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

Sponsor

Paracelsus Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT03352505

Collaborator

(none)

Enrollment

Locations

39.9

Actual Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
SCI - Spinal Cord Injury Cardiovascular Risk Factor

Study Design

Study Type:

Observational

Actual Enrollment :

54 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 :

Oct 1, 2017

Actual Primary Completion Date :

Oct 1, 2019

Actual Study Completion Date :

Jan 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

comparison of cardiovascular risk factors between different study groups [October 2017- June 2018]
measurement for arterial stiffness parameters, via pulse wave analysis. Comparison between healthy individuals and patients using wheelchairs (three different groups).
Evaluation of echocardiography results between different study groups [October 2017- June 2018]
Evaluation of echocardiography comparing healthy individuals and patients using wheelchairs (three different groups).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Neurology, Christian Doppler Klinik, Paracelsus Medical University Salzburg	Salzburg		Austria	5020
2	Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University	Salzburg		Austria	5020

Sponsors and Collaborators

Paracelsus Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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

Other Study ID Numbers:

UISM-12

First Posted:

Nov 24, 2017

Last Update Posted:

Jan 29, 2021

Last Verified:

Jan 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Spinal Cord Injuries

Study Results

No Results Posted as of Jan 29, 2021