AgingPhase 2NCT05808686
Ischemic Conditioning to Promote Microvascular Resiliency in Frail Individuals
A Phase 2 study testing Ischemic Conditioning in people with Aging and Fragility, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Fragility, Endothelial Dysfunction
- What is being tested?
- Ischemic Conditioning
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2023to Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Women and men ages 65-85 years of age
Who cannot join
- Myocardial infarction in last 6 months
- morbid obesity (BMI >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 contraindicated (e.g., wounds in the arm).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Froedtert Hospital
Wauwatosa, Wisconsin, 53226
Jennifer Nguyen, 414-955-1917, jnguyen@mcw.edu
Matt Durand, PhD
About this study
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
- Complete assessments on frailty and physical function
- Complete an exercise test using either a total body recumbent stepper or a bicycle and pedal in a seated position
Study Visit 2
- Undergo a blood draw to measure plasma sphingolipids
- Have a CytoCam device take images of small vessels inside their mouth
- 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
- Complete a high-intensity interval exercise on a bicycle or an elliptical machine
- Have a CytoCam device take images of small vessels inside their mouth
- 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
- Get a handheld sphygmomanometer and a blood pressure cuff to take home.
- 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.
- This intervention will be completed 5 times a day for 2 weeks
Visit 3
- Undergo a blood draw to measure plasma sphingolipids
- Have a CytoCam device take images of small vessels inside their mouth
- 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
- Complete assessments on frailty and physical function
- Complete an exercise test using either a total body recumbent stepper or a bicycle and pedal in a seated position
- Complete a high-intensity interval exercise on a bicycle or an elliptical machine
- Have a CytoCam device take images of small vessels inside their mouth
- 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
- Conditions
- Aging, Fragility, Endothelial Dysfunction
- Being tested
- Ischemic Conditioning
- Keywords
- Vasodilation, Exercise, Fitness
- Medical subject headings
- Aneurysm, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic ConditioningOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic Conditioning-Low | Sham comparator | 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. Receives: Other: Ischemic Conditioning |
| Ischemic Conditioning-High | Experimental | 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. Receives: Other: Ischemic Conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Acetylcholine-mediated dilation
Cutaneous vascular conductance in response to acetylcholine infusion will be calculated as laser Doppler flux / mean arterial pressure
Measured: 2 hours
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%).
Measured: 0.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2023
- Study start2 May 2023
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew J. Durand, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05808686
- Sponsor's protocol ID
- PRO00046569
- Status last verified
- Sep 2025
- First submitted
- 28 Mar 2023
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no current plans to share individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ischemic Conditioning to Promote Microvascular Resiliency in Frail Individuals
- ClinicalTrials.gov ID
- NCT05808686
- Acronym / sponsor ID
- PRO00046569
- Conditions
- Aging, Fragility, Endothelial Dysfunction
- Keywords
- Vasodilation, Exercise, Fitness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 11 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Complete assessments on frailty and physical function
- Complete an exercise test using either a total body recumbent stepper or a bicycle and pedal in a seated position
Study Visit 2
- Undergo a blood draw to measure plasma sphingolipids
- Have a CytoCam device take images of small vessels inside their mouth
- 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
- Complete a high-intensity interval exercise on a bicycle or an elliptical machine
- Have a CytoCam device take images of small vessels inside their mouth
- 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
- Get a handheld sphygmomanometer and a blood pressure cuff to take home.
- 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.
- This intervention will be completed 5 times a day for 2 weeks
Visit 3
- Undergo a blood draw to measure plasma sphingolipids
- Have a CytoCam device take images of small vessels inside their mouth
- 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
- Complete assessments on frailty and physical function
- Complete an exercise test using either a total body recumbent stepper or a bicycle and pedal in a seated position
- Complete a high-intensity interval exercise on a bicycle or an elliptical machine
- Have a CytoCam device take images of small vessels inside their mouth
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ischemic Conditioning-Low | Sham comparator | Other: Ischemic ConditioningWe 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-High | Experimental | Other: Ischemic ConditioningWe 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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Women and men ages 65-85 years of age
Key exclusion criteria (7 listed)
- Myocardial infarction in last 6 months
- morbid obesity (BMI >40)
- heart failure
- uncontrolled hypertension
- other condition that precludes high intensity exercise (ex, neurological disorder, acute systemic infection)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ischemic ConditioningWe 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. | Other | Ischemic Conditioning-High, Ischemic Conditioning-Low |
Primary outcome
Change in Acetylcholine-mediated dilation
Time frame: 2 hours
Cutaneous vascular conductance in response to acetylcholine infusion will be calculated as laser Doppler flux / mean arterial pressure
Change in Perfused Vessel Density
Time frame: 0.5 hours
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%).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No. There are no current plans to share individual participant data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ischemic Conditioning in people with Aging and Fragility, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Nguyen (414-955-1917, jnguyen@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Acetylcholine-mediated dilation (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.