ExerciseNCT01774461
Ischemic Preconditioning in Endurance Athletes
A study testing Remote ischemic preconditioning in people with Exercise, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
The aim of this study is to investigate the effect of remote ischemic preconditioning on biochemical and functional indices of cardiac function induced by a 30 km run in healthy trained long distance runners. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise
- What is being tested?
- Remote ischemic preconditioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2013to Sep 2013
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent
- Healthy
- Age between 18 and 65 years
- Endurance-trained (two or more training sessions per week)
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Remote Ischemic Preconditioning on Cardiac Function After Endurance Exercise
The aim of this study is to investigate the effect of remote ischemic preconditioning on biochemical and functional indices of cardiac function induced by a 30 km run in healthy trained long distance runners.
- Conditions
- Exercise
- Being tested
- Remote ischemic preconditioning
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic preconditioningOther
Blood pressure cuff placed on upper arm and inflated to 200mmHg for 5 minutes then deflated for 5 minutes - this cycle is repeated a total of 4 times.
| Study group | Role | What they receive |
|---|---|---|
| Sham RIC | No intervention | Control treatment (sham RIC) will consist of four 5-minute simulated inflations of a blood pressure cuff placed on the upper arm. The inflations will be separated by 5-minute periods when the blood pressure cuff will be deflated. |
| Remote ischemic conditioning | Active comparator | Blood pressure cuff placed on upper arm and inflated to 200mmHg for 5 minutes then deflated for 5 minutes - this cycle is repeated a total of 4 times. Receives: Other: Remote ischemic preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentrations of cardiac troponins
Measured: 6 hours, 2 hourly time intervals
Secondary outcomes (1)
Indices of cardiac function measured by echocardiography
Measured: 2 hours post-exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startMar 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marja van Dieijen-Visser, PhD, Principal investigator, Department of Clinical Chemistry, MUMC, Maastricht, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01774461
- Sponsor's protocol ID
- METC12-2-038
- Status last verified
- Mar 2014
- First submitted
- 9 Jul 2012
- Last updated
- 19 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Remote Ischemic Preconditioning on Cardiac Function After Endurance Exercise
- ClinicalTrials.gov ID
- NCT01774461
- Acronym / sponsor ID
- METC12-2-038
- Conditions
- Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 24 Jan 2013 (estimated)
- 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.
The aim of this study is to investigate the effect of remote ischemic preconditioning on biochemical and functional indices of cardiac function induced by a 30 km run in healthy trained long distance runners.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham RIC | No intervention | –Control treatment (sham RIC) will consist of four 5-minute simulated inflations of a blood pressure cuff placed on the upper arm. The inflations will be separated by 5-minute periods when the blood pressure cuff will be deflated. |
| Remote ischemic conditioning | Active comparator | Other: Remote ischemic preconditioningBlood pressure cuff placed on upper arm and inflated to 200mmHg for 5 minutes then deflated for 5 minutes - this cycle is repeated a total of 4 times. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent
- Healthy
- Age between 18 and 65 years
- Endurance-trained (two or more training sessions per week)
Key exclusion criteria (1 listed)
- Not applicable
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 |
|---|---|---|
| Remote ischemic preconditioningBlood pressure cuff placed on upper arm and inflated to 200mmHg for 5 minutes then deflated for 5 minutes - this cycle is repeated a total of 4 times. | Other | Remote ischemic conditioning |
Primary outcome
Serum concentrations of cardiac troponins
Time frame: 6 hours, 2 hourly time intervals
1 secondary outcome
Indices of cardiac function measured by echocardiography
Time frame: 2 hours post-exercise
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 19 Mar 2014.
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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.
Marja van Dieijen-Visser, PhD principal investigator
Department of Clinical Chemistry, MUMC, Maastricht, the Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic preconditioning in people with Exercise, run by Maastricht University Medical Center at 1 site in Netherlands.
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 4 inclusion and 1 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 19 Mar 2014. 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 Netherlands. 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?
Serum concentrations of cardiac troponins (time frame: 6 hours, 2 hourly time intervals). 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 19 Mar 2014.