Remote Resistance Exercise Powering Survivors

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

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-20

Study Completion Date

2026-08-22

Brief Summary

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The purpose of the study is to evaluate a tele-resistance training exercise program for individuals undergoing chemotherapy for advanced upper gastrointestinal cancer.

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Detailed Description

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Conditions

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Gastrointestinal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Usual Care (UC)

Participants randomized to the Usual Care (UC) arm will be provided with information materials outlining resistance training using body weight or basic equipment. Participants will wear a FitBit fitness watch to monitor aerobic exercise.

Group Type NO_INTERVENTION

No interventions assigned to this group

Tele-Resistance Training (RT)

Participants will be encouraged to perform approximately 30 minutes of resistance training exercises approximately twice per week for 12 weeks. Participants will also be encouraged to perform moderate aerobic exercise at least 3 times per week. Participants will wear a FitBit fitness watch to monitor aerobic exercise.

Group Type EXPERIMENTAL

Tele-Resistance Training

Intervention Type BEHAVIORAL

Tele-Resistance training sessions will be supervised and guided by a certified exercise trainer via smartphone, tablet or laptop. Exercises will be performed using resistance tubes (Bodylastics Resistance Bands Set) and a connectable bar (Bionic Body Workout Bar) that mimics a weighted barbell when tubes are attached. The tubes provide up to 142 pounds of resistance (adjustable in increments between 3-10 pounds) when simultaneously connected to handles or bar, and multiple tubes can be attached simultaneously. Participants will engage in brief warm up exercises lasting 2-3 minutes prior to each RT session and will rest at least 1 minute between sets of the same exercise to aid muscle recovery. Participants will perform at least 2 sets of 12 repetitions for each of 6 exercises. Including warm up, training sets, and rest, sessions will last approximately 30 minutes. RT will include six target exercises focusing on major muscle groups of the upper body, lower body, and core.

Interventions

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Tele-Resistance Training

Tele-Resistance training sessions will be supervised and guided by a certified exercise trainer via smartphone, tablet or laptop. Exercises will be performed using resistance tubes (Bodylastics Resistance Bands Set) and a connectable bar (Bionic Body Workout Bar) that mimics a weighted barbell when tubes are attached. The tubes provide up to 142 pounds of resistance (adjustable in increments between 3-10 pounds) when simultaneously connected to handles or bar, and multiple tubes can be attached simultaneously. Participants will engage in brief warm up exercises lasting 2-3 minutes prior to each RT session and will rest at least 1 minute between sets of the same exercise to aid muscle recovery. Participants will perform at least 2 sets of 12 repetitions for each of 6 exercises. Including warm up, training sets, and rest, sessions will last approximately 30 minutes. RT will include six target exercises focusing on major muscle groups of the upper body, lower body, and core.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Biopsy-proven upper GI cancer, stage III-IV
* ECOG performance status 0-1
* Treatment plan of chemotherapy with planned return to Moffitt Cancer Center for restaging
* Able to read and speak English fluently
* Capable of providing informed consent

Exclusion Criteria

* Regular engagement in RT (2x/week targeting all major muscle groups)
* Screen failure for exercise safety based on Physical Activity Readiness Questionnaire (PAR-Q) and Patient-Reported Measurement Information System (PROMIS) screening questions
* Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease (New York Heart Association functional class III or IV).
* Recent fracture or acute musculoskeletal injury that precludes ability to participate in RT
* Numeric pain rating scale of ≥ 7 out of 10
* Myopathic or rheumatologic disease that impacts physical function

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No