Pancreatic ResectionNCT03688867
Prehabilitation in Pancreatic Surgery
A study testing Prehabilitation regimen in people with Pancreatic Resection and Preoperative Frailty, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to use functional studies to study the effectiveness of prehabilitation prior to surgery. The investigators know that stronger patients have better outcomes after surgery compared to weaker patients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Pancreatic Resection, Preoperative Frailty
- What is being tested?
- Prehabilitation regimen
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2019to 18 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing pancreatic resection over a six-month enrollment
Who cannot join
- unable to sign a consent
- require a translator in order to sign the consent
- Non-pancreatic resection candidates
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
The purpose of this study is to use functional studies to study the effectiveness of prehabilitation prior to surgery. The investigators know that stronger patients have better outcomes after surgery compared to weaker patients. This study will help the study team determine if prehabilitation can make patients stronger prior to surgery. It is hoped by learning more about frailty and prehabilitation strategies may be developed to minimize or prevent complications in the future. Participants are being asked to participate in this study because they are going to have a pancreatic procedure.
Read the detailed description
This study aims to determine if a prehabilitation program can improve three objective frailty metrics and to describe the level of physical activity of pancreatectomy patients prior to their planned resection. Patients undergoing pancreatectomy will undergo routine preoperative work up: Staging PET/CT Chest/Abdomen/Pelvis, and biochemical work up (CBC, CMP, CA 19-9, prealbumin/albumin).
During the initial consultation, the patients' resting vitals (including weight) will be recorded. They will then perform the grip strength, 30s CST, and 6MWT to establish their baseline frailty metrics. Available baseline laboratory values (CBC, CMP including albumin), will also be recorded. Research personnel will then provide them with a fitness tracker, stress ball, and prehabilitation routine to follow at home until the day of surgery. They will also be asked to keep a physical log of their completed physical activities.
The patients will then complete the prehabilitation program during the time between the initial consultation and date of surgery, which typically occurs 3-4 weeks after the initial consultation date.
On the day of surgery, patients will turn in their physical log and their fitness tracker. Data from the fitness tracker will be downloaded onto a Cleveland Clinic encrypted computer. A set of resting vitals will be recorded (again including weight) and the patients will then be asked to perform the three-frailty metrics (grip strength, 30s CST, and 6MWT). After this, the patients will not require any additional testing.
- Conditions
- Pancreatic Resection, Preoperative Frailty
- Being tested
- Prehabilitation regimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation regimenBehavioural
The intervention targets individual behavior, specifically a patient's proclivity to exercise prior to pancreatic resection. The prehabilitation program is tailored to the three most commonly used objective frailty metrics currently available and will be implemented during the initial consultation visit in the surgery outpatient clinic, where patients will undergo baseline testing and then provided with a fitness tracker and stress ball.
Additionally, they will be provided with an activity log to keep track of their daily activity. Shown below is the activity log.
| Study group | Role | What they receive |
|---|---|---|
| At-home prehabilitation regimen | Experimental | 1. Grip strength: Squeeze a stress ball in your hand, holding it squeezed for 5 seconds. Perform this at least thirty times with each hand over the course of a day.
2. Lower body strength: Perform at least one hundred chair sit-stands in a day.
3. Endurance: Walking at least 7,500 steps in a day. Receives: Behavioral: Prehabilitation regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in grip strength
Participant's grip strength will be measured before and after intervention with a Jamar Dynamometer as follows:
- Hold both arms at 90-degree angles with the arms held close to the body
- Perform isometric contraction for 5 seconds and measure the pressure generated from this
- Both handgrips will be measured three times each and averaged. The greater of the two averages will be recorded
Measured: 4 weeks
Change in number of chair stands in 30 seconds (chair stand test)
The change in the number of times the participant can fully stand up from a seated position in 30 seconds will be measured as follows:
Participant will
- Sit in the middle of the chair
- Place their hands on the opposite shoulder crossed at the wrists
- Keep their feet flat on the floor
- Keep their back straight and keep their arms against your chest
- On "Go," rise to a full standing position and then sit back down again
- Repeat this for 30 seconds
- If the participant must use his/her arms to stand, stop the test. A score of "0" will be recorded for the number and score. The number of times the patient comes to a full standing position in 30 seconds will be counted. If the patient is over halfway to a standing position when 30 seconds have elapsed, it will count as a stand. Number of times the patient stands in 30 seconds will be recorded.
