Ischemic Conditioning to Promote Microvascular Resiliency in Frail Individuals
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65-85
SponsorMedical College of Wisconsin
About 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Women and men ages 65-85 years of age
Disqualifiers
Myocardial infarction in last 6 months
morbid obesity (BMI >40)
heart failure
uncontrolled hypertension
Trial design
Design model
Parallel
Treatments tested in this trial
Ischemic Conditioning
Other interventionWe 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. For the Ischemic Conditioning-Low group participants, the cuff will be inflated to 10 mmHg instead. 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Ischemic Conditioning-LowSham comparator 1 intervention
Group B: Ischemic Conditioning-HighExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Acetylcholine-mediated dilation
Cutaneous vascular conductance in response to acetylcholine infusion will be calculated as laser Doppler flux / mean arterial pressure
Time frame
2 hours2
Change in Perfused Vessel Density
Total vessel density (TVD) will be calculated using the DeBacker Score manual analysis on all images that have a minimum microcirculation image quality score (MIQS) of 10. Perfused vessel density (PVD) will be calculated by multiplying total vessel density (TVD) x proportion of perfused vessels (PPV%).
Time frame
0.5 hoursSponsors and contacts
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Source ClinicalTrials.gov