Physical ExertionNCT02727439
Acute Exercise and Microvascular Function
A study testing Acute Exhausting Exercise (AE) in people with Physical Exertion, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
Trial summary
It is well recognized that chronic exercise protects against the development of cardiovascular diseases. However, the responses of vasculature to acute exercise (AE) are not well known and not consistent in literature. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Exertion
- What is being tested?
- Acute Exhausting Exercise (AE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCroatia
- Study dates
- Feb 2016to Dec 2017
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy volunteers
- active athletes
- lean sedentary subjects
Who cannot join
- drugs that could affect the endothelium
- overweight
- hypertension
- coronary artery disease
- diabetes
- hyperlipidaemia
- renal impairment
- cerebrovascular and peripheral artery disease
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
Faculty of Medicine Osijek, Laboratory for Clinical and Sport Physiology
Osijek, 31000
Ana Stupin, MD, PhD, '385915134598, anacavka@mefos.hr
Ines Drenjancevic, MD, PhD, '385912241406, ines.drenjancevic@mefos.hr
About this study
Official title: Influence of Acute Exhausting Exercise on Microvascular Reactivity in Healthy Sedentary Subjects and Athletes
It is well recognized that chronic exercise protects against the development of cardiovascular diseases. However, the responses of vasculature to acute exercise (AE) are not well known and not consistent in literature. Acute exertional exercise can induce large, transient increases in arterial pressure and development of metabolic acidosis which can be associated with pro-inflammatory response involving oxidant stress and circulating cytokines known to impair endothelial function.
The aim of this study is to test the impact of a single exposure to exhausting training on microvascular reactivity in healthy sedentary subjects and athletes.
- Conditions
- Physical Exertion
- Being tested
- Acute Exhausting Exercise (AE)
- Keywords
- microvascular function, laser Doppler flowmetry, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute Exhausting Exercise (AE)Other
A single progressive rowing training to maximal exhaustion (AE).
| Study group | Role | What they receive |
|---|---|---|
| Sedentary Subjects | Experimental | Healthy lean sedentary subjects. Receives: Other: Acute Exhausting Exercise (AE) |
| Athletes | Experimental | Active athletes. Receives: Other: Acute Exhausting Exercise (AE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin microcirculation post occlusive reactive hyperemia
Cutaneous microvascular blood flow will be measured by Laser Doppler Flowmetry in response to vascular occlusion (post occlusive reactive hyperemia - PORH) before and after acute exhausting training.
Measured: Post occlusive reactive hyperemia - PORH, recorded by Laser Doppler Flowmetry will be measured immediately after acute exhausting training.
Skin microcirculation acetylcholine induced dilation
Cutaneous microvascular blood flow will be measured by Laser Doppler Flowmetry in response to iontophoresis of acetylcholine (acetylcholine induced dilation, AChID) before and after acute exhausting training.
Measured: Acetylcholine induced dilation (AChID), recorded by Laser Doppler Flowmetry will be measured immediately after acute exhausting training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study startFeb 2016
- Primary completionMay 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Physical ExertionStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Josip Juraj Strossmayer University of Osijek
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ines Drenjancevic, Josip Juraj Strossmayer University of Osijek
- Investigators
- Ines Drenjancevic, MD, PhD, Principal investigator, Faculty of Medicine, Josip Juraj Strossmayer University of Osijek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727439
- Sponsor's protocol ID
- 215861071403
- Status last verified
- Mar 2016
- First submitted
- 18 Mar 2016
- Last updated
- 4 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Cavka A, Cosic A, Jukic I, Jelakovic B, Lombard JH, Phillips SA, Seric V, Mihaljevic I, Drenjancevic I. The role of cyclo-oxygenase-1 in high-salt diet-induced microvascular dysfunction in humans. J Physiol. 2015 Dec 15;593(24):5313-24. doi: 10.1113/JP271631. Epub 2015 Dec 7.
PubMed 26498129Cavka A, Jukic I, Ali M, Goslawski M, Bian JT, Wang E, Drenjancevic I, Phillips SA. Short-term high salt intake reduces brachial artery and microvascular function in the absence of changes in blood pressure. J Hypertens. 2016 Apr;34(4):676-84. doi: 10.1097/HJH.0000000000000852.
