School of Medicine, Royal Derby Hospital Site, University of Nottingham
Derby, Derbyshire, DE22 3DT, United Kingdom
NCT Number: NCT05971407
The purpose of this study is to assess whether remote ischaemic conditioning, applied chronically, improves vascular health in older adults
Looking for future studies?
Notify Me65 year–85 year
All sexes
Interventional
Not applicable
Derby, Derbyshire, DE22 3DT, United Kingdom
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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.
Time frame: Measured at baseline, week 3 and week 6
Changes in blood pressure measured by automated sphygmomanometer over 6 weeks. Measured after participants have rested for 10 minutes in a temperature controlled room.
Time frame: Measured at baseline, week 3 and week 6
Changes in blood pressure measured by automated sphygmomanometer over 6 weeks. Measured after participants have rested for 10 minutes in a temperature controlled room.
Time frame: Measured at baseline, week 3 and week 6
Changes in blood pressure measured by automated sphygmomanometer over 6 weeks. Measured after participants have rested for 10 minutes in a temperature controlled room.
Time frame: Measured at baseline and week 6
Changes in blood pressure measured by 24-hour blood pressure monitor.
Time frame: Measured at baseline and week 6
Changes in blood pressure measured by 24-hour blood pressure monitor.
Time frame: Measured at baseline and week 6
Changes in blood pressure measured by 24-hour blood pressure monitor.
Time frame: Measured at baseline, week 3 and week 6
Flow mediated dilatation is measured by continuous ultrasound imaging of the brachial artery. Brachial artery diameter is measured using edge tracking software for one minute before distal occlusion is applied to the brachial artery for 5 minutes at 230mmHg using and automated vascular assessment pressure cuff. Following release of the distal occlusion, flow mediated dilatation is measured for 4 minutes using edge tracking software
Time frame: Measured at baseline, week 3 and week 6
Pulsewave velocity is measured using carotid and femoral artery transducers. Pulse transit time and the distance between transducers is then used to calculate PWV.
Time frame: Measured at baseline and week 6.
Biomarkers of RIC mechanism will be quantified by ELISA from plasma samples collected before and after intervention.
University of Nottingham
Other
Acronym: RIPCo
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02439775
Cardiovascular Diseases, Hypertension
Huntsville, Alabama, United States
View Trial DetailsNCT03626688
Cardiovascular Diseases, Connective Tissue Diseases
Birmingham, Alabama, United States
View Trial DetailsNCT06069102
Cardiovascular Diseases, Eclampsia
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT05561556
Behavior, Cardiovascular Diseases
Auburn, Alabama, United States
View Trial Details