SCI - Spinal Cord InjuryNCT03352505
Cardiovascular Risk Markers in Spinal Cord Injured Subjects of the Wheelchair Dancer Study
An observational study of SCI - Spinal Cord Injury and Cardiovascular Risk Factor, run by Paracelsus Medical University at 2 sites in Austria.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- SCI - Spinal Cord Injury, Cardiovascular Risk Factor
- How many people
- 54 participants
- Where
- 2 sitesAustria
- Study dates
- 1 Oct 2017to 28 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy participants, wheelchair users
Who may be able to join
- wheelchair users independent of the cause of the walking impairment, preferably with spinal cord injury.
Who cannot join
- metallic implanters, additional neurologic pathologies, pregnancy
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
Department of Neurology, Christian Doppler Klinik, Paracelsus Medical University Salzburg
Salzburg, 5020
Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University
Salzburg, 5020
About this study
Official title: 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
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: October 2017- June 2018
Evaluation of echocardiography results between different study groups
Evaluation of echocardiography comparing healthy individuals and patients using wheelchairs (three different groups).
Measured: October 2017- June 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start1 Oct 2017
- Primary completion1 Oct 2019
- Study completion28 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCI - Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paracelsus Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Josef Niebauer M.D., Ph.D., MBA, Paracelsus Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352505
- Sponsor's protocol ID
- UISM-12
- Status last verified
- Jan 2021
- First submitted
- 16 Nov 2017
- Last updated
- 29 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations Between the Cardiovascular Risk Markers and Neuroplasticity in Sedentary or Physically Active Spinal Cord Injured Subjects of the Wheelchair Dancer Study
- ClinicalTrials.gov ID
- NCT03352505
- Acronym / sponsor ID
- UISM-12
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Paracelsus Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 28 Jan 2021 (actual)
- First posted
- 24 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy participants, wheelchair users
Key inclusion criteria (1 listed)
- wheelchair users independent of the cause of the walking impairment, preferably with spinal cord injury.
Key exclusion criteria (1 listed)
- metallic implanters, additional neurologic pathologies, pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SCI - Spinal Cord Injury and Cardiovascular Risk Factor, run by Paracelsus Medical University at 2 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of cardiovascular risk factors between different study groups (time frame: October 2017- June 2018). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021.