Measured: 4 weeks
Change in vitals and distance walked via 6-minute walk test
The change in the participant's 6-minute walk test metrics (vitals and distance walked)
- Participant's baseline vitals will be recorded, including pulse oximetry prior to walking
- Participant will walk as far as possible in 6 minutes at a comfortable pace, but not at a run or jog.
- If they become short of breath or tired, they may slow down, stop, or rest as necessary. Participant may lean against the wall while resting, but will resume walking as soon as they are able.
- Participant will walk down to the end of the hall, turn around and walk back. They will repeat this until the six minutes have expired.
- If the participant is unable to complete the full six-minute walk, then the time and distance walked will be recorded as well as the reason for stopping early.
Vitals will be recorded immediately after walking
Measured: 4 weeks
Secondary outcomes (6)
Number of grip exercises
Participants will complete and record number of stress ball squeezes (Squeezing stress ball in hand and holding it squeezed for 5 seconds) during the prehabilitation period
Number of times squeezed with right hand and number of times squeezed with left hand will be recorded.
Measured: 4 weeks
Number of chair sit stands performed
Measures lower body strength: Participants will measure the number of chair sit stands they perform in a day during the prehabilitation period.
Measured: 4 weeks
Number of steps walked
Participants will track the number of steps they walk per day during the prehabilitation period via the provided fitness activity tracker (Garmin Vivofit 4).
Measured: 4 weeks
Heart rate
Participants will track their heart rate during the prehabilitation period via the provided fitness activity tracker (Garmin Vivofit 4).
Measured: 4 weeks
Energy expenditure
Participant's energy expenditure will be tracked via the data from the supplied fitness tracker (Garmin Vivofit 4).
Measured: 4 weeks
Weight change from the baseline
Participant's weight change from the baseline initial consultation to the day of operation will be recorded.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start19 Mar 2019
- Primary completion18 Feb 2021
- Study completion18 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic ResectionStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew Walsh, MD, Principal investigator, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688867
- Sponsor's protocol ID
- CASE4218
- Status last verified
- Jan 2023
- First submitted
- 4 Sep 2018
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation in Pancreatic Surgery
- ClinicalTrials.gov ID
- NCT03688867
- Acronym / sponsor ID
- CASE4218
- Conditions
- Pancreatic Resection, Preoperative Frailty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- 18 Feb 2021 (actual)
- Study completion
- 18 Feb 2021 (actual)
- First posted
- 28 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to use functional studies to study the effectiveness of prehabilitation prior to surgery. The investigators know that stronger patients have better outcomes after surgery compared to weaker patients. This study will help the study team determine if prehabilitation can make patients stronger prior to surgery. It is hoped by learning more about frailty and prehabilitation strategies may be developed to minimize or prevent complications in the future. Participants are being asked to participate in this study because they are going to have a pancreatic procedure.
Detailed description
This study aims to determine if a prehabilitation program can improve three objective frailty metrics and to describe the level of physical activity of pancreatectomy patients prior to their planned resection. Patients undergoing pancreatectomy will undergo routine preoperative work up: Staging PET/CT Chest/Abdomen/Pelvis, and biochemical work up (CBC, CMP, CA 19-9, prealbumin/albumin).
During the initial consultation, the patients' resting vitals (including weight) will be recorded. They will then perform the grip strength, 30s CST, and 6MWT to establish their baseline frailty metrics. Available baseline laboratory values (CBC, CMP including albumin), will also be recorded. Research personnel will then provide them with a fitness tracker, stress ball, and prehabilitation routine to follow at home until the day of surgery. They will also be asked to keep a physical log of their completed physical activities.
