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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how remote ischemic conditioning (RIC) can improve muscle strength, exercise tolerance, and quality of life for individuals over 65 with mobility challenges. RIC involves temporarily restricting blood flow to a limb, potentially enhancing the benefits of regular exercise. The study includes two groups: one receiving a high dose of RIC and the other a low dose, both combined with low-intensity resistance exercise. Ideal participants are those referred to an exercise program due to balance problems or muscle weakness. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance exercise benefits for seniors.

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 prior data suggests that this technique is safe for individuals with limited mobility?

Studies have shown that remote ischemic conditioning (RIC) is generally safe for people. Research indicates that RIC is well-tolerated by various groups, including those with neurological disorders and children with cerebral palsy, meaning most did not experience serious side effects. Additionally, a study found that combining RIC with exercise was safe for individuals recovering from a stroke.

Overall, these findings suggest that RIC is a promising and safe addition to exercise programs, particularly for older adults with mobility issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Remote Ischemic Conditioning (RIC) for people with limited mobility because it offers a novel approach compared to traditional physical therapy and medications. RIC involves temporarily restricting blood flow to a limb using a cuff, which can trigger beneficial responses throughout the body and potentially enhance muscle strength and endurance without intense physical exertion. This technique is especially promising for individuals who can't engage in regular exercise due to mobility issues, providing a safer and more accessible option. By using both high-dose and low-dose interventions, researchers hope to determine the most effective way to harness these benefits.

What evidence suggests that remote ischemic conditioning is effective for improving mobility?

Research has shown that remote ischemic conditioning (RIC) can improve health outcomes for various conditions. Studies have found that RIC reduces the risk of tissue damage after a stroke and aids in recovery. By temporarily stopping blood flow to an arm or leg, RIC appears to help the body better cope with stress. This trial will compare two doses of RIC: a high-dose intervention and a low-dose intervention. This technique has also shown promise in boosting muscle strength and resilience in other situations. Although specific data on improving mobility in older adults is limited, the mechanism of RIC suggests it could be beneficial. ^{6 7 8 9 10}

Who Is on the Research Team?

W Todd Cade, PhD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6128414/

Remote ischemic conditioning: a promising therapeutic ... (1) Acute ischemic stroke [146,147], RIC treatment after acute stroke was likely to lower the risk of tissue infarction after 1 month, and improve the ...

2. withpower.com withpower.com/trial/phase-mobility-limitation-7-2024-2cdd4

Remote Ischemic Conditioning for Limited Mobility The purpose of this study is to examine the feasibility and acceptability of a technique called remote ischemic conditioning (RIC) that aims to improve ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2451830119319387

Remote ischemic conditioning improves outcome ... Our results indicate that RIC is effective in improving outcome following modeled brain trauma in pre- and post-injury paradigms.

4. academic.oup.com academic.oup.com/eurheartj/advance-article/doi/10.1093/eurheartj/ehaf570/8232488

the SERIC-EVT trial | European Heart Journal | Oxford Academic Remote ischaemic conditioning improves outcomes of ischaemic stroke treated by endovascular thrombectomy: the SERIC-EVT trial Open Access.

5. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.124.046615

Remote Ischemic Conditioning for Acute Ischemic Stroke Results from a previous open-label blinded outcome proof-of-concept trial that included 443 patients with suspected acute stroke demonstrated ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11657452/

Remote ischaemic conditioning for neurological disorders—a ... The comprehensive analysis of the included studies reveals promising results regarding the safety and therapeutic effect of RIC as an option for managing ...

7. systematicreviewsjournal.biomedcentral.com systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-024-02725-8

Remote ischaemic conditioning for neurological disorders—a ... This systematic review examines the clinical evidence, from randomised controlled trials, of the benefits or harms of RIC as an additional therapy.

8. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2022.981498/full

Remote ischemic conditioning (RIC) with exercise (RICE) ... This study assessed the safety and feasibility of the novel rehabilitation strategy—early RIC followed by exercise (RICE) in acute ischemic stroke (AIS).

9. mdpi.com mdpi.com/2227-9067/12/10/1372

Feasibility, Safety, and Tolerability of Remote Ischemic ... Remote ischemic conditioning (RIC) was feasible in children with unilateral cerebral palsy (CP), with excellent recruitment, retention, and full adherence to ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8576053/

Remote Ischemic Conditioning in Ischemic Stroke and ... We report evidence that RIC reduces circulating biomarkers of myocardial necrosis, infarct size, and edema, although this effect appears not to translate into ...