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

January 28, 2021 updated by: Prof. Josef Niebauer M.D., Ph.D., MBA, Paracelsus Medical University

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Salzburg, Austria, 5020
        • Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University
      • Salzburg, Austria, 5020
        • Department of Neurology, Christian Doppler Klinik, Paracelsus Medical University Salzburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

healthy participants, wheelchair users

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
October 2017- June 2018
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).
October 2017- June 2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paracelsus Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2017

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

January 28, 2021

Study Registration Dates

First Submitted

November 16, 2017

First Submitted That Met QC Criteria

November 20, 2017

First Posted (Actual)

November 24, 2017

Study Record Updates

Last Update Posted (Actual)

January 29, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UISM-12

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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