PubMed 26848993Phillips SA, Das E, Wang J, Pritchard K, Gutterman DD. Resistance and aerobic exercise protects against acute endothelial impairment induced by a single exposure to hypertension during exertion. J Appl Physiol (1985). 2011 Apr;110(4):1013-20. doi: 10.1152/japplphysiol.00438.2010. Epub 2011 Jan 20.
PubMed 21252216
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Acute Exhausting Exercise on Microvascular Reactivity in Healthy Sedentary Subjects and Athletes
- ClinicalTrials.gov ID
- NCT02727439
- Acronym / sponsor ID
- 215861071403
- Conditions
- Physical Exertion
- Keywords
- microvascular function, laser Doppler flowmetry, exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Josip Juraj Strossmayer University of OsijekUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 4 Apr 2016 (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.
It is well recognized that chronic exercise protects against the development of cardiovascular diseases. However, the responses of vasculature to acute exercise (AE) are not well known and not consistent in literature. Acute exertional exercise can induce large, transient increases in arterial pressure and development of metabolic acidosis which can be associated with pro-inflammatory response involving oxidant stress and circulating cytokines known to impair endothelial function.
The aim of this study is to test the impact of a single exposure to exhausting training on microvascular reactivity in healthy sedentary subjects and athletes.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedentary Subjects | Experimental | Other: Acute Exhausting Exercise (AE)Healthy lean sedentary subjects. |
| Athletes | Experimental | Other: Acute Exhausting Exercise (AE)Active athletes. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy volunteers
- active athletes
- lean sedentary subjects
Key exclusion criteria (8 listed)
- drugs that could affect the endothelium
- overweight
- hypertension
- coronary artery disease
- diabetes
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 |
|---|---|---|
| Acute Exhausting Exercise (AE)A single progressive rowing training to maximal exhaustion (AE). | Other | Athletes, Sedentary Subjects |
Primary outcome
Skin microcirculation post occlusive reactive hyperemia
Time frame: Post occlusive reactive hyperemia - PORH, recorded by Laser Doppler Flowmetry will be measured immediately after acute exhausting training.
Cutaneous microvascular blood flow will be measured by Laser Doppler Flowmetry in response to vascular occlusion (post occlusive reactive hyperemia - PORH) before and after acute exhausting training.
Skin microcirculation acetylcholine induced dilation
Time frame: Acetylcholine induced dilation (AChID), recorded by Laser Doppler Flowmetry will be measured immediately after acute exhausting training.
Cutaneous microvascular blood flow will be measured by Laser Doppler Flowmetry in response to iontophoresis of acetylcholine (acetylcholine induced dilation, AChID) before and after acute exhausting training.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2016.
- Background: PubMed 26498129Cavka A, Cosic A, Jukic I, Jelakovic B, Lombard JH, Phillips SA, Seric V, Mihaljevic I, Drenjancevic I. The role of cyclo-oxygenase-1 in high-salt diet-induced microvascular dysfunction in humans. J Physiol. 2015 Dec 15;593(24):5313-24. doi: 10.1113/JP271631. Epub 2015 Dec 7.
- Background: PubMed 26848993Cavka A, Jukic I, Ali M, Goslawski M, Bian JT, Wang E, Drenjancevic I, Phillips SA. Short-term high salt intake reduces brachial artery and microvascular function in the absence of changes in blood pressure. J Hypertens. 2016 Apr;34(4):676-84. doi: 10.1097/HJH.0000000000000852.
- Background: PubMed 21252216Phillips SA, Das E, Wang J, Pritchard K, Gutterman DD. Resistance and aerobic exercise protects against acute endothelial impairment induced by a single exposure to hypertension during exertion. J Appl Physiol (1985). 2011 Apr;110(4):1013-20. doi: 10.1152/japplphysiol.00438.2010. Epub 2011 Jan 20.
- 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.
Ines Drenjancevic, MD, PhD principal investigator
Faculty of Medicine, Josip Juraj Strossmayer University of Osijek
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute Exhausting Exercise (AE) in people with Physical Exertion, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 4 Apr 2016. 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 Croatia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana Stupin, MD, PhD (+385915134958, anacavka@mefos.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin microcirculation post occlusive reactive hyperemia (time frame: Post occlusive reactive hyperemia - PORH, recorded by Laser Doppler Flowmetry will be measured immediately after acute exhausting training.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02727439, which also lists 3 linked publications.
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 4 Apr 2016.