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Trial Title:
A Supervised Prehabilitation Program for Patients with Pancreatic Cancer
NCT ID:
NCT05692323
Condition:
Pancreas Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Conditions: Keywords:
Exercise
Prehabilitation
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:
Other
Intervention name:
PREHAB
Description:
6-week supervised PREHAB program. Each week of the program consists of 3 x 1 hour
supervised training sessions made up of moderate intensity aerobic training and
resistance training. In addition to the supervised sessions, patients will be instructed
to accumulate a total of 150 minutes per week of moderate aerobic training at home which
is measured by a wrist worn FitBit device.
Arm group label:
Supervised Prehabilitation Exercise Program
Summary:
The purpose of this study is to assess the use of an exercise program in people with
pancreatic cancer.
Detailed description:
Attendance to exercise sessions as well as impacts on healthcare utilization, muscle
mass, quality of life, physical activity, and post-operative outcomes when applicable
will be monitored.
Study participants will participant in a supervised, in-person exercise program 3 times
per week for 6 weeks. Participants will receive a Fitbit to be worn continuously during
the study and complete surveys and exercise tests at specified timepoints (Baseline,
Post-Intervention Evaluation and 3-Month Follow Up).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Pancreatic cancer diagnosis (any stage)
- Age ≥ 18 years
- Independent ambulation and activities of daily living (Discretion of referring/
treating oncologist)
- Godin-Shephard Leisure-Time Physical Activity Questionnaire score of ≤ 23
- Physically able to complete functional assessments including 6-minute walk test,
hand grip strength, short performance physical battery and performance metrics
- Answers no to all questions on PAR-Q OR is cleared to participate by their treating
oncologist
- Ability to read, write and understand English
- Written informed consent obtained from subject and ability for subjects to comply
with the requirements of the study
Inclusion criteria for remote monitoring of physical activity (Fitbit) and online Pain
portal only (failure to meet inclusion criterion below should not preclude subjects from
participating in main study):
- Access to a smart device capable of Fitbit syncing and accessing the online Pain
portal (www.painguide.com)
Exclusion Criteria:
- Has undergone or plans to undergo resection surgery prior to projected completion of
PREHAB exercise intervention
- Current pregnancy
Exclusion criteria for remote monitoring component of the study with Fitbit only (failure
to meet exclusion criterion below should not preclude the subject from participating in
main study):
- Using a pacemaker, implantable cardiac defibrillator, neurostimulator, cochlear
implants (removable hearing aids permitted), or other electronic medical equipment,
unless the PI deems study participation safe.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cedars-Sinai Medical Center
Address:
City:
Los Angeles
Zip:
90048
Country:
United States
Status:
Recruiting
Contact:
Last name:
Abrahm Levi
Phone:
310-248-8084
Email:
abrahm.levi@cshs.org
Contact backup:
Last name:
Arash Asher, MD
Contact backup:
Last name:
Andrew Hendifar, MD
Contact backup:
Last name:
Gillian Gresham, PhD
Contact backup:
Last name:
Alix Sleight Warner, PhD
Start date:
April 4, 2023
Completion date:
April 1, 2026
Lead sponsor:
Agency:
Cedars-Sinai Medical Center
Agency class:
Other
Source:
Cedars-Sinai Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05692323
