Remote Ischaemic Preconditioning Combined With Exercise Training on Vascular Function.

NCT ID: NCT03624452

Last Updated: 2019-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-10
• Study Completion Date: 2019-08-17

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.

Conditions

Cardiovascular Disease Risk

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

rIPC and exercise training

Those in the rIPC + exercise group will attend three 50 minute exercise sessions per week for 8 weeks at Liverpool John Moores University and 3 bouts of IPC per week at home at a time of their choice

Group Type: EXPERIMENTAL

rIPC + Exercise

Intervention Type: OTHER

The interventions consist of exercise training on a static bike three times per week and/or three bouts of rIPC per week for 8 weeks. A single bout of rIPC consists of cycles of upper arm cuff inflation for 5 minutes, followed by 5 minutes cuff deflation repeated 4 times.

rIPC only

Those randomly allocated into the rIPC group will self administer 3 bouts of IPC per week at home at a time of their choice.

Group Type: EXPERIMENTAL

rIPC only

Intervention Type: OTHER

Three bouts of rIPC per week for 8 weeks. A single bout of rIPC consists of cycles of upper arm cuff inflation for 5 minutes, followed by 5 minutes deflation repeated 4 times.

Interventions

rIPC + Exercise

The interventions consist of exercise training on a static bike three times per week and/or three bouts of rIPC per week for 8 weeks. A single bout of rIPC consists of cycles of upper arm cuff inflation for 5 minutes, followed by 5 minutes cuff deflation repeated 4 times.

Intervention Type: OTHER

rIPC only

Three bouts of rIPC per week for 8 weeks. A single bout of rIPC consists of cycles of upper arm cuff inflation for 5 minutes, followed by 5 minutes deflation repeated 4 times.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Liverpool John Moores University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Institute for Sport and Exercise Science, Liverpool John Moores Unversity

Liverpool, Merseyside, United Kingdom

Countries

United Kingdom

Other Identifiers

Exericse&rIPC

Identifier Type: -

Identifier Source: org_study_id