Senior Adult Hepatobiliary Prehab Study

Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05921552
• Other study ID #: MCC-22153
• Status: Recruiting
• Phase: N/A
• Start date: June 14, 2023
• Est. completion date: September 2024

Study information

• Verified date: May 2024
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: Mohammed Al-Jumayli, MD
• Phone: 813-745-8658
• Email: Mohammed.AlJumayli[@]moffitt.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Hepatobiliary Cancer
• Liver Metastases

Intervention

Behavioral:
• Resistance Training
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
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

Locations

Country	Name	City	State
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   Moffitt Clinical Trial Search