Senior Adult Hepatobiliary Prehab Study

NCT05921552 | Active Not Recruiting

• 1 other identifier: MCC-22153
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatobiliary Cancer; Cholangiocarcinoma; Liver Metastases

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (1)

Tele Health Exercise Prehabilitation

EXPERIMENTAL

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; Behavioral: Aerobic Training

Interventions

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.

Tele Health Exercise Prehabilitation

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

Tele Health Exercise Prehabilitation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥65 years
• Resectable Hepatocellular carcinoma, Cholangiocarcinoma, or Liver metastasis with Liver resection planned ≥4 weeks
• ECOG 0-2
• Able to sign consent

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Clinical Trial Search

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mohammed Al-Jumayli, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: June 27, 2023
• Study Start: June 26, 2023
• Primary Completion (Estimated): November 19, 2026
• Study Completion (Estimated): November 19, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)