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

Study Results

Results pending

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.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-25

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Remote Ischemic Conditioning on Blood Pressure in Older Patients With Hypertension

NCT05845905

Essential Hypertension

RECRUITING NA

Remote Ischemic Conditioning for the Treatment of Resistant Hypertension

NCT05426707

Resistant Hypertension

UNKNOWN NA

Passive Heat Therapy for Lowering Systolic Blood Pressure and Improving Vascular Function in Mid-life and Older Adults

NCT05300971

Aging

RECRUITING NA

Use of Technology to Optimize Hypertension Treatment in Elderly People in Primary Care

NCT04861727

Systemic Arterial Hypertension Pharmacotherapy Pharmaceutical Care

COMPLETED NA

Efficacy and Safety of Remote Ischemic Conditioning in the Treatment of Essential Hypertension (RICBP-EH)

NCT05910242

Essential Hypertension

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Hypertension and stroke remain leading causes of mortality across the world (1). Hypertension affects more than 1 in 4 adults and is the 3rd biggest risk factor for premature death and disability in the UK (2). Cerebrovascular disease is ranked 4th in the list of leading causes of death in the UK (3). At present, the treatment of these conditions largely involves chronic pharmacotherapy. In parallel, it is increasingly appreciated that polypharmacy poses a significant challenge to our older adult population. Guthrie et al showed that the number of people prescribed \>5 medications in an area of the UK doubled between 1995 and 2010 (from 11.4% to 20.8%) (4). Age is significantly associated with polypharmacy, with an odds ratio of 118.3 when those aged 20-29 are compared to those \>80. What's more, it has been estimated that adverse drug reactions account for 6.5% of hospital admissions (5), with age correlating significantly with admissions for this reason. Therefore, discovering a non-pharmacological intervention for hypertension and cerebrovascular disease could greatly benefit the population, particularly the elderly, both in terms of treating the diseases themselves and reducing the harmful effects of polypharmacy.

Remote ischaemic preconditioning (RIPC) is the induction of non-lethal ischaemia in one organ or tissue, with the aim of conditioning a distant organ or tissue against ischaemic events. It is achieved via inflation of a blood pressure cuff to supra-systolic pressures for a short period of time. A recent meta-analysis showed that chronic RIC, but not acute RIC, significantly lowered diastolic and mean arterial blood pressure (6). The studies included in this review were small and performed in a younger population, hence larger studies are needed to clarify the effect of RIC in the field of hypertension and, importantly, the elderly.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension Vascular Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Participants are blinded to intervention. Assessors measuring outcomes are blinded to participant identity and intervention.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Remote Ischaemic Preconditioning

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.

Group Type ACTIVE_COMPARATOR

Remote Ischaemic Preconditioning

Intervention Type 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.

Sham remote ischaemic preconditioning

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

Group Type SHAM_COMPARATOR

Sham Remote Ischaemic Preconditioning

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Remote Ischaemic Preconditioning

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.

Intervention Type DEVICE

Sham Remote Ischaemic Preconditioning

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes