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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04080414
• Other study ID #: 122238
• Status: Completed
• Phase: N/A
• Start date: August 2, 2019
• Est. completion date: February 12, 2021

Study information

• Verified date: March 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: February 12, 2021
• Est. primary completion date: February 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonic Cancer
• Colonic Neoplasms
• Colorectal Cancer
• Colorectal Carcinoma
• Colorectal Neoplasms
• Neoplasms
• Rectal Cancer
• Rectal Neoplasms
• Recurrence

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Intermountain Medical Center	Murray	Utah
United States	Huntsman Cancer Institute at the University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks