Statewide Unified Network for Remote Intervention of Strength and Exercise (SUNRISE)

May 13, 2026 updated by: Justin Brown, AdventHealth Translational Research Institute

This study will evaluate whether a remotely delivered exercise program can improve chemotherapy tolerability in patients with gastrointestinal or lung cancer receiving chemotherapy.

In this decentralized, digital randomized clinical trial, up to 120 adults with gastrointestinal or lung cancer will be randomized to either a home-based aerobic and resistance exercise program or home-based progressive stretching program. All study activities will be conducted remotely using digital technologies and home-based assessments. Participants in both groups will receive Bluetooth-enabled wearable devices for monitoring physical activity, body weight, blood pressure, and other health measures.

The primary objective is to determine whether exercise improves chemotherapy relative dose intensity compared with stretching. The intervention will continue throughout chemotherapy treatment or for up to 32 weeks.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Gastrointestinal cancer (esophageal, gastric, pancreatic, colon, and rectal) treated with chemotherapy (and other treatments, as clinically indicated) before surgery OR Lung cancer (non-small cell and small-cell) treated with chemotherapy (and other treatments, as clinically indicated) for advanced- or extensive-stage disease.
  • Completion of the modified version of the Physical Activity Readiness Questionnaire.

Exclusion Criteria:

  • Actively treated for another non-gastrointestinal or non-lung malignancy (surveillance with observation is allowed).
  • Engage in more than 150 minutes per week of aerobic physical activity and two or more sessions of muscle strengthening activity per week over the last three months (self-report).
  • Unable to walk for 6 minutes or two city blocks independently (self-report).
  • Enrollment in another study that intervenes upon physical activity, diet, or body composition as a primary objective (self-report).
  • Unable to read and speak English.
  • No access to a reliable internet connection.
  • Currently an AdventHealth employee.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise
The exercise group will engage in aerobic and muscle-strengthening activities.
Behavioral: Exercise
The exercise group will be provided with Bluetooth-enabled devices and home exercise equipment. Participants will meet with an exercise trainer weekly to learn how to engage in the exercise program.
Active Comparator: Stretching
The stretching group will engage in whole-body static stretching activities.
Behavioral: Stretching
The stretching group will be provided with Bluetooth-enabled devices. Participants will meet with an exercise trainer weekly to learn how to engage in the stretching program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chemotherapy Relative Dose Intensity
Time Frame: Up to 32 weeks
The ratio of the delivered dose intensity to the standard or planned dose intensity.
Up to 32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth Translational Research Institute

Investigators

  • Principal Investigator: Justin Brown, Ph.D., Adventhealth

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

May 13, 2026

First Submitted That Met QC Criteria

May 13, 2026

First Posted (Actual)

May 19, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2376559

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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