Remote Ischaemic Conditioning in the Older Person and Effects on Dynamic Cerebral Autoregulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-85
SponsorUniversity of Nottingham
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Active cardiovascular or cerebrovascular disease (acute event within the last 12 months)
Atrial fibrillation or other significant arrhythmias
Peripheral Vascular Disease
Haemostatic disorders
Trial design
Design model
Parallel
Treatments tested in this trial
Remote Ischaemic Conditioning
DeviceCuff 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
DeviceCuff 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
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: High dose RICExperimental treatment 1 intervention
Group B: Low dose RICExperimental treatment 1 intervention
Group C: Sham RICPlacebo comparator 1 intervention
Trial outcomes
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
Time frame
Baseline and 6 weeksSecondary outcomes
1
Phase DIfference
In dynamic cerebral autoregulation analysis, the phase difference quantifies the timing shift between oscillations in arterial blood pressure (ABP) and cerebral blood flow velocity (CBFV) at a given frequency. It is reported in degrees with higher values representing stronger autoregulation
Time frame
Baseline and 6 weeks2
Gain
In dynamic cerebral autoregulation analysis, the Gain quantifies the magnitude of transmission of blood pressure oscillations into cerebral blood flow oscillations. It is reported both as cm/s/mmHg. Lower values represent better autoregulation.
Time frame
Baseline and 6 weeks3
Clinic Systolic Blood Pressure
Resting blood pressure will be calculated using automated sphygmomanometer. The average of 3 recordings will be used. Blood pressure will be rexpressed in units of mmHg.
Time frame
Baseline and week 64
Clinic Diastolic Blood Pressure
Resting blood pressure will be calculated using automated sphygmomanometer. The average of 3 recordings will be used. Blood pressure will be rexpressed in units of mmHg.
Time frame
Baseline to 6 WeeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Nottingham
Lead sponsor
University of Leicester
Collaborator
Source ClinicalTrials.gov