ClinicalTrials.gg
RecruitingNCT05808686Updated Sep 23, 2025

Ischemic Conditioning to Promote Microvascular Resiliency in Frail Individuals

A Phase 2 interventional study of Ischemic Conditioning in Aging, Fragility and Endothelial Dysfunction, sponsored by Medical College of Wisconsin. Recruiting at 1 site in United States. Open to participants aged 65 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-23.

Sponsored by Medical College of Wisconsin · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started May 2023; still recruiting 3 years 6 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
65 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 148 studies in Aneurysm with a site in United States — 31 open to participants now, 38 under way, none of them phase 3. Aneurysm · United States.

Planned enrollment
56th of 111
60 · median 60
Started
2023
with 2 others
Phase 2
9 of 148
2 open now
Primary completion
2028-12
later than 25 of 37 live
Registered
132nd of 148
by date

Among the 148 studies in Aneurysm with a site in United States, this one is the 56th largest by planned enrollment of the 111 interventional ones that give a count, is one of 3 that started in 2023, is one of 9 in phase 2, reaches primary completion later than 25 of the 37 other live ones, and was the 132nd registered.

Aneurysm

381 studies on the registry are indexed under Aneurysm; 78 are open to participants now.

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Open to participants now

31 of the 148 studies in Aneurysm with a site in United States are open now. Recruiting first, the newest first:

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A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 67 Aneurysm studies recruiting now, 42 (63%) set no upper age limit and 7 (10%) stop at 75 or younger; 6 take children under 18; 9 take healthy volunteers.

This study: 65 Years to 85 Years · all sexes · healthy volunteers too.

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02

Study summary

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.

Read the detailed description

In elderly individuals the small blood vessels that regulate blood flow to organs and other tissues can become damaged when they are exposed to stress, which can lead to complications following stressful events like surgery. In this study we will examine how these blood vessels respond to the stress of high intensity exercise, and if a safe and simple intervention called ischemic conditioning can increase resiliency of these vessels.

Our previous work showed that conditioned athletes are protected from the stress of a single, high intensity exercise bout whereas non-athletes are not. Others have shown that elderly individuals have reduced large artery function following the high intensity exercise. This study will be the first to examine how the small blood vessels respond to this stress in the elderly. Participants will be asked to come in for 3 study visits.

Study Visit 1

  1. Complete assessments on frailty and physical function
  2. Complete an exercise test using either a total body recumbent stepper or a bicycle and pedal in a seated position

Study Visit 2

  1. Undergo a blood draw to measure plasma sphingolipids
  2. Have a CytoCam device take images of small vessels inside their mouth
  3. Be assessed by the Laser Doppler Flowmeter while small doses of a vasodilator called acetylcholine are infused into the skin and the local temperature increases
  4. Complete a high-intensity interval exercise on a bicycle or an elliptical machine
  5. Have a CytoCam device take images of small vessels inside their mouth
  6. Be assessed by the Laser Doppler Flowmeter while small doses of a vasodilator called acetylcholine are infused into the skin and the local temperature increases

Home-based Ischemic Conditioning

  1. Get a handheld sphygmomanometer and a blood pressure cuff to take home.
  2. Depending on which group the participants get randomized into, participants will place blood pressure cuff around non-dominant upper arm and inflate to either a low or high pressure.
  3. This intervention will be completed 5 times a day for 2 weeks

Visit 3

  1. Undergo a blood draw to measure plasma sphingolipids
  2. Have a CytoCam device take images of small vessels inside their mouth
  3. Be assessed by the Laser Doppler Flowmeter while small doses of a vasodilator called acetylcholine are infused into the skin and the local temperature increases
  4. Complete assessments on frailty and physical function
  5. Complete an exercise test using either a total body recumbent stepper or a bicycle and pedal in a seated position
  6. Complete a high-intensity interval exercise on a bicycle or an elliptical machine
  7. Have a CytoCam device take images of small vessels inside their mouth
  8. Be assessed by the Laser Doppler Flowmeter while small doses of a vasodilator called acetylcholine are infused into the skin and the local temperature increases
03

Conditions studied

  • Aging
  • Fragility
  • Endothelial Dysfunction

Keywords

  • Vasodilation
  • Exercise
  • Fitness
04

Who can participate

Ages eligible
65 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women and men ages 65-85 years of age

Exclusion criteria

Exclusion Criteria:

  • Myocardial infarction in last 6 months
  • morbid obesity ( >40)
  • heart failure
  • uncontrolled hypertension
  • other condition that precludes high intensity exercise (ex, neurological disorder, acute systemic infection)
  • history of blood clots in the extremities
  • any condition in which compression of the arm or transient ischemia is (e.g., wounds in the arm).
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Sham comparator
    Ischemic Conditioning-Low

    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.

    Other: Ischemic Conditioning

  • Experimental
    Ischemic Conditioning-High

    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.

    Other: Ischemic Conditioning

Interventions

  • OtherIschemic Conditioning

    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. 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.

06

What researchers measure

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 hours

  2. 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 hours

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — There are no current plans to share individual participant data with other researchers.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2023 (actual). Primary completion is estimated for Dec 2028, 67 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 28, 2023
First posted
Apr 11, 2023
StartActual
May 2, 2023
Primary completionEst.
Dec 2028
CompletionEst.
Dec 2029
Last update
Sep 23, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05808686
Responsible party
Matthew J. Durand (Associate Professor, Medical College of Wisconsin) — Principal investigator
First posted
Apr 11, 2023
Start date
May 2, 2023
Primary completion
Dec 2028 (estimated)
Completion
Dec 2029 (estimated)
Last update
Sep 23, 2025

Study contacts

Jennifer Nguyen
Contact
jnguyen@mcw.edu
414-955-1917
Matt Durand
Contact
mdurand@mcw.edu
4149555619

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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