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Prehabilitation of Frail Surgical Cancer Patients Using Remote Ischemic Preconditioning

NCT03853473 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-09-19

Study results available
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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.

Conditions

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Matthew J Durand, Ph.D. · Medical College of Wisconsin

  • Julie K Freed, MD, Ph.D. · Medical College of Wisconsin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-22
Primary Completion
2023-02-01
Completion
2023-03-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03853473 on ClinicalTrials.gov