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

NCT ID: NCT04080414

Last Updated: 2023-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-02

Study Completion Date

2021-02-12

Brief Summary

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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

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Conditions

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Colorectal Cancer Colorectal Neoplasms Colorectal Carcinoma Colonic Neoplasms Colonic Cancer Rectal Neoplasms Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Home-based high-intensity interval training

Group Type EXPERIMENTAL

Home-based high-intensity interval training

Intervention Type 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

Group Type ACTIVE_COMPARATOR

Home-based moderate-intensity continuous exercise

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Adriana Coletta

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adriana M Coletta, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

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Intermountain Medical Center

Murray, Utah, United States

Site Status

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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122238

Identifier Type: -

Identifier Source: org_study_id

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