Remote Ischemic Conditioning for Limited Mobility

Overseen By Stephanie Milosovic, DPT

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Unstable heart disease, Orthopaedic, Neurologic, Metabolic, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to examine the feasibility and acceptability of a technique called remote ischemic conditioning (RIC) that aims to improve muscle strength, muscle mass, exercise tolerance, resilience (i.e. how well someone responds to a stressor), quality of life, physical activity, and physical function when added to rehabilitative exercise training in individuals over age 65 who have some difficulty with mobility.

Do I need to stop my current medications for this trial?

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

What data supports the effectiveness of the treatment Remote Ischemic Conditioning (RIC) for limited mobility?

Research suggests that Remote Ischemic Postconditioning (RIPostC), a component of RIC, may protect the brain from damage after a stroke by reducing tissue injury. This protective effect has been observed in studies on brain and kidney injuries, indicating potential benefits for other conditions involving tissue damage. ^{1 2 3 4 5}

Is remote ischemic conditioning safe for humans?

Remote ischemic conditioning (RIC) has been shown to be safe and feasible for patients with acute ischemic stroke, including those undergoing specific treatments like thrombectomy. ^{1 2 4 6 7}

How is remote ischemic conditioning different from other treatments for limited mobility?

Remote ischemic conditioning (RIC) is unique because it involves applying short, repeated periods of reduced blood flow to a limb to protect other parts of the body from damage, unlike traditional treatments that directly target the affected area. This approach is non-invasive and leverages the body's natural protective mechanisms. ^{1 2 3 5 8}

Research Team

W Todd Cade, PhD

Principal Investigator

Duke University

Eligibility Criteria

This trial is for people over 65 who have trouble moving around, possibly due to aging, weakness, or frailty. Participants should be able to perform some low-intensity exercises and must not have conditions that would make the trial unsafe or unsuitable for them.

Inclusion Criteria

I am 65 or older and have been referred to an exercise program because of functional decline, getting weaker, or risk of falling.

Exclusion Criteria

I can follow instructions and safely do exercises.

I don't have any health conditions that prevent me from doing exercise tests.

My heart condition is stable.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo low-intensity resistance exercise training combined with either high-dose or low-dose remote ischemic conditioning (RIC)

6 weeks

Regular visits for exercise sessions

Follow-up

Participants are monitored for changes in muscle strength, physical function, and resilience

1 week

Post-intervention assessment visit

Treatment Details

Interventions

• Remote Ischemic Conditioning (RIC)

Trial Overview The study is testing whether adding remote ischemic conditioning (RIC) to low-intensity resistance exercise can improve muscle strength, mass, exercise tolerance, resilience, quality of life and physical function in older adults with limited mobility.

Participant Groups

Group I: High-Dose RIC (Remote Ischemic Conditioning) Intervention Active Control 2 Interventions

Low-intensity resistance exercise training plus high-dose RIC.

Group II: Low-Dose RIC Intervention Placebo Group 2 Interventions

Low-intensity resistance exercise training plus low-dose RIC.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

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]

Remote ischemic conditioning (RIC) has been shown to significantly reduce the recurrence of ischemic stroke and improve patient prognosis at 90 days, based on a meta-analysis of 6392 patients from 17 randomized controlled trials.

RIC is considered safe, as it does not increase the risk of serious adverse events like death or intracerebral hemorrhage, although it may cause some benign RIC-related adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of remote ischemic conditioning for acute ischemic stroke: A comprehensive meta-analysis from randomized controlled trials. Kan, X., Yan, Z., Wang, F., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

The effect of repeated remote ischemic postconditioning on infarct size in patients with an ischemic stroke (REPOST): study protocol for a randomized clinical trial. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Remote ischemic postconditioning protects the brain from focal ischemia/reperfusion injury by inhibiting autophagy through the mTOR/p70S6K pathway. [2021]

3. Ireland pubmed.ncbi.nlm.nih.gov

Protective effects of three remote ischemic conditioning procedures against renal ischemic/reperfusion injury in rat kidneys: a comparative study. [2018]

4. China pubmed.ncbi.nlm.nih.gov

Remote Ischemic Postconditioning for Ischemic Stroke: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Remote ischemic conditioning for acute ischemic stroke part 2: Study protocol for a randomized controlled trial. [2022]

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

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

7. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of remote ischemic conditioning for acute ischemic stroke: A comprehensive meta-analysis from randomized controlled trials. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Determination of significant parameters in remote ischemic postconditioning for ischemic stroke in experimental models: A systematic review and meta-analysis study. [2022]