Home-based HIIT to Improve CRC Survivorship: Feasibility... | NCT04080414

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

NCT04080414

Sponsor

University of Utah

Status

Completed

Last Update Posted

Mar 22, 2023Actual

Enrollment

7Actual

Phase

Not Applicable

Conditions

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

Interventions

Home-based high-intensity interval training
Home-based moderate-intensity continuous exercise

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2, 2019Actual

Primary Completion Date

Feb 12, 2021Actual

Completion Date

Feb 12, 2021Actual

First Submitted Date

Aug 12, 2019

First Submission Date that Met QC Criteria

Sep 3, 2019

First Posted Date

Sep 6, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 20, 2023

Last Update Posted Date

Mar 22, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Home-based high-intensity interval training	Experimental		Behavioral: Home-based high-intensity interval training
Home-based moderate-intensity continuous exercise	Active Comparator		Behavioral: Home-based moderate-intensity continuous exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adriana M Coletta, PhD	University of Utah	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Intermountain Medical Center		Murray	Utah	84107	United States
Huntsman Cancer Institute at the University of Utah

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases

ID	Term
D015179	Colorectal Neoplasms
D003110	Colonic Neoplasms
D012004	Rectal Neoplasms