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CompletedNCT03352505Updated Jan 29, 2021

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

An observational study in SCI - Spinal Cord Injury and Cardiovascular Risk Factor, sponsored by Paracelsus Medical University. Completed at 2 sites in Austria. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-29.

Sponsored by Paracelsus Medical University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
54
Ages
18 Years to 80 Years
Sex
All
01

Study 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

02

Conditions studied

  • SCI - Spinal Cord Injury
  • Cardiovascular Risk Factor
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

healthy participants, wheelchair users

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

metallic implanters, additional neurologic pathologies, pregnancy

04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
54 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

05

What researchers measure

Primary outcomes

  1. 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).

    Time frame: October 2017- June 2018

  2. Evaluation of echocardiography results between different study groups

    Evaluation of echocardiography comparing healthy individuals and patients using wheelchairs (three different groups).

    Time frame: October 2017- June 2018

06

Study locations

2 sites
  • Department of Neurology, Christian Doppler Klinik, Paracelsus Medical University Salzburg
    Salzburg, 5020, Austria
  • Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University
    Salzburg, 5020, Austria
07

Registry details

Key details

Study ID
NCT03352505
Lead sponsor
Paracelsus Medical University
Responsible party
Prof. Josef Niebauer M.D., Ph.D., MBA (Prof. Josef Niebauer, M.D., Ph.D, MBA, Paracelsus Medical University) — Principal investigator
First posted
Nov 24, 2017
Start date
Oct 1, 2017
Primary completion
Oct 1, 2019
Completion
Jan 28, 2021
Last update
Jan 29, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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