NCT02727439

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 4, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 4, 2016

Status Verified

March 1, 2016

Enrollment Period

1.2 years

First QC Date

March 18, 2016

Last Update Submit

March 29, 2016

Conditions

Physical Exertion

Keywords

microvascular functionlaser Doppler flowmetryexercise

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Acetylcholine induced dilation (AChID), recorded by Laser Doppler Flowmetry will be measured immediately after acute exhausting training.

Study Arms (2)

Sedentary Subjects

EXPERIMENTAL

Healthy lean sedentary subjects.

Other: Acute Exhausting Exercise (AE)

Athletes

EXPERIMENTAL

Active athletes.

Other: Acute Exhausting Exercise (AE)

Interventions

Acute Exhausting Exercise (AE)OTHER

A single progressive rowing training to maximal exhaustion (AE).

AthletesSedentary Subjects

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy volunteers
  • active athletes
  • lean sedentary subjects

You may not qualify if:

  • drugs that could affect the endothelium
  • overweight
  • hypertension
  • coronary artery disease
  • diabetes
  • hyperlipidaemia
  • renal impairment
  • cerebrovascular and peripheral artery disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Osijek, Laboratory for Clinical and Sport Physiology

Osijek, 31000, Croatia

RECRUITING

Related Publications (3)

  • 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.

    PMID: 26498129BACKGROUND

  • Cavka 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.

    PMID: 26848993BACKGROUND

  • Phillips 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.

    PMID: 21252216BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Ines Drenjancevic, MD, PhD

    Faculty of Medicine, Josip Juraj Strossmayer University of Osijek

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Stupin, MD, PhD

CONTACT

+385915134958anacavka@mefos.hr

Ines Drenjancevic, MD, PhD

CONTACT

+385912241406ines.drenjancevic@mefos.hr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Dean for Science, Faculty of Medicine Josip Juraj Strossmayer University of Osijek

Study Record Dates

First Submitted

March 18, 2016

First Posted

April 4, 2016

Study Start

February 1, 2016

Primary Completion

May 1, 2017

Study Completion

December 1, 2017

Last Updated

April 4, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

CR(1)