Clinical trial NCT03624452: Remote Ischaemic Preconditioning Combined With Exercise Training on Vascular Function.
Official title: The Effects of 8 Weeks of Remote Ischaemic Preconditioning Combined With Exercise Training on (Cerebro) Vascular Function.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease Risk
Lead sponsor: Liverpool John Moores University
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Remote Ischaemic preconditioning' (RIPC) is defined as short controlled sequences of repeated inflation of a blood pressure cuff on the upper arm (to reduce blood flow) for 5 mins followed by recovery (cuff deflation so blood flows normally again). An intervention consisting of 4 cycles of 5 min of arm cuff inflation followed by deflation performed 3 times per week, spread over 8 weeks has been shown to improve blood vessel function in young individuals without any medical conditions. This is a simple and easily applicable intervention that could help the blood vessels capacity to deliver blood to an organ (e.g. heart or the muscle).It is currently unknown if RIPC combined with exercise training, provides stronger benefits to our blood vessels than RIPC alone. Therefore, the aim of this study is to investigate if combining RIPC with an 8 week exercise training programme improves blood vessel health more than 8 weeks of RIPC alone.

Detailed description: A bout of ischaemia using a blood pressure cuff on the upper arm inflated to a pressure of 220 mm Hg for 5 mins followed by reperfusion (deflation of the cuff) is commonly known as remote ischaemic preconditioning (RIPC). Traditionally, RIPC refers to 5 minutes of inflation-5 minutes deflation repeated 4 times. Recent research has investigated the impact of repeated RIPC interventions on cardiovascular health. One previous repeated RIPC intervention, whereby RIPC was performed 3 times per week for eight weeks, identified that RIPC significantly enhanced conduit artery endothelial function and microvascular function.

Exercise training is crucial for a healthy lifestyle, with the World Health Organization recommending that adults aged 18-64 should do at least 150 minutes of moderate aerobic physical activity per week, or at least 75 minutes of vigorous intensity activity. Interestingly, the impact of exercise training on the vasculature is similar to that of repeated RIPC interventions, with reductions in arterial blood pressure, increased in blood flow and improvements in systemic vascular endothelial function. No study has examined if combining exercise and RIPC provides enhanced effects on the vasculature compared to exercise alone.

The aim of this study is to investigate whether combining 8 weeks of exercise and RIPC is more beneficial to systemic vascular function that exercise alone.

Eligibility criteria: Inclusion Criteria:

* Able to provide written consent.
* Males and females 18 to 65 years.
* Body Mass Index \>30g/m2 or waist circumference of ≥94cm (male), ≥80cm (female).
* Raised blood pressure systolic \>130 or diastolic \>85 mmHg or normal
* Diagnosed with high cholesterol by GP or normal

Exclusion Criteria:

* Type 1 or 2 diabetes mellitus
* Previous myocardial infarction, stroke (including TIA) or thrombosis
* Diagnosed with Congestive Heart failure
* Unable to enroll for the duration of the study
* Pregnancy or lactation period
* Smoking
* Any arm injury that will prevent application of the RIPC-intervention

Primary outcomes:
measure: Changes in peripheral vascular function
timeFrame: Peripheral vascular function will be assessed before the intervention, after 2 weeks of the intervention and after the end of the 8 week intervention.
Secondary outcomes:
measure: Detect changes in cerebrovascular function
timeFrame: Cerebrovascular function will be assessed before the intervention, after 2 weeks of the intervention and after the end of the 8 week intervention.
measure: Response to an ischemia re-perfusion injury
timeFrame: Assessments will be performed before the intervention, after 2 weeks of the intervention and after the end of the 8 week intervention.
measure: Assessment of cardiorespiratory fitness
timeFrame: Cardiorespiratory fitness will be assessed before and after the 8 week intervention
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Research Institute for Sport and Exercise Science, Liverpool John Moores Unversity
state: Merseyside
Study officials:
References: