Remote Ischemic Conditioning for Healthy Adults

Overseen By Shailesh S Gardas, PT

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: East Carolina University

Disqualifiers: Cognitive deficits, Vision impairment, Balance disorders, Pregnancy, Cardiorespiratory dysfunctions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 5 days

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Remote ischemic conditioning (RIC) is a clinically feasible method that protects distant organs from severe injury through brief, sub lethal periods of ischemia followed by re-perfusion. Recent studies suggest that RIC, combined with training, improves muscle strength and balance in healthy adults and post-stroke survivors. While the underlying mechanisms are not fully understood, RIC's neuroprotective effects - such as promoting angiogenesis, neurogenesis, and modulating glutamate and GABA synthesis - overlap with neuroplasticity processes. Evidence indicates that neuroplasticity from exercise training occurs not only in the cerebral cortex but also within the spinal cord, yet the role of spinal reflex mechanisms underlying the benefits of RIC remains under explored. Therefore, this study aims to investigate effects of RIC on spinal reflex modulation in healthy adults, both independently and combined with balance training.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is remote ischemic conditioning safe for humans?

Remote ischemic conditioning has been shown to be safe and feasible in patients with acute ischemic stroke and those undergoing certain treatments. It is gaining interest for its potential protective effects in various clinical settings, and studies have not reported significant safety concerns. ^{1 2 3 4 5}

How is the treatment Remote Ischemic Conditioning unique for silent ischemia?

Remote Ischemic Conditioning is unique because it involves applying brief, controlled periods of reduced blood flow to a limb, which can help protect the heart by triggering the body's natural protective mechanisms, unlike traditional treatments that focus on medication or surgical procedures. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Remote Ischemic Conditioning for Healthy Adults?

Remote ischemic conditioning has shown potential benefits in other conditions, such as reducing injury in heart and stroke patients by improving blood flow and protecting tissues. While these studies focus on different health issues, they suggest that remote ischemic conditioning might have positive effects on the body. ^{1 2 11 12 13}

Who Is on the Research Team?

Swati M Surkar, PT, PhD

Principal Investigator

East Carolina University

Are You a Good Fit for This Trial?

This trial is for healthy young adults who may have a condition called Ocular Ischemia Syndrome. Participants should be interested in exploring how certain non-invasive treatments can potentially improve muscle strength and balance.

Inclusion Criteria

I am a healthy adult between 18 and 40 years old.

Exclusion Criteria

Individuals who are pregnant

Individuals with balance disorders such as vestibular disorders

I have difficulty seeing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants undergo H-reflex testing and balance assessments

1 day

1 visit (in-person)

Treatment

Participants undergo RIC or sham conditioning combined with balance training over multiple sessions

5 days

5 visits (in-person)

Follow-up

Participants are monitored for changes in H-reflex amplitude and balance performance

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Balance training
• Remote Ischemic Conditioning
• Sham Conditioning

Trial Overview The study tests Remote Ischemic Conditioning (RIC), which involves brief periods of controlled blood flow restriction, followed by restoration. It's being studied alone and with balance training to see if it helps spinal reflexes and improves balance.

How Is the Trial Designed?

Group I: Remote Ischemic Conditioning (RIC) Experimental Treatment 2 Interventions

RIC is achieved via blood pressure cuff inflation to at least 20 mmHg above systolic blood pressure to 250 mmHg on the thigh of dominant LE. RIC involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. RIC is performed on visits 2 - 6.

Group II: Sham conditioning Placebo Group 2 Interventions

Sham conditioning is achieved via blood pressure cuff inflation to 25 mm Hg on the thigh of the dominant LE. Sham involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. Sham conditioning is performed on visits 2-6.

Who Is Running the Clinical Trial?

East Carolina University

Lead Sponsor

Trials

111

Recruited

42,400+

Published Research Related to This Trial

A systematic review of 13 randomized clinical trials involving 7183 patients found that remote ischemic conditioning (RIC) did not significantly reduce mortality rates in acute coronary syndrome (ACS) patients undergoing percutaneous coronary intervention (PCI) over a median follow-up of 1 year.

RIC also showed no significant effect on the incidence of myocardial infarction (MI) or congestive heart failure (CHF), indicating that this intervention may not provide the expected clinical benefits in these patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote Ischemic Conditioning in Patients with Acute Coronary Syndromes: A Systematic Review with Meta-Analysis and Trial Sequential Analysis. Sandven, I., Eritsland, J., Abdelnoor, M.[2022]

Remote ischemic conditioning (RIC) was found to be safe and feasible for 20 patients with acute ischemic stroke undergoing endovascular treatment, with no serious RIC-related adverse events reported during the study.

At the 3-month follow-up, 55% of patients achieved functional independence, suggesting potential benefits of RIC, although further research is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote ischemic conditioning for acute stroke patients treated with thrombectomy. Zhao, W., Che, R., Li, S., et al.[2022]

Citations

1. New Zealand pubmed.ncbi.nlm.nih.gov

Remote Ischemic Conditioning in Patients with Acute Coronary Syndromes: A Systematic Review with Meta-Analysis and Trial Sequential Analysis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Remote ischemic conditioning to protect against ischemia-reperfusion injury: a systematic review and meta-analysis. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Remote Ischemic Conditioning May Improve Disability and Cognition After Acute Ischemic Stroke: A Pilot Randomized Clinical Trial. [2021]

4. Romania pubmed.ncbi.nlm.nih.gov

Remote Ischemic Conditioning in Acute Ischemic Stroke - A Clinical Trial Design. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of remote ischemic conditioning on myocardial perfusion in patients with suspected ischemic coronary artery disease. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Remote ischemic conditioning for acute stroke patients treated with thrombectomy. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Remote ischemic conditioning: evolution of the concept, mechanisms, and clinical application. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Translational challenges of remote ischemic conditioning in ischemic stroke - a systematic review. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Silent ischemia: clinical relevance. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Can we really justify the treatment of silent ischemia in 1992? No! [2020]

11. England pubmed.ncbi.nlm.nih.gov

Current status of silent myocardial ischemia. [2013]

12. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Characteristics of coronary artery lesions in patients with painless myocardial ischemia]. [2017]

13. United States pubmed.ncbi.nlm.nih.gov

Silent ischemia in rehabilitation patients: limited clinical utility of electrocardiographic monitoring. [2007]