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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03352505
Other study ID # UISM-12
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2017
Est. completion date January 28, 2021

Study information

Verified date January 2021
Source Paracelsus Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date January 28, 2021
Est. primary completion date October 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Locations

Country Name City State
Austria Department of Neurology, Christian Doppler Klinik, Paracelsus Medical University Salzburg Salzburg
Austria Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University Salzburg

Sponsors (1)

Lead Sponsor Collaborator
Paracelsus Medical University

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary comparison of cardiovascular risk factors between different study groups measurement for arterial stiffness parameters, via pulse wave analysis. Comparison between healthy individuals and patients using wheelchairs (three different groups). October 2017- June 2018
Primary Evaluation of echocardiography results between different study groups Evaluation of echocardiography comparing healthy individuals and patients using wheelchairs (three different groups). October 2017- June 2018
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