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Prehabilitation of Frail Surgical Cancer Patients Using Remote Ischemic Preconditioning

Prehabilitation of Frail Surgical Cancer Patients Using Remote Ischemic Preconditioning

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03853473
Acronym
Prehab
Enrollment
17
Registered
2019-02-25
Start date
2019-02-22
Completion date
2023-03-01
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer, Fragility, Prehabilitation, Surgery

Brief summary

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.

Detailed description

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.

Interventions

PROCEDURERemote Ischemic Preconditioning

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.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Medical College of Wisconsin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Masking description

Participants are randomized by the study statistician to receive either the intervention (remote ischemic conditioning) or standard of care. Participants cannot be blinded using this model.

Intervention model description

Prospective, Randomized, Blinded, Controlled Trial

Eligibility

Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
6 Minute Walk Test Distance (Pre Surgery)Pre-SurgeryThe investigators will compare the distance study participants can walk in 6 minutes in the pre-surgical period as a measure of frailty.

Secondary

MeasureTime frameDescription
6 Minute Walk Test Distance (Post Surgery)Years 1-3The investigators will compare the distance study participants walk in 6-minutes 4-weeks post-surgery as a secondary outcome of surgical recovery.
Timed Up and Go (Post Surgery)Years 1-3The 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.
Hand Grip Strength (Post Surgery)Years 1-3The investigators will compare handgrip strength 4-weeks post surgery as a secondary measure of surgical recovery.
Intraoperative Blood Pressure VariabilityYears 1-3The investigators will measure the variability of blood pressure during the intraoperative period using the anesthetic record.
10 Meter Walk Test (Pre Surgery)Pre-SurgeryThe investigators will compare the speed study participants walk over 10 meters in the pre-surgical period as a secondary measure of frailty.
Timed Up and Go (Pre Surgery)Years 1-3The 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.
Hand Grip Strength (Pre Surgery)Years 1-3The investigators will compare handgrip strength in the presurgical period as a secondary measure of frailty.
10 Meter Walk Test (Post Surgery)Years 1-3The investigators will compare the speed study participants walk 10 meters 4-weeks post-surgery as a secondary outcome of surgical recovery.

Other

MeasureTime frameDescription
Length of Hospital StayYears 1-3The investigators will document how long participants in both study groups (RIPC or standard of care) stay in the hospital following surgery.
All Cause MortalityYears 1-3The investigators will document any deaths that occur during hospitalization following surgery.
Number of Hours of RehabilitationYears 1-3The investigators will document the number of hours of physical therapy each study participant participates in following surgery.

Countries

United States

Participant flow

Pre-assignment details

Participants were consented following their clinical appointments. Group assignment did not occur until after pre-testing, which often occurred on a separate day.

Participants by arm

ArmCount
Standard of Care
Study participants will receive standard of care.
6
Remote Ischemic Preconditioning
Study participants will perform remote ischemic preconditioning daily, at home, from study enrollment to their date of surgery. Remote Ischemic Preconditioning: 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.
6
Total12

Baseline characteristics

CharacteristicStandard of CareRemote Ischemic PreconditioningTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
6 Participants4 Participants10 Participants
Age, Categorical
Between 18 and 65 years
0 Participants2 Participants2 Participants
Age, Continuous76 years
STANDARD_DEVIATION 5
71 years
STANDARD_DEVIATION 8
74 years
STANDARD_DEVIATION 7
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
6 Participants6 Participants12 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
1 Participants1 Participants2 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
5 Participants5 Participants10 Participants
Region of Enrollment
United States
6 participants6 participants12 participants
Sex: Female, Male
Female
4 Participants3 Participants7 Participants
Sex: Female, Male
Male
2 Participants3 Participants5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 60 / 6
other
Total, other adverse events
0 / 61 / 6
serious
Total, serious adverse events
0 / 60 / 6

Outcome results

Primary

6 Minute Walk Test Distance (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.

Time frame: Pre-Surgery

ArmMeasureValue (MEAN)Dispersion
Standard of Care6 Minute Walk Test Distance (Pre Surgery)369 MetersStandard Deviation 60
Remote Ischemic Preconditioning6 Minute Walk Test Distance (Pre Surgery)432 MetersStandard Deviation 42
Secondary

10 Meter Walk Test (Post Surgery)

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

Time frame: Years 1-3

Secondary

10 Meter Walk Test (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.

Time frame: Pre-Surgery

ArmMeasureValue (MEAN)Dispersion
Standard of Care10 Meter Walk Test (Pre Surgery)1.12 Meters/SecondStandard Deviation 0.17
Remote Ischemic Preconditioning10 Meter Walk Test (Pre Surgery)1.27 Meters/SecondStandard Deviation 0.04
Secondary

6 Minute Walk Test Distance (Post Surgery)

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

Time frame: Years 1-3

Secondary

Hand Grip Strength (Post Surgery)

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

Time frame: Years 1-3

Secondary

Hand Grip Strength (Pre Surgery)

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

Time frame: Years 1-3

Secondary

Intraoperative Blood Pressure Variability

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

Time frame: Years 1-3

Secondary

Timed Up and Go (Post Surgery)

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.

Time frame: Years 1-3

Secondary

Timed Up and Go (Pre Surgery)

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.

Time frame: Years 1-3

Other Pre-specified

All Cause Mortality

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

Time frame: Years 1-3

Other Pre-specified

Length of Hospital Stay

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

Time frame: Years 1-3

Other Pre-specified

Number of Hours of Rehabilitation

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

Time frame: Years 1-3

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026