N/A
N=12
Prehabilitation of Frail Surgical Cancer Patients Using Remote Ischemic Preconditioning
Colon Cancer · Fragility · Prehabilitation · Surgery
Bottom Line
View on ClinicalTrials.gov: NCT03853473 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: 6 Minute Walk Test Distance (Pre Surgery) — 369; 432 Meters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Remote Ischemic Preconditioning (Procedure)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Medical College of Wisconsin
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 6 Minute Walk Test Distance (Pre Surgery) |
369; 432 | — |
| SECONDARY 10 Meter Walk Test (Pre Surgery) |
1.12; 1.27 | — |
| SECONDARY Timed Up and Go (Pre Surgery) |
— | — |
| SECONDARY Hand Grip Strength (Pre Surgery) |
— | — |
| SECONDARY 6 Minute Walk Test Distance (Post Surgery) |
— | — |
| SECONDARY 10 Meter Walk Test (Post Surgery) |
— | — |
| SECONDARY Timed Up and Go (Post Surgery) |
— | — |
| SECONDARY Hand Grip Strength (Post Surgery) |
— | — |
| SECONDARY Intraoperative Blood Pressure Variability |
— | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03853473). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.