Senior Adult Hepatobiliary Prehab Study

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 65 years and older
• All sexes
• No healthy volunteers
• Older adult

Trial locations and contacts

1 site in 1 country.

About this study

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

Conditions

Hepatobiliary Cancer, Cholangiocarcinoma, Liver Metastases

Being tested

Resistance Training, Aerobic Training

Medical subject headings

Cholangiocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Resistance TrainingBehavioural

  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 TrainingBehavioural

  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

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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

   Measured: Up to 12 Months

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

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

   Measured: Up to 3 Months

3. 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

   Measured: Up to 3 Months

4. 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.

   Measured: Up to 3 Months

5. 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.

   Measured: Up to 3 Months

6. 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.

   Measured: Up to 3 Months

7. 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.

   Measured: At Baseline and Up to 3 Months

8. Participant Skeletal Muscle Index (SMI)

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

   Measured: At Baseline and Up to 3 Months

9. 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

   Measured: At Baseline and Up to 3 Months

10. 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.

    Measured: At Baseline and Up to 3 Months

11. 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)

    Measured: At Baseline and Up to 3 Months

12. 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

    Measured: At Baseline and Up to 3 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted27 Jun 2023
2. Study start26 Jun 2023
3. Primary completion19 Nov 2026 (estimated)
4. Study completion19 Nov 2026 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Hepatobiliary CancerStudies of the same condition, open and under way.
• More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.