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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
Awards & highlights
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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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Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
610 Previous Clinical Trials
1,162,653 Total Patients Enrolled
3 Trials studying Aging
414 Patients Enrolled for Aging
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had blood clots in my arms or legs.My high blood pressure is not under control.My BMI is over 40.I have had a heart attack in the last 6 months.I have a history of heart failure.I don't have any conditions that prevent arm compression or temporary reduced blood flow.I am between 65 and 85 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Ischemic Conditioning-Low
- Group 2: Ischemic Conditioning-High
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial only open to individuals under 40 or are elder patients eligible?
"Enrollees for this medical research must be between 55 and 85 years old. Additionally, there are 5 trials dedicated to minors and 273 designed specifically for senior citizens."
Answered by AI
What are the eligibility requirements for participating in this medical trial?
"To be admitted into this experiment, participants must fall within the age range of 55 and 85. A maximum of 50 individuals can take part in the trial."
Answered by AI
How many participants are currently being included in this research endeavor?
"Affirmative. According to the data collected on clinicaltrials.gov, this study is presently looking for enrollees and was initially posted on May 2nd of 2023 with subsequent edits occurring a month later. 50 individuals are expected to join from one medical centre."
Answered by AI
Are any new participants being welcomed into this experiment?
"Affirmative. According to the clinicaltrials.gov portal, this investigation has been actively recruiting since May 2nd 2023 and is still looking for 50 participants from a single medical site."
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