Senior Adult Hepatobiliary Prehab Study
- Conditions
- Hepatobiliary CancerLiver MetastasesCholangiocarcinoma
- Interventions
- Behavioral: Resistance TrainingBehavioral: Aerobic Training
- Registration Number
- NCT05921552
- Brief Summary
The purpose of the study is to evaluate an exercise program for individuals with hepatobiliary cancer planning for surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 25
- Age ≥65 years
- Resectable Hepatocellular carcinoma, Cholangiocarcinoma, or Liver metastasis with Liver resection planned ≥4 weeks
- ECOG 0-2
- Able to sign consent
- Does not meet inclusion criteria
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tele Health Exercise Prehabilitation Resistance Training 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. Tele Health Exercise Prehabilitation Aerobic Training 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants that Complete Study Assessments - Retention Feasibility Up to 3 Months Retention will be considered feasible if ≥70% of participants complete study measures
Participant Self-Reported Musculoskeletal Injuries - Safety Up to 3 Months 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.
Objective Physical Functioning and Fitness At Baseline and Up to 3 Months 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.
Percentage of Participants that Enroll and Consent - Enrollment Feasibility Up to 12 Months Enrollment will be considered feasible if ≥60% of eligible and approached patients actually consent and enroll
Adherence - Feasibility Up to 3 Months 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
Exercise Training Safety Up to 3 Months 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.
Participant Evaluation of Feasibility and Acceptability - Acceptability Up to 3 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.
Social Support At Baseline and Up to 3 Months 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)
Participant Self Reported Exercise At Baseline and Up to 3 Months Participant self-reported exercise will be measured using a modified Godin Leisure Time Exercise Questionnaire to assess both aerobic and resistance exercise
Participant Skeletal Muscle Index (SMI) At Baseline and Up to 3 Months Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans
Participants Health-Related Quality of Life At Baseline and Up to 3 Months Participants health-related quality of life will be measured using the 12-item Medical Outcomes Study Short Form Survey
Patient Activation At Baseline and Up to 3 Months 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States