The purpose of the study is to evaluate an exercise program for individuals with hepatobiliary cancer planning for surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
25
Participants will be encouraged to perform approximately 30 minutes of resistance training exercises twice per week, until they undergo surgery. Exercises will be performed using resistance tubes (Bodylastics Inc) and the included accessories (handles and anchor straps) to perform resistance exercises. During Zoom sessions, certified exercise trainers will guide participants to utilize equipment to perform resistance exercises with proper form. Each groups resistance training session will span approximately 1 hour, including a brief warm-up, stretching, and 2 sets of ≥12 repetitions for each of 5 exercises: single arm chest press, single arm row, lateral raise, squat (or chair stand), and resistance tube deadlift.
Participants will be encouraged to perform ≥30 minutes of moderate-intensity aerobic exercise on ≥3 days per week. Aerobic exercise intensity will be guided by heart rate zones, with participants exercising at 50-70% of their age-predicted maximum heart rate in bouts of at least 10 minutes at a time. Participants will be encouraged to gradually increase exercise intensity and duration until they are meeting the recommendation
Moffitt Cancer Center
Tampa, Florida, United States
Percentage of Participants that Enroll and Consent - Enrollment Feasibility
Enrollment will be considered feasible if ≥60% of eligible and approached patients actually consent and enroll
Time frame: Up to 12 Months
Percentage of Participants that Complete Study Assessments - Retention Feasibility
Retention will be considered feasible if ≥70% of participants complete study measures
Time frame: Up to 3 Months
Adherence - Feasibility
Adherence will be based on participants attending ≥ 70% of tele-RT sessions on average and performing ≥ 70% of prescribed moderate-intensity aerobic exercise per week
Time frame: Up to 3 Months
Participant Self-Reported Musculoskeletal Injuries - Safety
The numerator of the safety variable will be the number of musculoskeletal injuries or adverse health events reported as "likely related" or "definitely related" the exercise programming and that caused at least some limitation of daily activity lasting more than 3 days. The denominator for the safety variable will be the number of exercise training sessions attended by the participant.
Time frame: Up to 3 Months
Exercise Training Safety
Number of participants that reported any exercise-related musculoskeletal injuries or other adverse health events (e.g.,extreme fatigue, shortness of breath, heat-related illness, cardiovascular events, changes in medication) incurred over the course of the intervention.
Time frame: Up to 3 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.
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Time frame: Up to 3 Months
Objective Physical Functioning and Fitness
Physical functioning and fitness will be assessed using the 30-second chair stand test,30-second arm curl test, and treadmill 6-minute walk test.
Time frame: At Baseline and Up to 3 Months
Participant Skeletal Muscle Index (SMI)
Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans
Time frame: At Baseline and Up to 3 Months
Participants Health-Related Quality of Life
Participants health-related quality of life will be measured using the 12-item Medical Outcomes Study Short Form Survey
Time frame: At Baseline and Up to 3 Months
Patient Activation
Participants patient activation will be measured using the Patient Activation Measure Short Form that is a valid and reliable 13-item scale for measuring patient's self-reported knowledge, skill, and confidence for self-management.
Time frame: At Baseline and Up to 3 Months
Social Support
Participants social support will be measured using two scales, the Multidimensional Scale of Perceived Social Support (a valid 12-item measure assessing perceived adequacy of general social support from friends, family, and significant others) and the Social Influence Scale for Exercise (positive influences) (a valid 15-item measure assessing perceived adequacy of exerciserelated social support from friends, family, and experts)
Time frame: At Baseline and Up to 3 Months
Participant Self Reported Exercise
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 and Up to 3 Months