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Trial Title:
Feasibility of a Health Care Provider Guided Exercise Intervention Prior to Surgical Resection of Pancreatic Cancer
NCT ID:
NCT05483075
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Conditions: Keywords:
HCP-Guided Exercise
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
HCP-Guided Exercise Training Program
Description:
Individually tailored exercise program consisting of aerobic training (5 days per week
for a minimum of 30 minutes at moderate intensity) and strength training (2 days per week
at moderate intensity).
Two days per week the participant will receive their exercise program at NYU Langone
Health. When at NYU, the training will be supervised by a physical therapist and will
consist of the following: warm-up of 5 minutes, 30 minutes of aerobic exercise on either
a stationary bike or treadmill at 60-70% of maximum heart rate. Following aerobic
training, strength training will be carried out. Strength training will consist of 1
exercise per major muscle group, 8-12 reps, 1-3 sets at moderate intensity.
The remaining three days a week the participant will perform aerobic training at home by
exercising on a bicycle or by walking fast for a minimum of 30 mins at moderate intensity
(60-70% of max HR).
Arm group label:
HCP-Guided Exercise
Summary:
Pilot study evaluating the feasibility of a 2-4 week health care provider guided exercise
intervention prior to surgery for pancreatic cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Willingness and ability to participate in the study procedures
2. Pathologically confirmed pancreatic cancer
3. Candidate for neoadjuvant therapy followed by surgical resection with potentially
curative intent. Note: There is no limitation on duration of neoadjuvant therapy.
4. Planned to have at least 2 weeks after completing the last neoadjuvant therapy and
surgery
5. Over the age of 18
6. Ability to engage in physical activity as determined by physiatrist review after
completion of the Physical Activity Readiness questionnaire (PAR-Q) exercise survey
and chart review
7. Agree to study blood draws and tissue collection
Exclusion Criteria:
1. Evidence of metastatic disease
2. Inability to complete physical activity due to recent injury or surgery
3. Uncontrolled heart disease limiting physical activity
4. Participation in another interventional trial that excludes participation in this
protocol
5. Subjects who anticipate undergoing a procedure during the course of the trial that
will render them unable to engage in physical activity for more than 48 hours
6. Pregnant subjects
7. Individuals who lack the capacity to consent
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
NYU Langone Health Ambulatory Care Center
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Paul Oberstein, MD
Phone:
212-731-6120
Email:
paul.oberstein@nyulangone.org
Start date:
November 15, 2022
Completion date:
December 1, 2024
Lead sponsor:
Agency:
NYU Langone Health
Agency class:
Other
Source:
NYU Langone Health
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05483075
