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Ischemic Conditioning for Frailty

Phase 2

Recruiting

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0.5 hours

Summary

This trial looks at how small blood vessels respond to exercise and if a safe intervention can protect them. Participants will come in for 3 visits and do home-based ischemic conditioning.

Who is the study for?

This trial is for men and women aged 65-85 who may be experiencing frailty or have poor blood vessel function. Participants should be able to perform high-intensity exercise and commit to three study visits along with home-based treatments using a blood pressure cuff.

What is being tested?

The trial tests ischemic conditioning, which involves temporarily restricting blood flow with a cuff, to see if it can protect small blood vessels from stress during high-intensity exercise in older adults.

What are the potential side effects?

Potential side effects of ischemic conditioning could include discomfort or bruising where the cuff is applied, temporary numbness, tingling in the arm, or muscle fatigue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0.5 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0.5 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0.5 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Acetylcholine-mediated dilation

Change in Perfused Vessel Density

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Ischemic Conditioning-HighExperimental Treatment1 Intervention

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.

Group II: Ischemic Conditioning-LowPlacebo Group1 Intervention

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.

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