The patients will then complete the prehabilitation program during the time between the initial consultation and date of surgery, which typically occurs 3-4 weeks after the initial consultation date.
On the day of surgery, patients will turn in their physical log and their fitness tracker. Data from the fitness tracker will be downloaded onto a Cleveland Clinic encrypted computer. A set of resting vitals will be recorded (again including weight) and the patients will then be asked to perform the three-frailty metrics (grip strength, 30s CST, and 6MWT). After this, the patients will not require any additional testing.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| At-home prehabilitation regimen | Experimental | Behavioral: Prehabilitation regimen1. Grip strength: Squeeze a stress ball in your hand, holding it squeezed for 5 seconds. Perform this at least thirty times with each hand over the course of a day. 2. Lower body strength: Perform at least one hundred chair sit-stands in a day. 3. Endurance: Walking at least 7,500 steps in a day. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing pancreatic resection over a six-month enrollment
Key exclusion criteria (3 listed)
- unable to sign a consent
- require a translator in order to sign the consent
- Non-pancreatic resection candidates
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prehabilitation regimenThe intervention targets individual behavior, specifically a patient's proclivity to exercise prior to pancreatic resection. The prehabilitation program is tailored to the three most commonly used objective frailty metrics currently available and will be implemented during the initial consultation visit in the surgery outpatient clinic, where patients will undergo baseline testing and then provided with a fitness tracker and stress ball. Additionally, they will be provided with an activity log to keep track of their daily activity. Shown below is the activity log. | Behavioural | At-home prehabilitation regimen |
Primary outcome
Change in grip strength
Time frame: 4 weeks
Participant's grip strength will be measured before and after intervention with a Jamar Dynamometer as follows: 1. Hold both arms at 90-degree angles with the arms held close to the body 2. Perform isometric contraction for 5 seconds and measure the pressure generated from this 3. Both handgrips will be measured three times each and averaged. The greater of the two averages will be recorded
Change in number of chair stands in 30 seconds (chair stand test)
Time frame: 4 weeks
The change in the number of times the participant can fully stand up from a seated position in 30 seconds will be measured as follows: Participant will 1. Sit in the middle of the chair 2. Place their hands on the opposite shoulder crossed at the wrists 3. Keep their feet flat on the floor 4. Keep their back straight and keep their arms against your chest 5. On "Go," rise to a full standing position and then sit back down again 6. Repeat this for 30 seconds 7. If the participant must use his/her arms to stand, stop the test. A score of "0" will be recorded for the number and score. The number of times the patient comes to a full standing position in 30 seconds will be counted. If the patient is over halfway to a standing position when 30 seconds have elapsed, it will count as a stand. Number of times the patient stands in 30 seconds will be recorded.
Change in vitals and distance walked via 6-minute walk test
Time frame: 4 weeks
The change in the participant's 6-minute walk test metrics (vitals and distance walked) 1. Participant's baseline vitals will be recorded, including pulse oximetry prior to walking 2. Participant will walk as far as possible in 6 minutes at a comfortable pace, but not at a run or jog. 3. If they become short of breath or tired, they may slow down, stop, or rest as necessary. Participant may lean against the wall while resting, but will resume walking as soon as they are able. 4. Participant will walk down to the end of the hall, turn around and walk back. They will repeat this until the six minutes have expired. 5. If the participant is unable to complete the full six-minute walk, then the time and distance walked will be recorded as well as the reason for stopping early. Vitals will be recorded immediately after walking
6 secondary outcomes
Number of grip exercises
Time frame: 4 weeks
Number of chair sit stands performed
Time frame: 4 weeks
Number of steps walked
Time frame: 4 weeks
Heart rate
Time frame: 4 weeks
Energy expenditure
Time frame: 4 weeks
Weight change from the baseline
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Walsh, MD principal investigator
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation regimen in people with Pancreatic Resection and Preoperative Frailty, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in grip strength (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.