Feasibility of a Health Care Provider Guided Exercise Intervention Prior to Surgical Resection of Pancreatic Cancer

NCT ID: NCT05483075

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-15
• Study Completion Date: 2024-08-14

Brief Summary

Pilot study evaluating the feasibility of a 2-4 week health care provider guided exercise intervention prior to surgery for pancreatic cancer.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

HCP-Guided Exercise

Participants will schedule twice-weekly in-person visits to conduct health care provider (HCP)-supervised exercise activity for a minimum of 30 minutes. At least 3 additional times per week, participants will conduct self-directed exercise at home. Activity and other outcomes will be monitored with an Actigraph Centrepoint Insight Watch.

The HCP guided therapy will continue on a weekly basis for at least 2 weeks and up to a maximum of 4 weeks.

Group Type: EXPERIMENTAL

HCP-Guided Exercise Training Program

Intervention Type: BEHAVIORAL

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).

Control

Participants will not participate in the HCP-guided exercise intervention but will wear the Actigraph Centrepoint Insight Watch.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

HCP-Guided Exercise Training Program

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).

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Oberstein, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Medical Center

Locations

NYU Langone Health Ambulatory Care Center

New York, New York, United States

Countries

United States

Other Identifiers

22-00289

Identifier Type: -

Identifier Source: org_study_id