|
| Home-based high-intensity interval training | Experimental | Not described Receives: Behavioral: Home-based high-intensity interval training |
| Home-based moderate-intensity continuous exercise | Active comparator | Not described Receives: Behavioral: Home-based moderate-intensity continuous exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of home-based high-intensity interval training among colorectal cancer survivors
Feasibility will be assessed by adherence to the home-based high-intensity interval training protocol, which is defined at the participant level as completing ≥70% of workouts consistent with the exercise prescription. The intervention will be considered feasible if ≥75% of participants meet or exceed the 70% criterion.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start2 Aug 2019
- Primary completion12 Feb 2021
- Study completion12 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adriana Coletta, University of Utah
- Investigators
- Adriana M Coletta, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04080414
- Sponsor's protocol ID
- 122238
- Status last verified
- Mar 2023
- First submitted
- 12 Aug 2019
- Last updated
- 22 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based High-intensity Interval Training to Improve Colorectal Cancer Survivorship: Feasibility and Relationship With Novel Surrogate Biomarkers of Colorectal Cancer Recurrence
- ClinicalTrials.gov ID
- NCT04080414
- Acronym / sponsor ID
- 122238
- Conditions
- Colorectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma, Colonic Neoplasms, Colonic Cancer, Rectal Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 2 Aug 2019 (actual)
- Primary completion
- 12 Feb 2021 (actual)
- Study completion
- 12 Feb 2021 (actual)
- First posted
- 6 Sep 2019 (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.
This 12-week, exercise study will assess the feasibility of a home-based high-intensity interval training (HIIT) program among colorectal cancer survivors and explore the impact of home-based HIIT compared to a standard home-based moderate-intensity continuous aerobic exercise program on physical outcomes linked with survival from colorectal cancer and surrogate blood markers of colorectal cancer recurrence.
HIIT is a type of aerobic exercise that includes short bursts (i.e. 1-4 minutes) of vigorous exercise followed by longer periods of moderate to lower intensity exercise (i.e. 1-10 minutes). Participants in this study will be randomly assigned into a personalized home based exercise program - either high-intensity interval training (HIIT) or moderate-intensity continuous aerobic exercise (MICE).
This pilot study will provide us with preliminary evidence for a larger trial aimed to compare the effectiveness of these two different types of home-based exercise programs on physical outcomes linked with survival, quality of life, and surrogate blood markers of colorectal cancer recurrence.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based high-intensity interval training | Experimental | Behavioral: Home-based high-intensity interval training |
| Home-based moderate-intensity continuous exercise | Active comparator | Behavioral: Home-based moderate-intensity continuous exercise |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who are no more than five years post resection and/or adjuvant therapy for stage II-III Colorectal cancer (CRC).
- Age 19-75 years old.
- Engaging in less than 90 minutes per week of structured moderate- or vigorous-intensity aerobic exercise in the past three months
- No known cardiovascular, metabolic or renal disease, and no signs/symptoms suggestive of cardiovascular, metabolic, or renal disease.
- Must be able to read, speak and understand English
Key exclusion criteria (4 listed)
- Functional limitations requiring a walker, scooter, or wheelchair.
- Clinically evident recurrent disease.
- Resting blood pressure ≥140/90 at the time of baseline testing.
- No access to smart phone and/or not willing download the device app
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 |
|---|---|---|
| Home-based high-intensity interval trainingParticipants will be instructed to complete four, high-intensity interval training workouts per week at home, for the duration of the 12-week trial. Participants will be provided with detailed instructions on how to complete each workout. | Behavioural | Home-based high-intensity interval training |
| Home-based moderate-intensity continuous exerciseParticipants will be instructed to complete five, moderate-intensity continuous exercise workouts per week at home, for the duration of the 12-week trial. Participants will be provided with detailed instructions on how to complete each workout. | Behavioural | Home-based moderate-intensity continuous exercise |
Primary outcome
Feasibility of home-based high-intensity interval training among colorectal cancer survivors
Time frame: 12 weeks
Feasibility will be assessed by adherence to the home-based high-intensity interval training protocol, which is defined at the participant level as completing ≥70% of workouts consistent with the exercise prescription. The intervention will be considered feasible if ≥75% of participants meet or exceed the 70% criterion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Adriana M Coletta, PhD principal investigator
University of Utah
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based high-intensity interval training and Home-based moderate-intensity continuous exercise in people with Colorectal Cancer and Colorectal Neoplasms, run by University of Utah at 2 sites 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 9 inclusion and 4 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: finished, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of home-based high-intensity interval training among colorectal cancer survivors (time frame: 12 weeks). 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 22 Mar 2023.