Back to resultsHome-based HIIT to Improve CRC Survivorship: Feasibility and Relationship With Novel Surrogate Biomarkers of CRC Recurrence
Primary Purpose
Colorectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Home-based high-intensity interval training
Home-based moderate-intensity continuous exercise
Sponsored by
About this trial
This is an interventional other trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Intermountain Medical Center
- Huntsman Cancer Institute at the University of Utah
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Home-based high-intensity interval training
Home-based moderate-intensity continuous exercise
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04080414
Brief Title
Home-based HIIT to Improve CRC Survivorship: Feasibility and Relationship With Novel Surrogate Biomarkers of CRC Recurrence
Official Title
Home-based High-intensity Interval Training to Improve Colorectal Cancer Survivorship: Feasibility and Relationship With Novel Surrogate Biomarkers of Colorectal Cancer Recurrence
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
August 2, 2019 (Actual)
Primary Completion Date
February 12, 2021 (Actual)
Study Completion Date
February 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Colorectal Neoplasms, Colorectal Carcinoma, Colonic Neoplasms, Colonic Cancer, Rectal Neoplasms, Rectal Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Home-based high-intensity interval training
Arm Type
Experimental
Arm Title
Home-based moderate-intensity continuous exercise
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Home-based high-intensity interval training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Home-based moderate-intensity continuous exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of home-based high-intensity interval training among colorectal cancer survivors
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriana M Coletta, PhD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Huntsman Cancer Institute at the University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Home-based HIIT to Improve CRC Survivorship: Feasibility and Relationship With Novel Surrogate Biomarkers of CRC Recurrence
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