Remote Ischaemic Conditioning in the Older Person and Effects on Dynamic Cerebral Autoregulation

NCT07179887 | Recruiting

• 1 other identifier: FMHS 192-0625
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Remote Ischaemic Conditioning (RIC) is the process of inducing short periods of ischaemia in a limb with the aim of improving vascular health systemically. Recent findings have demonsatrated efficacy in a variety of clinical settings. However, the ideal protocol of RIC \[dose\] is unknown. Dynamic Cerebral Autoregulation (dCA) has been shown to increase in response to RIC. 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

Conditions

Cerebral Autoregulation; Blood Pressure; Dynamic Cerebral Autoregulation

Keywords

Remote Ischaemic Conditioning; Dynamic Cerebral Autoregulation; Vascular Health; Randomised Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Autoregulatory Index

  In dynamic cerebral autoregulation analysis, the Autoregulatory Index is a dimensionless index ranging from 0 to 9. 0 represents no autoregulation and 9 represents very strong autoregulation

  Baseline and 6 weeks

Secondary Outcomes (6)

• Phase DIfference

  Baseline and 6 weeks

• Gain

  Baseline and 6 weeks

• Clinic Systolic Blood Pressure

  Baseline and week 6

• Clinic Diastolic Blood Pressure

  Baseline to 6 Weeks

• Clinic Mean Arterial Pressure

  Baseline to 6 Weeks

Study Arms (3)

High dose RIC

EXPERIMENTAL

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

Device: Remote Ischaemic Conditioning

Low dose RIC

EXPERIMENTAL

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

Device: Remote Ischaemic Conditioning

Sham RIC

PLACEBO COMPARATOR

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

Device: Sham Remote Ischaemic Conditioning

Interventions

Remote Ischaemic Conditioning DEVICE

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

High dose RIC; Low dose RIC

Sham Remote Ischaemic Conditioning DEVICE

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

Sham RIC

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study
• Participant aged 65 - 85
• Participant is able to perform RIC independently at home

You may not qualify if:

• Active cardiovascular or cerebrovascular disease (acute event within the last 12 months)
• 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

Sponsors & Collaborators

• University of Nottingham: lead
• University of Leicester: collaborator

Study Sites (1)

School of Medicine, University of Nottingham, Royal Derby Hospital Centre

Derby, Derbyshire, DE22 3DT, United Kingdom

RECRUITING

Related Publications (8)

• 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.

  PMID: 7747156 BACKGROUND

• 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.

  PMID: 9382441 BACKGROUND

• 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.

  PMID: 36354026 BACKGROUND

• 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.

  PMID: 10548297 BACKGROUND

• 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.

  PMID: 35970954 BACKGROUND

• 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.

  PMID: 24203849 BACKGROUND

• 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.

  PMID: 8576366 BACKGROUND

• 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.

  PMID: 8902383 BACKGROUND

Study Officials

• Tim England, MBChB PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harry Keevil, MB BChir

CONTACT

+441332 724676; harry.keevil@nottingham.ac.uk

Tim England, MBChB PhD

CONTACT

+441332724676; Timothy.England@nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Stroke Medicine

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 18, 2025
• Study Start: August 27, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)