Cardiovascular Disease RiskNCT03624452
Remote Ischaemic Preconditioning Combined With Exercise Training on Vascular Function.
A study testing rIPC + Exercise and rIPC only in people with Cardiovascular Disease Risk, run by Liverpool John Moores University at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiovascular Disease Risk
- What is being tested?
- rIPC + Exercise and rIPC only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jan 2018to 17 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Research Institute for Sport and Exercise Science, Liverpool John Moores Unversity
Liverpool, Merseyside, L3 5AF
About this study
Official title: The Effects of 8 Weeks of Remote Ischaemic Preconditioning Combined With Exercise Training on (Cerebro) Vascular Function.
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.
Read the 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
- Being tested
- rIPC + Exercise, rIPC only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rIPC + ExerciseOther
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 onlyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: rIPC only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in peripheral vascular function
Flow mediated dilation will be used to assess endothelial-dependent vasodilation of the brachial artery.
Measured: 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
Transcranial Doppler will be used to assess the cerebral blood flow response to changes in blood pressure, neural activity and breathing rate.
Measured: 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
Vascular response to an ischemia re-perfusion injury will be assessed in the upper arm using 15 minutes of cuff inflation to 200mmHg followed by 15 minutes of reperfusion. The ability of the brachial artery to vasodilate will be used as a marker of reperfusion injury.
Measured: 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
This will involve assessment of cardiorespiratory fitness using a maximal oxygen uptake test on a treadmill. Participants will be fitted with a heart rate monitor and face mask.
Measured: Cardiorespiratory fitness will be assessed before and after the 8 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start10 Jan 2018
- Primary completion17 Aug 2019
- Study completion17 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Disease RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624452
- Sponsor's protocol ID
- Exericse&rIPC
- Status last verified
- Aug 2019
- First submitted
- 18 Jul 2018
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of 8 Weeks of Remote Ischaemic Preconditioning Combined With Exercise Training on (Cerebro) Vascular Function.
- ClinicalTrials.gov ID
- NCT03624452
- Acronym / sponsor ID
- Exericse&rIPC
- Conditions
- Cardiovascular Disease Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 17 Aug 2019 (actual)
- Study completion
- 17 Aug 2019 (actual)
- First posted
- 10 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rIPC and exercise training | Experimental | Other: rIPC + ExerciseThose 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 |
| rIPC only | Experimental | Other: rIPC onlyThose randomly allocated into the rIPC group will self administer 3 bouts of IPC per week at home at a time of their choice. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rIPC + ExerciseThe 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. | Other | rIPC and exercise training |
| rIPC onlyThree 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. | Other | rIPC only |
Primary outcome
Changes in peripheral vascular function
Time frame: Peripheral vascular function will be assessed before the intervention, after 2 weeks of the intervention and after the end of the 8 week intervention.
Flow mediated dilation will be used to assess endothelial-dependent vasodilation of the brachial artery.
3 secondary outcomes
Detect changes in cerebrovascular function
Time frame: 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
Time frame: 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
Time frame: Cardiorespiratory fitness will be assessed before and after the 8 week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rIPC + Exercise and rIPC only in people with Cardiovascular Disease Risk, run by Liverpool John Moores University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in peripheral vascular function (time frame: Peripheral vascular function will be assessed before the intervention, after 2 weeks of the intervention and after the end of the 8 week intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.