The Effect of Chronic Remote Ischaemic Preconditioning on Blood Pressure in Older Adults

NCT05971407 | Completed DMC

• 1 other identifier: FMHS 34-0722
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess whether remote ischaemic conditioning, applied chronically, improves vascular health in older adults

Conditions

Hypertension; Vascular Diseases

Keywords

Remote Ischaemic Preconditioning; Non-pharmacological; Remote Ischaemic Conditioning; Randomised Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Clinic systolic blood pressure

  Changes in blood pressure measured by automated sphygmomanometer over 6 weeks. Measured after participants have rested for 10 minutes in a temperature controlled room.

  Measured at baseline, week 3 and week 6

Secondary Outcomes (8)

• Clinic diastolic blood pressure

  Measured at baseline, week 3 and week 6

• Clinic Mean arterial pressure

  Measured at baseline, week 3 and week 6

• 24-hour systolic blood pressure

  Measured at baseline and week 6

• 24-hour diastolic blood pressure

  Measured at baseline and week 6

• 24-hour mean arterial pressure

  Measured at baseline and week 6

Study Arms (2)

Remote Ischaemic Preconditioning

ACTIVE COMPARATOR

RIPC is induced by 4 cycles of 5 minutes of healthy upper limb ischaemia followed by 5 minutes reperfusion. Ischaemia is induced by inflation of a blood pressure cuff to 20mmHg above systolic blood pressure. RIPC is conducted 3 times weekly for 6-weeks.

Device: Remote Ischaemic Preconditioning

Sham remote ischaemic preconditioning

SHAM COMPARATOR

Sham RIPC is induced by 4 cycles of 5 minutes of healthy upper limb ischaemia followed by 5 minutes reperfusion. Ischaemia is induced by inflation of a blood pressure cuff to 20mmHg. RIPC is conducted 3 times weekly for 6-weeks

Device: Sham Remote Ischaemic Preconditioning

Interventions

Remote Ischaemic Preconditioning DEVICE

RIPC is induced by 4 cycles of 5 minutes of healthy upper limb ischaemia followed by 5 minutes reperfusion. Ischaemia is induced by inflation of a blood pressure cuff to 20mmHg above systolic blood pressure. RIPC is conducted 3 times weekly for 6-weeks. Clinic blood pressure is measured at weeks 0, 3 and 6. 24-hour blood pressure is measured at weeks 0 and 6.

Remote Ischaemic Preconditioning

Sham Remote Ischaemic Preconditioning DEVICE

Sham RIPC is induced by 4 cycles of 5 minutes of healthy upper limb ischaemia followed by 5 minutes reperfusion. Ischaemia is induced by inflation of a blood pressure cuff to 20mmHg. RIPC is conducted 3 times weekly for 6-weeks. Clinic blood pressure is measured at weeks 0, 3 and 6. 24-hour blood pressure is measured at weeks 0 and 6.

Sham remote ischaemic preconditioning

Eligibility Criteria

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

You may qualify if:

• Participant is aged \>65y and \<85y.
• Participant is willing and able to give informed consent for participation in the study.
• Participant is physically able to perform RIPC.

You may not qualify if:

• A BMI \<18 or \>35 kg/m2
• Active cardiovascular, cerebrovascular or respiratory disease: e.g. uncontrolled hypertension (BP \> 160/100), active angina, heart failure (class III/IV), arrhythmia, right to left cardiac shunt, recent cardiac event, COPD, pulmonary hypertension or recent (6 mo) stroke.
• If history of hypertension, no recent alteration to antihypertensive medication (3 months).
• A history of, or current neurological or musculoskeletal conditions (e.g. epilepsy)
• 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

Study Sites (1)

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

Derby, Derbyshire, DE22 3DT, United Kingdom

Location

Related Publications (6)

• Virani SS, Alonso A, Aparicio HJ, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Cheng S, Delling FN, Elkind MSV, Evenson KR, Ferguson JF, Gupta DK, Khan SS, Kissela BM, Knutson KL, Lee CD, Lewis TT, Liu J, Loop MS, Lutsey PL, Ma J, Mackey J, Martin SS, Matchar DB, Mussolino ME, Navaneethan SD, Perak AM, Roth GA, Samad Z, Satou GM, Schroeder EB, Shah SH, Shay CM, Stokes A, VanWagner LB, Wang NY, Tsao CW; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2021 Update: A Report From the American Heart Association. Circulation. 2021 Feb 23;143(8):e254-e743. doi: 10.1161/CIR.0000000000000950. Epub 2021 Jan 27.

  PMID: 33501848 BACKGROUND

• Health matters: combating high blood pressure: Public Health England; 2017

  BACKGROUND

• https://www.stroke.org.uk/what-is-stroke/stroke-statistics

  BACKGROUND

• Guthrie B, Makubate B, Hernandez-Santiago V, Dreischulte T. The rising tide of polypharmacy and drug-drug interactions: population database analysis 1995-2010. BMC Med. 2015 Apr 7;13:74. doi: 10.1186/s12916-015-0322-7.

  PMID: 25889849 BACKGROUND

• Pirmohamed M, James S, Meakin S, Green C, Scott AK, Walley TJ, Farrar K, Park BK, Breckenridge AM. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ. 2004 Jul 3;329(7456):15-9. doi: 10.1136/bmj.329.7456.15.

  PMID: 15231615 BACKGROUND

• Baffour-Awuah B, Dieberg G, Pearson MJ, Smart NA. The effect of remote ischaemic conditioning on blood pressure response: A systematic review and meta-analysis. Int J Cardiol Hypertens. 2021 Feb 23;8:100081. doi: 10.1016/j.ijchy.2021.100081. eCollection 2021 Mar.

  PMID: 33748739 BACKGROUND

MeSH Terms

Conditions

Hypertension; Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Timothy England, MB ChB PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

• Bethan Phillips, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants are blinded to intervention. Assessors measuring outcomes are blinded to participant identity and intervention.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants complete a 6-week intervention period during which the participants receive either RIPC or sham. There is then a 6-week washout period, after which participants complete the other intervention

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: August 2, 2023
• Study Start: September 25, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)