NCT05808686 Ischemic Conditioning to Promote Microvascular Resiliency in Frail Individuals
| NCT ID | NCT05808686 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Medical College of Wisconsin |
| Condition | Aging |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-05-02 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2023-05-02 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05808686 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, up to 85 Years, studying Aging. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05808686 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05808686 currently recruiting?
Yes, NCT05808686 is actively recruiting participants. Contact the research team at jnguyen@mcw.edu for enrollment information.
Where is the NCT05808686 trial being conducted?
This trial is being conducted at Wauwatosa, United States.
Who is sponsoring the NCT05808686 clinical trial?
NCT05808686 is sponsored by Medical College of Wisconsin. The trial plans to enroll 60 participants.