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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05921552




Registration number
NCT05921552
Ethics application status
Date submitted
16/06/2023
Date registered
27/06/2023

Titles & IDs
Public title
Senior Adult Hepatobiliary Prehab Study
Scientific title
Feasibility of Exercise Prehabilitation Among Older Patients With Hepatobiliary Cancer Planning for Surgery
Secondary ID [1] 0 0
MCC-22153
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatobiliary Cancer 0 0
Cholangiocarcinoma 0 0
Liver Metastases 0 0
Condition category
Condition code
Cancer 0 0 0 0
Biliary tree (gall bladder and bile duct)
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Resistance Training
BEHAVIORAL - Aerobic Training

Experimental: Tele Health Exercise Prehabilitation - 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
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.

BEHAVIORAL: 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
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants that Enroll and Consent - Enrollment Feasibility
Timepoint [1] 0 0
Up to 12 Months
Primary outcome [2] 0 0
Percentage of Participants that Complete Study Assessments - Retention Feasibility
Timepoint [2] 0 0
Up to 3 Months
Primary outcome [3] 0 0
Adherence - Feasibility
Timepoint [3] 0 0
Up to 3 Months
Primary outcome [4] 0 0
Participant Self-Reported Musculoskeletal Injuries - Safety
Timepoint [4] 0 0
Up to 3 Months
Primary outcome [5] 0 0
Exercise Training Safety
Timepoint [5] 0 0
Up to 3 Months
Primary outcome [6] 0 0
Participant Evaluation of Feasibility and Acceptability - Acceptability
Timepoint [6] 0 0
Up to 3 Months
Primary outcome [7] 0 0
Objective Physical Functioning and Fitness
Timepoint [7] 0 0
At Baseline and Up to 3 Months
Primary outcome [8] 0 0
Participant Skeletal Muscle Index (SMI)
Timepoint [8] 0 0
At Baseline and Up to 3 Months
Primary outcome [9] 0 0
Participants Health-Related Quality of Life
Timepoint [9] 0 0
At Baseline and Up to 3 Months
Primary outcome [10] 0 0
Patient Activation
Timepoint [10] 0 0
At Baseline and Up to 3 Months
Primary outcome [11] 0 0
Social Support
Timepoint [11] 0 0
At Baseline and Up to 3 Months
Primary outcome [12] 0 0
Participant Self Reported Exercise
Timepoint [12] 0 0
At Baseline and Up to 3 Months

Eligibility
Key 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
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Does not meet inclusion criteria

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2024
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida

Funding & Sponsors
Primary sponsor type
Other
Name
H. Lee Moffitt Cancer Center and Research Institute
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mohammed Al-Jumayli, MD
Address 0 0
Moffitt Cancer Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Mohammed Al-Jumayli, MD
Address 0 0
Country 0 0
Phone 0 0
813-745-8658
Fax 0 0
Email 0 0
Mohammed.AlJumayli@moffitt.org
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05921552