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

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.

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Key information

Conditions

Colorectal Cancer Colonic Cancer Colonic Diseases Colonic Neoplasms Colorectal Carcinoma Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Cancer Rectal Diseases Rectal Neoplasms

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Intermountain Medical Center, Murray, Utah, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home-based high-intensity interval training

Behavioral

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.

Home-based moderate-intensity continuous exercise

Behavioral

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 outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

Home-based High-intensity Interval Training to Improve Colorectal Cancer Survivorship: Feasibility and Relationship With Novel Surrogate Biomarkers of Colorectal Cancer Recurrence

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Sep 6, 2019
Registry last updated: Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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