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

Not Applicable

Completed

• Conditions: Colorectal Cancer; Rectal Neoplasms; Colorectal Carcinoma; Rectal Cancer; Colorectal Neoplasms; Colonic Neoplasms; Colonic Cancer
• Interventions: Behavioral: Home-based moderate-intensity continuous exercise; Behavioral: Home-based high-intensity interval training

• Registration Number: NCT04080414
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-02
• Study First Submitted: 2019-08-12
• Study First Submitted QC: 2019-09-03
• Study First Posted: 2019-09-06
• Primary Completion: 2021-02-12
• Study Completion: 2021-02-12
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-20
• Last Update Posted: 2023-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home-based moderate-intensity continuous exercise	Home-based moderate-intensity continuous exercise	-
Home-based high-intensity interval training	Home-based high-intensity interval training	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States

Huntsman Cancer Institute at the University of Utah; 🇺🇸 Salt Lake City, Utah, United States