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Completed

NCT Number: NCT03853473

Prehabilitation of Frail Surgical Cancer Patients Using Remote Ischemic Preconditioning

This project will examine the efficacy of a simple, cost-effective, non-invasive intervention, called remote ischemic preconditioning (RIPC), to reduce frailty in pre-surgical, frail, elderly patients with colon cancer. The investigators hypothesize that RIPC will reduce frailty in the pre-surgical period (as assessed by distance walked during the 6-minute walk test), improve functional capacity 4-weeks postoperatively, and reduce intraoperative blood pressure variability. If successful, future studies will examine the efficacy of RIPC to improve surgical outcomes in frail cancer patients.

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Key information

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

About this study

Remote ischemic preconditioning (RIPC) was first described three decades ago as an intervention to protect vital organs from ischemic injury. RIPC occurs when a tissue is made transiently ischemic (5 minutes) for repeated bouts (5 times) prior to the longer ischemic insult. Recently it has been shown exercise performance and motor function are improved in young, healthy individuals when RIPC is performed on the arm or leg using a simple blood pressure cuff to occlude blood flow to the limb. The application of RIPC to individuals with reduced functional capacity, however, is largely unexplored. The study team was the first to apply RIPC to chronic stroke survivors with reduced physical function, and two weeks of RIPC increases walking speed, paretic muscle strength and fatigue resistance. Advanced age and cancer are both dramatic accelerators of frailty and frail patients have poor surgical outcomes. Therefore, the investigators propose to apply this non-invasive, simple intervention as a "prehabilitation" therapy to elderly patients with colon cancer during the perioperative period. The investigators will enroll 96 colon cancer patients aged 55-85 who are ≥17 days prior to scheduled curative resection of colon cancer. After study enrollment, all participants will perform the six-minute walk test as a measure of frailty. Participants will then be randomized to receive either RIPC on their upper, non-dominant arm daily for 14 days prior to surgery, or to receive standard of care (no intervention). After 14 days of either RIPC or no intervention, the 6-minute walk test will be re-assessed within 48 hours of surgery. The primary study outcome will be the difference in six-minute walk distance (in meters) between patients in the RIPC group vs. those in the standard of care group following the two-week pre-operative intervention period (Aim 1). The investigators hypothesize that patients in the RIPC group will walk further during the six-minute walk test than those in the standard of care group due to the well-defined effects of RIPC to improve athletic performance, cardiovascular function, and strength in healthy individuals. A secondary study outcome will be the difference in six-minute walk test distance between the RIPC and standard of care group 4-weeks postoperatively (Aim 2). The investigators hypothesize that patients in the RIPC group will have more rapid recovery from surgery, which would be evidenced by increased walking endurance post-operatively. Another secondary study outcome will be the amount of intraoperative blood pressure variability (time systolic pressure is above or below 135 mmHg or 95 mmHg, respectively) between the RIPC and control groups (Aim 3). The investigators hypothesize that RIPC will reduce intraoperative blood pressure variability due to the well described effects of RIPC to improve systemic vascular function. Future larger studies will examine the effects of RIPC prehabilitation on surgical outcomes such as length of hospital stay and all-cause mortality in frail, elderly patients with colon cancer as well as other patient cohorts with reduced functional capacity.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Be between the ages of 55-85
  • Have a positive diagnosis of colon cancer or suspected colon cancer based on pathology report
  • Be scheduled for curative resection of non-metastatic colon cancer
  • Have a 6-Minute Walk Test distance ≤80% of predicted value based on age and sex.

Exclusion criteria

  • Condition which prevents walking
  • Any condition in which compression of the arm or transient ischemia is contraindicated (e.g. wounds in the arm)
  • Neurodegenerative disorder
  • Unstable angina in previous month
  • Myocardial infarction during previous month.

Treatment and study plan

Remote ischemic preconditioning

Procedure

Remote Ischemic Preconditioning (RIPC) occurs when a limb is made transiently ischemic (5 minutes) using a simple blood pressure cuff. We are proposing that study participants in the RIPC group perform the intervention daily at home for at least 14 days prior to scheduled surgery. They will inflate a blood pressure cuff on the upper portion of their nondominant arm, inflate it to 225 mmHg for 5 minutes, release the cuff for 5 minutes, and repeat this 5 times (for a total of 45 minutes). A study coordinator will monitor compliance with phone calls and daily log sheets that must be filled out.

Primary outcomes

  1. 6 Minute Walk Test Distance (Pre Surgery)

    Time frame: Pre-Surgery

    The investigators will compare the distance study participants can walk in 6 minutes in the pre-surgical period as a measure of frailty.

Secondary outcomes

  1. 10 Meter Walk Test (Pre Surgery)

    Time frame: Pre-Surgery

    The investigators will compare the speed study participants walk over 10 meters in the pre-surgical period as a secondary measure of frailty.

  2. Timed Up and Go (Pre Surgery)

    Time frame: Years 1-3

    The investigators will compare the speed study participants stand from a chair, walk three meters, turn around, walk back to the chair, and sit (timed up and go test) in the pre-surgical period as a secondary measure of frailty.

  3. Hand Grip Strength (Pre Surgery)

    Time frame: Years 1-3

    The investigators will compare handgrip strength in the presurgical period as a secondary measure of frailty.

  4. 6 Minute Walk Test Distance (Post Surgery)

    Time frame: Years 1-3

    The investigators will compare the distance study participants walk in 6-minutes 4-weeks post-surgery as a secondary outcome of surgical recovery.

  5. 10 Meter Walk Test (Post Surgery)

    Time frame: Years 1-3

    The investigators will compare the speed study participants walk 10 meters 4-weeks post-surgery as a secondary outcome of surgical recovery.

  6. Timed Up and Go (Post Surgery)

    Time frame: Years 1-3

    The investigators will compare the speed study participants stand from a chair, walk three meters, turn around, walk back to the chair, and sit (timed up and go test) 4-weeks post surgery as a secondary measure of surgical recovery.

  7. Hand Grip Strength (Post Surgery)

    Time frame: Years 1-3

    The investigators will compare handgrip strength 4-weeks post surgery as a secondary measure of surgical recovery.

  8. Intraoperative Blood Pressure Variability

    Time frame: Years 1-3

    The investigators will measure the variability of blood pressure during the intraoperative period using the anesthetic record.

Other outcomes

  1. Number of Hours of Rehabilitation

    Time frame: Years 1-3

    The investigators will document the number of hours of physical therapy each study participant participates in following surgery.

  2. All Cause Mortality

    Time frame: Years 1-3

    The investigators will document any deaths that occur during hospitalization following surgery.

  3. Length of Hospital Stay

    Time frame: Years 1-3

    The investigators will document how long participants in both study groups (RIPC or standard of care) stay in the hospital following surgery.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: Prehab

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Feb 25, 2019
Registry last updated
Sep 19, 2024

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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