Senior Adult Hepatobiliary Prehab Study

Study Overview
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Brief Summary
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The purpose of the study is to evaluate an exercise program for individuals with hepatobiliary cancer planning for surgery.

Official Title
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Feasibility of Exercise Prehabilitation Among Older Patients With Hepatobiliary Cancer Planning for Surgery

Conditions
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Hepatobiliary Cancer, Cholangiocarcinoma, Liver Metastases

Intervention / Treatment
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* Behavioral: Resistance Training
* Behavioral: Aerobic Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥65 years Resectable Hepatocellular carcinoma, Cholangiocarcinoma, or Liver metastasis with Liver resection planned ≥4 weeks ECOG 0-2 Able to sign consent Exclusion Criteria: Does not meet inclusion criteria

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tele Health Exercise Prehabilitation<br>Participants will take part in an exercise program in which they will be encouraged to perform approximately 30 minutes of resistance training exercises approximately twice per week until they undergo surgery (Approximately 2-4 weeks). Participants will also be encouraged to perform moderate aerobic exercise such as brisk walking or using stationary aerobic equipment at least 3 times per week. Participants will wear a FitBit fitness watch to monitor aerobic exercise. | Behavioral: Resistance Training<br>* 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.<br>Behavioral: Aerobic Training<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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 | 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 | 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. | 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) | 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 | At Baseline and Up to 3 Months |