The purpose of the study is to evaluate a tele-resistance training exercise program for individuals undergoing chemotherapy for advanced upper gastrointestinal cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
100
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.
Moffitt Cancer Center
Tampa, Florida, United States
RECRUITINGPercentage of Participants that Enroll and Consent - Enrollment Feasibility
Enrollment will be considered feasible if ≥ 70% of eligible and approached patients actually consent and enroll
Time frame: Up to 36 Months
Percentage of Participants that Complete Study Assessments - Retention Feasibility
Retention will be considered feasible if ≥ 70% of participants who complete baseline measures also complete followup measures
Time frame: Up to 3 Months
Exercise Adherence - Feasibility
Exercise adherence will be assessed based on performance of prescribed exercise volume, with tele-RT volumes considered feasible if participants perform ≥ 70% of the volume prescribed.
Time frame: Up to 6 Months
Participant Evaluation of Feasibility and Acceptability - Acceptability
Participants evaluation of feasibility and acceptability will be assessed with a questionnaire, adapted to fit the intervention. The questionnaire includes both Likert Scale and open-ended questions. An item-by-item basis and as average item score, with scores ≥4 ("agree" to "strongly agree") indicating acceptability. Open-ended responses will be analyzed qualitatively to inform intervention improvement.
Time frame: Up to 6 Months
Participant Self-Reported Musculoskeletal Injuries - Safety
Participants will be asked to report the following information: type (joint or soft tissue or other), location (specific body part), and cause (description of activity during which injury was incurred). Participants will then rate the injury on a scale of 1-4 (1=not related, 2=unlikely related, 3=likely related, 4=definitely related). The severity of the injury will be rated on a scale of 1-4 (1=mild/no change in daily activity, 2=some limitation of daily activity, 3=major limitation of daily activity, 4=life threatening). The duration for which daily activities were impacted will be rated on a scale from 1-5 (1=no change, 2=1-3 days, 3=4-7 days, 4=1-2 weeks, 5=more than 2 weeks). The numerator of the variable used to determine program safety will be the number of musculoskeletal injuries that were rated at least a 3 for relatedness to RT (likely related or definitely related) and caused at least some limitation of daily activity lasting more than 3 days.
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Time frame: Up to 6 Months
Participant Muscular Strength - Baseline
Muscular strength will be measured using four separate 1-repetition maximum (1RM) lifts: chest press, seated row, leg press, and leg extension performed on resistance training machines. If a particular 1RM lift is contraindicated for a given participant (e.g., limited range of motion for a given joint or osteoporosis), the lift will be skipped, or 5-repetition maximum (5RM) will be measured instead of 1RM, and 1RM will be estimated from 5RM.
Time frame: At Baseline
Participant Muscular Strength - Follow-up
Muscular strength will be measured using four separate 1-repetition maximum (1RM) lifts: chest press, seated row, leg press, and leg extension performed on resistance training machines. If a particular 1RM lift is contraindicated for a given participant (e.g., limited range of motion for a given joint or osteoporosis), the lift will be skipped, or 5-repetition maximum (5RM) will be measured instead of 1RM, and 1RM will be estimated from 5RM.
Time frame: Up to 6 Months
Participant Muscular Endurance - Baseline
Muscular endurance will be measured by the maximum number of repetitions a participant can perform at 70% of the baseline 1-repetition maximum (1RM) for the same four lifts
Time frame: At Baseline
Participant Muscular Endurance - Follow-up
Muscular endurance will be measured by the maximum number of repetitions a participant can perform at 70% of the baseline 1-repetition maximum (1RM) for the same four lifts
Time frame: Up to 6 Months
Participant Skeletal Muscle Index (SMI) - Baseline
Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans from baseline to follow up.
Time frame: At Baseline
Participant Skeletal Muscle Index (SMI) - Follow-up
Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans from baseline to follow up.
Time frame: Up to 6 Months
Participant Skeletal Muscle Density (SMD) - Baseline
Participants SMD will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans from baseline to follow up.
Time frame: At Baseline
Participant Skeletal Muscle Density (SMD) - Follow-up
Participants SMD will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans from baseline to follow up.
Time frame: Up to 6 Months
Participants Health-Related Quality of Life
Health-related quality of life will be measured using the Functional Assessment of Cancer Therapy-General (FACT-G)
Time frame: Up to 6 Months
Participant Fatigue
Participant fatigue will be measured using the FACT-Fatigue questionnaire (FACT-F)
Time frame: Up to 6 Months
Participant Physical Functioning
Participants physical functioning will be measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Short Form
Time frame: Up to 6 Months
Participant Chemotherapy-induced peripheral neuropathy (CIPN)
Participant CIPN will be measured using the European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-CIPN twenty-item scale (QLQ-CIPN20)
Time frame: Up to 6 Months
Participant Self Reported Exercise - Baseline
Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise
Time frame: At Baseline
Participant Self Reported Exercise - Follow-up
Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise
Time frame: Up to 6 Months
Participant Clinicodemographic Characteristics - Baseline
Participant clinicodemographic characteristics including tumor type and cancer stage, chemotherapy type, sex, age, body mass index, race/ethnicity, and marital status will be collected from participants' electronic medical records.
Time frame: At Baseline
Participant Clinicodemographic Characteristics - Follow-up
Participant clinicodemographic characteristics including tumor type and cancer stage, chemotherapy type, sex, age, body mass index, race/ethnicity, and marital status will be collected from participants' electronic medical records.
Time frame: Up to 6 Months
Participant Treatment Outcome
Participant relevant treatment outcomes including chemotherapy dose reductions and changes in chemotherapy will be collected from participants' electronic medical records.
Time frame: Up to 6 Months