Ischemic Conditioning for Frailty
Recruiting in Palo Alto (17 mi)
Age: 65+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Medical College of Wisconsin
Disqualifiers: Myocardial infarction, Morbid obesity, Heart failure, others
No Placebo Group
Prior Safety Data
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
How is the treatment Ischemic Conditioning different from other treatments for frailty?
Ischemic Conditioning is unique because it involves temporarily restricting blood flow to a limb to protect other parts of the body, like the heart, from damage. This method is different from typical treatments as it uses the body's natural response to stress to potentially improve health outcomes.
12345Eligibility Criteria
This trial is for men and women aged 65-85 who may be experiencing frailty or have poor blood vessel function. Participants should be able to perform high-intensity exercise and commit to three study visits along with home-based treatments using a blood pressure cuff.Inclusion Criteria
I am between 65 and 85 years old.
Exclusion Criteria
I have had blood clots in my arms or legs.
My high blood pressure is not under control.
My BMI is over 40.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Assessment
Participants complete assessments on frailty and physical function and perform an exercise test
1 day
1 visit (in-person)
Treatment
Participants undergo microvascular assessments, perform high-intensity exercise, and engage in home-based ischemic conditioning for 2 weeks
2 weeks
2 visits (in-person), daily home-based intervention
Follow-up
Participants are monitored for changes in microvascular function and frailty after treatment
1 day
1 visit (in-person)
Participant Groups
The trial tests ischemic conditioning, which involves temporarily restricting blood flow with a cuff, to see if it can protect small blood vessels from stress during high-intensity exercise in older adults.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ischemic Conditioning-HighExperimental Treatment1 Intervention
We will use a randomized block design to randomize individuals into either Ischemic Conditioning-Low or Ischemic Conditioning-High group using an online randomizer. A handheld sphygmomanometer and blood pressure cuff will be given to study participants. For the Ischemic Conditioning-High group participants, while sitting, the cuff will be placed around the non-dominant upper arm and inflated to 225 mmHg for 5 min, then released for a 5-min recovery period. A 5-min inflation period is most used. Five cycles of inflation/recovery will be performed. All participants will perform the intervention daily for 2 weeks. Participants will complete daily log sheets documenting the time and pressure of each cuff inflation.
Group II: Ischemic Conditioning-LowPlacebo Group1 Intervention
We will use a randomized block design to randomize individuals into either Ischemic Conditioning-Low or Ischemic Conditioning-High group using an online randomizer. A handheld sphygmomanometer and blood pressure cuff will be given to study participants. For the Ischemic Conditioning-Low group participants, while sitting, the cuff will be placed around the non-dominant upper arm and inflated to 10 mmHg for 5 min, then released for a 5-min recovery period. A 5-min inflation period is most used. Five cycles of inflation/recovery will be performed. All participants will perform the intervention daily for 2 weeks. Participants will complete daily log sheets documenting the time and pressure of each cuff inflation.
Ischemic Conditioning is already approved in China for the following indications:
🇨🇳 Approved in China as Remote Ischemic Conditioning for:
- Acute ischemic stroke
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Froedtert HospitalWauwatosa, WI
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Who Is Running the Clinical Trial?
Medical College of WisconsinLead Sponsor
References
Remote Ischemic Conditioning in Patients with Acute Coronary Syndromes: A Systematic Review with Meta-Analysis and Trial Sequential Analysis. [2022]To evaluate the efficacy of remote ischemic conditioning (RIC) as compared to no conditioning on clinical endpoints in acute coronary syndromes (ACS) patients undergoing percutaneous coronary intervention (PCI).
Repeated remote ischemic postconditioning protects against adverse left ventricular remodeling and improves survival in a rat model of myocardial infarction. [2011]Remote ischemic conditioning induced by repeated episodes of transient limb ischemia is a clinically applicable method for protecting the heart against injury at the time of reperfusion.
Daily remote ischaemic conditioning following acute myocardial infarction: a randomised controlled trial. [2019]Remote ischaemic conditioning (rIC) is a cardioprotective tool which has shown promise in preclinical and clinical trials in the context of acute ischaemia. Repeated rIC post myocardial infarction may provide additional benefits which have not previously been tested clinically.
Repeated remote ischemic conditioning attenuates left ventricular remodeling via exosome-mediated intercellular communication on chronic heart failure after myocardial infarction. [2015]Remote ischemic conditioning (RIC) by repeated treatment of transient limb ischemia is a clinically applicable method for protecting the heart against injury at the time of reperfusion. In this study, we investigated the effects of repeated RIC on cardiac dysfunction after myocardial infarction (MI).
[Cardioprotection via the arm? : How a blood pressure cuff decreases infarct sizes]. [2019]Cardiovascular diseases and especially myocardial infarctions are responsible for a high morbidity and mortality throughout Europe. An essential aspect of myocardial infarction is ischemia/reperfusion injury which represents the necrosis of myocytes following reperfusion. One possible option to counteract ischemia/reperfusion injury is the much researched process of remote ischemic conditioning (RIC), whereby a certain tissue (e.g. skeletal muscle) is subjected to several cycles of short periods (e.g. 5 min) of ischemia and reperfusion and leads to the protection of another organ (e.g. the heart). Despite substantial efforts to elucidate the underlying mechanisms during the last decades, this phenomenon is not yet completely understood. Clinical studies mainly concentrated on laboratory and radiological parameters, which led to better understanding of RIC; however, large clinical studies evaluating the possible influence on mortality are still lacking. This review article provides an introduction to RIC and summarizes the current understanding of known pathomechanisms and the results of important clinical studies.