Statewide Unified Network for Remote Intervention of Strength and Exercise

Sponsor
AdventHealth Translational Research Institute
Study ID
NCT07596732
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Exercise — BEHAVIORAL
    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.
  • Stretching — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
May 19, 2026
Start date
Jul 1, 2026
Status verified
May 2026
Primary completion
Aug 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Exercise
    The exercise group will engage in aerobic and muscle-strengthening activities.
  • Active Comparator: Stretching
    The stretching group will engage in whole-body static stretching activities.

Primary Outcome Measure

Chemotherapy Relative Dose Intensity [ Time Frame: Up to 32 weeks ]

Central Contacts

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