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Active, Not Recruiting

NCT Number: NCT05692323

A Supervised Prehabilitation Program for Patients With Pancreatic Cancer

The purpose of this study is to assess the use of an exercise program in people with pancreatic cancer.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PREHAB

Other

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.

Primary outcomes

  1. PREHAB Feasibility

    Time frame: From Baseline to 3 Months

    PREHAB Program feasibility will be measured by tracking participant attendance at PREHAB sessions. PREHAB will be considered feasible if 50% of participants attend at least 60% of scheduled sessions. PREHAB session feasibility is defined as at least 50% of participants attending at least 60% of scheduled sessions

Secondary outcomes

  1. PREHAB Program Safety

    Time frame: From Baseline to 3 Months

    PREHAB program safety will be evaluated by monitoring unanticipated problems involving risk to subjects or others (UPIRSO). PREHAB Program Safety will be assessed through the reporting of unanticipated problems from the baseline visit through to the 3 Month visit.

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Acronym: PREHAB

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Jan 20, 2023
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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