Remote Ischaemic Conditioning in the Older Person and Effects on Dynamic Cerebral Autoregulation
NCT ID: NCT07179887
Last Updated: 2025-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
45 participants
INTERVENTIONAL
2025-08-27
2027-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The goal of this trial is to study whether an increase in RIC protocol intensity results in a larger effect on biomarkers of vascular health such as dCA.
Participants shall:
Receive RIC daily, RIC thrice weekly or sham RIC thrice weekly for 6 weeks Visit the School of Medicine at baseline and at 6 weeks for measurement of biomarkers of vascular health including blood pressure, indices od dCA and blood plasma samples
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of RLIC on Motor Learning in Middle-aged and Older Adults
NCT03582943
Remote Ischemic Limb Preconditioning In Healthy Volunteers
NCT02553655
Remote Ischemic Conditioning for Motor Recovery After Acute Ischemic Stroke
NCT05263531
Rheo-Erythrocrine Dysfunction as a Biomarker for RIC Treatment in Acute Ischemic Stroke
NCT04266639
Safety and Efficacy of Remote Ischemic Conditioning in Patients With Acute Ischemic Stroke
NCT03669653
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Preclinical work in animal models of stroke demonstrated consistent benefits of RIC. However, translation of these findings to human trials has yielded mixed results. Two large randomised controlled trials conducted in recent years have suggested benefit where RIC is given as a treatment following acute ischaemic stroke or when used in the secondary prevention of stroke in patients with symptomatic intracranial atherosclerosis. However, other clinical trials of RIC have yielded neutral results. For example, the RESIST trial, which used RIC as an intervention following both acute ischaemic and haemorrhagic stroke.
It is not known exactly why the promising findings in preclinical studies have not been replicated in human trials. It is likely that protocols of RIC, i.e. the 'dose', which proved effective in animal models of stroke, may not be sufficient when applied to multimorbid human populations who have also received current standard therapy. These therapies, such as antiplatelets, themselves provide cerebrovascular protection and may abrogate some of the benefit of RIC. It may be that more intense protocols of RIC, particularly chronic RIC, are needed to illicit benefit in humans.
To answer this question, work should be done to investigate the effect of RIC protocol intensity on vascular health in older adults. Too often in RIC research, there has been a rapid jump from preclinical study to large RCT. These RCTs initially used protocols of RIC based on those used in preclinical studies. With increasing awareness of the potential problems with this approach, RCTs now tend to use more intense protocols of RIC. However, very little work has been done examining the effect of RIC on biomarkers of vascular health to inform the choice of RIC dose, informing future trial design.
Dynamic cerebral autoregulation (dCA) is a measure of the regulation of cerebral blood flow in response to changes in systemic blood pressure. It has been shown to be impaired in the immediate post stroke period (≈2 weeks) and severely impaired autoregulation in the hours after stroke has been correlated with worse outcomes. Dynamic Cerebral Autoregulation has also been shown to improve in young adults given 2 weeks of RIC. We propose to conduct a further study in older adults, aged 65-85, investigating the effect of chronic RIC on biomarkers of vascular health including dCA and blood pressure (BP), comparing two difference dosing regimens.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
High dose RIC
Daily sessions of RIC for 6 weeks. Each session will consist of 4 x 5 minute cuff inflation to 20mmHg above systolic blood pressure, interspersed with 5 minute periods of cuff deflation
Remote Ischaemic Conditioning
Cuff inflation to 20mmHg abocve systolic blood pressure for cycles of 5 minutes. Each session will consist of 4 cycles of 5 minte inflation followed by 5 minute deflation. Total session time 40 minutes
Low dose RIC
3x weekly sessions of RIC for 6 weeks. Each session will consist of 4 x 5 minute cuff inflation to 20mmHg above systolic blood pressure, interspersed with 5 minute periods of cuff deflation
Remote Ischaemic Conditioning
Cuff inflation to 20mmHg abocve systolic blood pressure for cycles of 5 minutes. Each session will consist of 4 cycles of 5 minte inflation followed by 5 minute deflation. Total session time 40 minutes
Sham RIC
3x weekly sessions of Sham RIC for 6 weeks. Each session will consist of 4 x 5 minute cuff inflation to 20mmHg only, interspersed with 5 minute periods of cuff deflation
Sham Remote Ischaemic Conditioning
Cuff inlfation to 20mmHg only for cycles of 5 minutes. Each session will consist of 4 cycles of 5 minute inflation followed by 5 minutes of deflation. Total session time of 40 minutes
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Remote Ischaemic Conditioning
Cuff inflation to 20mmHg abocve systolic blood pressure for cycles of 5 minutes. Each session will consist of 4 cycles of 5 minte inflation followed by 5 minute deflation. Total session time 40 minutes
Sham Remote Ischaemic Conditioning
Cuff inlfation to 20mmHg only for cycles of 5 minutes. Each session will consist of 4 cycles of 5 minute inflation followed by 5 minutes of deflation. Total session time of 40 minutes
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Participant aged 65 - 85
* Participant is able to perform RIC independently at home
Exclusion Criteria
* Atrial fibrillation or other significant arrhythmias
* Peripheral Vascular Disease
* Haemostatic disorders
* Soft tissue injury or fracture to the upper limb
* Pregnant or breast feeding
* History or current psychiatric illness
* History or current neurological condition (e.g. epilepsy)
* Inability to identify temporal window for transcranial doppler ultrasound at screening visit
* Any condition or presentation under current investigation that is deemed by the study clinician to exclude the participant from the study.
* Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance
65 Years
85 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Leicester
OTHER
University of Nottingham
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Timothy England
Professor of Stroke Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tim England, MBChB PhD
Role: PRINCIPAL_INVESTIGATOR
University of Nottingham
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
School of Medicine, University of Nottingham, Royal Derby Hospital Centre
Derby, Derbyshire, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
de Bruijn WC, Boeve ER, van Run PR, van Miert PP, Romijn JC, Verkoelen CF, Cao LC, Schroder FH. Etiology of experimental calcium oxalate monohydrate nephrolithiasis in rats. Scanning Microsc. 1994;8(3):541-9; discussion 549-50.
Craft AW. Challenges in the management of bone tumors--1996. Ann N Y Acad Sci. 1997 Sep 17;824:167-79. doi: 10.1111/j.1749-6632.1997.tb46219.x. No abstract available.
Hou C, Lan J, Lin Y, Song H, Wang Y, Zhao W, Li S, Meng R, Hao J, Ding Y, Chimowitz MI, Fisher M, Hess DC, Liebeskind DS, Hausenloy DJ, Huang J, Li Z, Han X, Yang J, Zhou J, Chen P, Zhu X, Hu P, Pang H, Chen W, Chen H, Li G, Tao D, Yue W, Gao Z, Ji X; RICA investigators. Chronic remote ischaemic conditioning in patients with symptomatic intracranial atherosclerotic stenosis (the RICA trial): a multicentre, randomised, double-blind sham-controlled trial in China. Lancet Neurol. 2022 Dec;21(12):1089-1098. doi: 10.1016/S1474-4422(22)00335-0. Epub 2022 Oct 27.
Benedict MQ, McNitt LM, Cornel AJ, Collins FH. A new marker, black, a useful recombination suppressor, In(2)2, and a balanced lethal for chromosome 2 of the mosquito Anopheles gambiae. Am J Trop Med Hyg. 1999 Oct;61(4):618-24. doi: 10.4269/ajtmh.1999.61.618.
Bell RM, Basalay M, Botker HE, Beikoghli Kalkhoran S, Carr RD, Cunningham J, Davidson SM, England TJ, Giesz S, Ghosh AK, Golforoush P, Gourine AV, Hausenloy DJ, Heusch G, Ibanez B, Kleinbongard P, Lecour S, Lukhna K, Ntsekhe M, Ovize M, Salama AD, Vilahur G, Walker JM, Yellon DM. Remote ischaemic conditioning: defining critical criteria for success-report from the 11th Hatter Cardiovascular Workshop. Basic Res Cardiol. 2022 Aug 15;117(1):39. doi: 10.1007/s00395-022-00947-2.
Hougaard KD, Hjort N, Zeidler D, Sorensen L, Norgaard A, Hansen TM, von Weitzel-Mudersbach P, Simonsen CZ, Damgaard D, Gottrup H, Svendsen K, Rasmussen PV, Ribe LR, Mikkelsen IK, Nagenthiraja K, Cho TH, Redington AN, Botker HE, Ostergaard L, Mouridsen K, Andersen G. Remote ischemic perconditioning as an adjunct therapy to thrombolysis in patients with acute ischemic stroke: a randomized trial. Stroke. 2014 Jan;45(1):159-67. doi: 10.1161/STROKEAHA.113.001346. Epub 2013 Nov 7.
Beighton D, Ludford R, Clark DT, Brailsford SR, Pankhurst CL, Tinsley GF, Fiske J, Lewis D, Daly B, Khalifa N, et al. Use of CHROMagar Candida medium for isolation of yeasts from dental samples. J Clin Microbiol. 1995 Nov;33(11):3025-7. doi: 10.1128/jcm.33.11.3025-3027.1995.
Beilman GJ, Cerra FB. The future. Monitoring cellular energetics. Crit Care Clin. 1996 Oct;12(4):1031-42. doi: 10.1016/s0749-0704(05)70291-8.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FMHS 192-0625
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.