Home-based HIIT to Improve CRC Survivorship: Feasibility and Relationship With Novel Surrogate Biomarkers of CRC Recurrence

• Sponsor: University of Utah (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04080414
• Collaborator: (none)
• Enrollment: 30
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 36
• Patients Per Site: 15
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer; Colorectal Neoplasms; Colorectal Carcinoma; Colonic Neoplasms; Colonic Cancer; Rectal Neoplasms; Rectal Cancer	Behavioral: Home-based high-intensity interval training; Behavioral: Home-based moderate-intensity continuous exercise	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Home-based High-intensity Interval Training to Improve Colorectal Cancer Survivorship: Feasibility and Relationship With Novel Surrogate Biomarkers of Colorectal Cancer Recurrence
• Actual Study Start Date: Aug 2, 2019
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Home-based high-intensity interval training	Behavioral: Home-based high-intensity interval training; 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.
Active Comparator: Home-based moderate-intensity continuous exercise	Behavioral: Home-based moderate-intensity continuous exercise; 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.

Outcome Measures

Primary Outcome Measures

1. Feasibility of home-based high-intensity interval training among colorectal cancer survivors [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients who are no more than five years post resection and/or adjuvant therapy for stage II-III Colorectal cancer (CRC).

2. Age 19-75 years old.

3. Engaging in less than 90 minutes per week of structured moderate- or vigorous-intensity aerobic exercise in the past three months

4. No known cardiovascular, metabolic or renal disease, and no signs/symptoms suggestive of cardiovascular, metabolic, or renal disease.

5. Must be able to read, speak and understand English

6. Willing to complete two assessment sessions (at baseline and 12 weeks).

7. 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.

8. Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

9. Have regular access to a smart phone and willing to download a free application for device tracking

Exclusion Criteria:

1. Functional limitations requiring a walker, scooter, or wheelchair.

2. Clinically evident recurrent disease.

3. Resting blood pressure ≥140/90 at the time of baseline testing.

4. No access to smart phone and/or not willing download the device app

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Intermountain Medical Center	Murray	Utah	United States	84107
2	Huntsman Cancer Institute at the University of Utah	Salt Lake City	Utah	United States	84112

Sponsors and Collaborators

• University of Utah

Investigators

• Principal Investigator: Adriana M Coletta, PhD, University of Utah

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Adriana Coletta, Assistant Professor, University of Utah
• ClinicalTrials.gov Identifier: NCT04080414
• Other Study ID Numbers: 122238
• First Posted: Sep 6, 2019
• Last Update Posted: Oct 5, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms; Colorectal Neoplasms; Rectal Neoplasms; Colonic Neoplasms; Recurrence

Study Results

No Results Posted as of Oct 5, 2021