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Trial Title:
Senior Adult Hepatobiliary Prehab Study
NCT ID:
NCT05921552
Condition:
Hepatobiliary Cancer
Cholangiocarcinoma
Liver Metastases
Conditions: Official terms:
Cholangiocarcinoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Resistance Training
Description:
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.
Arm group label:
Tele Health Exercise Prehabilitation
Intervention type:
Behavioral
Intervention name:
Aerobic Training
Description:
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
Arm group label:
Tele Health Exercise Prehabilitation
Summary:
The purpose of the study is to evaluate an exercise program for individuals with
hepatobiliary cancer planning for surgery.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
65 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Moffitt Cancer Center
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ashley Morganti
Phone:
813-745-1848
Email:
Ashley.Morganti@moffitt.org
Investigator:
Last name:
Mohammed Al-Jumayli, MD
Email:
Principal Investigator
Investigator:
Last name:
Nathan Parker, PhD, MPH
Email:
Sub-Investigator
Investigator:
Last name:
Daniel Anaya Saenz, MD
Email:
Sub-Investigator
Investigator:
Last name:
Kea Turner, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Martine Extermann, MD, PhD
Email:
Sub-Investigator
Start date:
June 14, 2023
Completion date:
July 2025
Lead sponsor:
Agency:
H. Lee Moffitt Cancer Center and Research Institute
Agency class:
Other
Source:
H. Lee Moffitt Cancer Center and Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05921552
https://www.moffitt.org/clinicaltrialssearch/?diseasesite=&query=22153&studytype=&medication=&therapy=&pi=&nct=&sortcriteria=
