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

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Colorectal Carcinoma; Colonic Neoplasms; Colonic Cancer; Colorectal Neoplasms; Rectal Neoplasms; Rectal Cancer; Colorectal Cancer

Treatments: Behavioral: Home-based moderate-intensity continuous exercise; Behavioral: Home-based high-intensity interval training

Study type: Interventional

Funder types: Other

Identifiers

NCT04080414

122238

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

Home-based high-intensity interval training

Experimental group

Treatment:

Behavioral: Home-based high-intensity interval training

Home-based moderate-intensity continuous exercise

Active Comparator group

Treatment:

Behavioral: Home-based moderate-intensity continuous exercise