Home-based HIIT to Improve CRC Survivorship: Feasibility and Relationship With Novel Surrogate Biomarkers of CRC Recurrence
Home-based High-intensity Interval Training to Improve Colorectal Cancer Survivorship: Feasibility and Relationship With Novel Surrogate Biomarkers of Colorectal Cancer Recurrence
1 other identifier
interventional
7
1 country
2
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable colorectal-cancer
Started Aug 2019
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 2, 2019
CompletedFirst Submitted
Initial submission to the registry
August 12, 2019
CompletedFirst Posted
Study publicly available on registry
September 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 12, 2021
CompletedMarch 22, 2023
March 1, 2023
1.5 years
August 12, 2019
March 20, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
12 weeks
Study Arms (2)
Home-based high-intensity interval training
EXPERIMENTALHome-based moderate-intensity continuous exercise
ACTIVE COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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).
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Intermountain Medical Center
Murray, Utah, 84107, United States
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, 84112, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adriana M Coletta, PhD
University of Utah
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 12, 2019
First Posted
September 6, 2019
Study Start
August 2, 2019
Primary Completion
February 12, 2021
Study Completion
February 12, 2021
Last Updated
March 22, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share