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Cardiovascular Risk Markers in Spinal Cord Injured Subjects of the Wheelchair Dancer Study

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ClinicalTrials.gov Identifier: NCT03352505
Recruitment Status : Recruiting
First Posted : November 24, 2017
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Josef Niebauer M.D., Ph.D., MBA, Paracelsus Medical University

Brief Summary:

The present study will analyze if exercise is able to elicit the well-known anti-atherogenic effects in patients with SCI. This will be evaluated by measuring vascular parameters such as endothelial and inflammatory blood markers, echocardiography of the heart and peripheral vessels, as well as blood pressure and arterial stiffness, in subjects performing either wheelchair dancing, wheelchair marathon or no sports. Further, it will be investigated, whether there is an association between neuroplasticity and cardiovascular health, as measured by electroencephalography (EEG), transcranial magnetic stimulation (TMS) and blood levels of the brain-derived neurotrophic factor (BDNF).

We hypothesize that the cardiovascular, physical and psychological benefits of wheelchair dancing and/or wheelchair marathon parallel improved neuroplasticity in SCI-patients


Condition or disease
SCI - Spinal Cord Injury Cardiovascular Risk Factor

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Associations Between the Cardiovascular Risk Markers and Neuroplasticity in Sedentary or Physically Active Spinal Cord Injured Subjects of the Wheelchair Dancer Study
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : February 2020

Group/Cohort
control
healthy walking control participants
wheelchair dancer
wheelchair users, who are performing wheelchair dancing
wheelchair marathon participants
wheelchair users, who are participants in wheelchair/ handbike Marathon competitions
sedentary wheelchair patients
wheelchair users, who conduct exercise bouts less than 2 times per month



Primary Outcome Measures :
  1. comparison of cardiovascular risk factors between different study groups [ Time Frame: October 2017- June 2018 ]
    measurement for arterial stiffness parameters, via pulse wave analysis. Comparison between healthy individuals and patients using wheelchairs (three different groups).

  2. Evaluation of echocardiography results between different study groups [ Time Frame: October 2017- June 2018 ]
    Evaluation of echocardiography comparing healthy individuals and patients using wheelchairs (three different groups).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
healthy participants, wheelchair users
Criteria

Inclusion Criteria:

wheelchair users independent of the cause of the walking impairment, preferably with spinal cord injury.

Exclusion Criteria:

metallic implanters, additional neurologic pathologies, pregnancy


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03352505


Contacts
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Contact: Josef Niebauer, Prof +43(0) 5 7255-23200 j.niebauer@salk.at

Locations
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Austria
Department of Neurology, Christian Doppler Klinik, Paracelsus Medical University Salzburg Recruiting
Salzburg, Austria, 5020
Contact: Vanessa Frey, MSc    004357255-56812    v.frey@salk.at   
Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University Recruiting
Salzburg, Austria, 5020
Contact: Prof. Josef Niebauer, MD, PhD, MBA    00435725523200 ext 4270    j.niebauer@salk.at   
Sponsors and Collaborators
Paracelsus Medical University

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Responsible Party: Prof. Josef Niebauer M.D., Ph.D., MBA, Prof. Josef Niebauer, M.D., Ph.D, MBA, Paracelsus Medical University
ClinicalTrials.gov Identifier: NCT03352505     History of Changes
Other Study ID Numbers: UISM-12
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries