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Ischemic Conditioning to Promote Microvascular Resiliency in Frail Individuals

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. 2 versions Re-verified since Sep 9, 2024, no change to tracked fieldsv4-v5
  2. Phase: Not applicable to Phase 2 Primary endpoints revised (2) · Enrollment target: 50 to 60v3 Show 2 more changesShow less
    • Primary endpoints revised (2)
    • Enrollment target: 50 to 60

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Apr 12, 2023 to May 2, 2023v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 12, 2023 to May 2, 2023
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to see how small blood vessels respond to the stress of high intensity exercise, and if a safe and simple intervention called ischemic conditioning can protect blood vessels from the stress of exercise. Participants will come in for 3 study visits and get home-based ischemic conditioning. At Study Visit 1, participants will be assessed for their frailty and physical function. Afterwards, they will perform an exercise test. At Study Visit 2, patients will undergo 2 microvascular assessments, perform a high-intensity exercise, then undergo the same 2 microvascular assessments again. Participants will be given a handheld sphygmomanometer and a blood pressure cuff to take home. Depending on which group the participants get randomized into, participants will place the blood pressure cuff around their non-dominant upper arm and inflate to either a low or high pressure for 2 weeks at home. Participants will repeat the same steps in Study Visit 2 for Study Visit 3. In addition, participants will also be assessed for their frailty and physical function.
Trial Details
NCT Number NCT05808686
Lead Sponsor Medical College of Wisconsin
Conditions Aging, Fragility, Endothelial Dysfunction
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov