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Active, Not Recruiting

NCT Number: NCT05921552

Senior Adult Hepatobiliary Prehab Study

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Hepatobiliary Cancer Adenocarcinoma Carcinoma Cholangiocarcinoma Liver Metastases Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resistance training

Behavioral

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.

Aerobic training

Behavioral

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

Primary outcomes

  1. Percentage of Participants that Enroll and Consent - Enrollment Feasibility

    Time frame: Up to 12 Months

    Enrollment will be considered feasible if ≥60% of eligible and approached patients actually consent and enroll

  2. Percentage of Participants that Complete Study Assessments - Retention Feasibility

    Time frame: Up to 3 Months

    Retention will be considered feasible if ≥70% of participants complete study measures

  3. Adherence - Feasibility

    Time frame: 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

  4. Participant Self-Reported Musculoskeletal Injuries - Safety

    Time frame: 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.

  5. Exercise Training Safety

    Time frame: 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.

  6. Participant Evaluation of Feasibility and Acceptability - Acceptability

    Time frame: 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.

  7. Objective Physical Functioning and Fitness

    Time frame: 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.

  8. Participant Skeletal Muscle Index (SMI)

    Time frame: At Baseline and Up to 3 Months

    Participants SMI will be measured using Tomovision SliceOMatic software and clinical, computerized tomography (CT) scans

  9. Participants Health-Related Quality of Life

    Time frame: 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

  10. Patient Activation

    Time frame: 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.

  11. Social Support

    Time frame: 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)

  12. Participant Self Reported Exercise

    Time frame: 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

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2023
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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