Remote Ischaemic Preconditioning Combined With Exercise Training on Vascular Function.

NCT03624452 | Completed

• 1 other identifier: Exericse&rIPC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Disease Risk

Outcome Measures

Primary Outcomes (1)

• Changes in peripheral vascular function

  Flow mediated dilation will be used to assess endothelial-dependent vasodilation of the brachial artery.

  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 (3)

• Detect changes in cerebrovascular function

  Cerebrovascular function will be assessed before the intervention, after 2 weeks of the intervention and after the end of the 8 week intervention.

• Response to an ischemia re-perfusion injury

  Assessments will be performed before the intervention, after 2 weeks of the intervention and after the end of the 8 week intervention.

• Assessment of cardiorespiratory fitness

  Cardiorespiratory fitness will be assessed before and after the 8 week intervention

Study Arms (2)

rIPC and exercise training

EXPERIMENTAL

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

Other: rIPC + Exercise

rIPC only

EXPERIMENTAL

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

Other: rIPC only

Interventions

rIPC + Exercise 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 and exercise training

rIPC only 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.

rIPC only

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Liverpool John Moores University: lead

Study Sites (1)

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

Liverpool, Merseyside, L3 5AF, United Kingdom

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: August 10, 2018
• Study Start: January 10, 2018
• Primary Completion: August 17, 2019
• Study Completion: August 17, 2019
• Last Updated: August 21, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)