Recruiting
Phase 2

Ischemic Conditioning

Sponsor:

Medical College of Wisconsin

Code:

NCT05808686

Conditions

Aging

Fragility

Endothelial Dysfunction

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Accepted

Interventions

Ischemic Conditioning

Study Details

Brief 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.

Conditions

Aging

Fragility

Endothelial Dysfunction

Study ID

NCT05808686

Start date

May 2, 2023

Status verified date

Sep, 2025

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Women and men ages 65-85 years of age

Exclusion Criteria:

  • 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).

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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.

Interventions

Ischemic 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.

Primary outcome measure

  • Change in Acetylcholine-mediated dilation [ Time Frame: 2 hours ]
  • Change in Perfused Vessel Density [ Time Frame: 0.5 hours ]

Central Contacts and Locations

Central contacts

Jennifer Nguyen

414-955-1917jnguyen@mcw.edu

Matt Durand

4149555619mdurand@mcw.edu

Locations

Froedtert Hospital

Recruiting

Wauwatosa, Wisconsin, United States, 53226

Contacts

Jennifer Nguyen

414-955-1917jnguyen@mcw.edu

Principal Investigator:

Matt Durand, PhD

More Information

Sponsor

Medical College of Wisconsin

Last update posted

Sep 23, 2025

Last verified

Sep, 2025

Keywords

  • Vasodilation
  • Exercise
  • Fitness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Medical College of Wisconsin on 2025-09-23.