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

Cardiovascular Risk Factor Clinical Trial

Official title:

Associations Between the Cardiovascular Risk Markers and Neuroplasticity in Sedentary or Physically Active Spinal Cord Injured Subjects of the Wheelchair Dancer Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03352505
• Other study ID #: UISM-12
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Cardiovascular Risk Factor
• SCI - Spinal Cord Injury
• Spinal Cord Injuries

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