Remote Resistance Exercise Powering Survivors - Gastrointestinal Oncology
- Conditions
- Gastrointestinal Cancer
- Interventions
- Behavioral: Tele-Resistance Training
- Registration Number
- NCT05664178
- Brief Summary
The purpose of the study is to evaluate a tele-resistance training exercise program for individuals undergoing chemotherapy for advanced upper gastrointestinal cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tele-Resistance Training (RT) Tele-Resistance Training 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants that Enroll and Consent - Enrollment Feasibility Up to 36 Months Enrollment will be considered feasible if ≥ 70% of eligible and approached patients actually consent and enroll
Participant Muscular Strength - Baseline At 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.
Participant Clinicodemographic Characteristics - Follow-up Up to 6 Months 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.
Exercise Adherence - Feasibility Up to 6 Months 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.
Participant Self-Reported Musculoskeletal Injuries - Safety Up to 6 Months 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.
Participant Muscular Endurance - Follow-up Up to 6 Months 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
Participant Skeletal Muscle Index (SMI) - Baseline At Baseline Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans from baseline to follow up.
Participant Skeletal Muscle Index (SMI) - Follow-up Up to 6 Months Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans from baseline to follow up.
Participant Skeletal Muscle Density (SMD) - Follow-up Up to 6 Months Participants SMD will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans from baseline to follow up.
Participant Muscular Strength - Follow-up Up to 6 Months 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.
Participant Self Reported Exercise - Baseline At Baseline Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise
Participant Self Reported Exercise - Follow-up Up to 6 Months Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise
Participant Treatment Outcome Up to 6 Months Participant relevant treatment outcomes including chemotherapy dose reductions and changes in chemotherapy will be collected from participants' electronic medical records.
Percentage of Participants that Complete Study Assessments - Retention Feasibility Up to 3 Months Retention will be considered feasible if ≥ 70% of participants who complete baseline measures also complete followup measures
Participant Skeletal Muscle Density (SMD) - Baseline At Baseline Participants SMD will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans from baseline to follow up.
Participants Health-Related Quality of Life Up to 6 Months Health-related quality of life will be measured using the Functional Assessment of Cancer Therapy-General (FACT-G)
Participant Fatigue Up to 6 Months Participant fatigue will be measured using the FACT-Fatigue questionnaire (FACT-F)
Participant Chemotherapy-induced peripheral neuropathy (CIPN) Up to 6 Months 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)
Participant Evaluation of Feasibility and Acceptability - Acceptability Up to 6 Months 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.
Participant Muscular Endurance - Baseline At 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
Participant Physical Functioning Up to 6 Months Participants physical functioning will be measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Functioning Short Form
Participant Clinicodemographic Characteristics - Baseline At 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States