Cardiovascular DiseasesNCT03463486
Current Outpatient Cardiac Rehabilitation in Austria
An observational study of Cardiovascular Diseases, run by Paracelsus Medical University at 1 site in Austria.
Trial summary
Aim of this study is to give evidence to outpatient cardiac rehabilitation in Austria. The database created in this context is supposed to pave the way as instrument to document and comprehend quality of outpatient cardiac rehabilitation in Austria as a key for quality management. Read more about this study
- Who is it for?
- Ages 12 to 99 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Physical activity
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 8,000 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2005to Dec 2021
- How long will I take part?
- 1 Year
- 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 12 to 99 years
- All sexes
- Child, Adult, Older adult
Study population: Patients who qualified for an outpatient cardiac rehabilitation
Who may be able to join
- Any patient who meets inclusion criteria for outpatient cardiac rehabilitation in Austria -
Who cannot join
- Medical conditions which prevent patients from complying with the exercise program
- Acute infections
- Hypertrophic cardiomyopathy
- Pulmonary artery embolism or phlebothrombosis within the previous 6 months
- Unstable angina pectoris
- Heart failure (NYHA IV)
- Hemodynamically unstable arrhythmia
Trial locations and contacts
1 site in 1 country.
Austria1 site
Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University
Salzburg, 5020
About this study
Official title: Outpatient Cardiac Rehabilitation in Austria
Aim of this study is to give evidence to outpatient cardiac rehabilitation in Austria. The database created in this context is supposed to pave the way as instrument to document and comprehend quality of outpatient cardiac rehabilitation in Austria as a key for quality management. Analyses of the created database should be made on a regular basis.
- Conditions
- Cardiovascular Diseases
- Being tested
- Physical activity
- Keywords
- outpatient cardiac rehabilitation, exercise training,
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
50min of endurance training combined with 50min of calisthenics; 1-3x/wekk; 6weeks up to 1year
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Physical Work Capacity (PWC) in Phase II rehabilitation
PWC is measured by a graded exercise test on a cycle ergometer at start and end of outpatient cardiac rehabilitation
Measured: 6 weeks
Change from baseline in Physical Work Capacity (PWC) in Phase III rehabilitation
PWC is measured by a graded exercise test on a cycle ergometer at start and end of outpatient cardiac rehabilitation
Measured: 1 year
Secondary outcomes (6)
Change from baseline in Cholesterol in Phase II rehabilitation
Venous blood samples are taken to assess Cholesterol
Measured: 6 weeks
Change from baseline in Cholesterol in Phase III rehabilitation
Venous blood samples are taken to assess Cholesterol
Measured: 1 year
Change from baseline in Triglycerides in Phase II rehabilitation
Venous blood samples are taken to assess Triglycerides
Measured: 6 weeks
Change from baseline in Triglycerides in Phase III rehabilitation
Venous blood samples are taken to assess Triglycerides
Measured: 1 year
Change from baseline in Blood Glucose in Phase II rehabilitation
Venous blood samples are taken to assess blood glucose
Measured: 6 weeks
Change from baseline in Blood Glucose in Phase III rehabilitation
Venous blood samples are taken to assess blood glucose
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study startJan 2005
- Primary completionDec 2018
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,000 participants (actual)
- Target duration
- 1 Year
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
- Investigators
- Prof. Josef Niebauer, MD, PhD, MBA, Study chair, Institute of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University Salzburg, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463486
- Sponsor's protocol ID
- UISM-11
- Status last verified
- Apr 2022
- First submitted
- 17 Oct 2017
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Niebauer J, Hambrecht R, Velich T, Hauer K, Marburger C, Kalberer B, Weiss C, von Hodenberg E, Schlierf G, Schuler G, Zimmermann R, Kubler W. Attenuated progression of coronary artery disease after 6 years of multifactorial risk intervention: role of physical exercise. Circulation. 1997 Oct 21;96(8):2534-41. doi: 10.1161/01.cir.96.8.2534.
PubMed 9355890Adams V, Reich B, Uhlemann M, Niebauer J. Molecular effects of exercise training in patients with cardiovascular disease: focus on skeletal muscle, endothelium, and myocardium. Am J Physiol Heart Circ Physiol. 2017 Jul 1;313(1):H72-H88. doi: 10.1152/ajpheart.00470.2016. Epub 2017 May 5.
PubMed 28476924Niebauer J, Mayr K, Harpf H, Hofmann P, Muller E, Wonisch M, Pokan R, Benzer W. Long-term effects of outpatient cardiac rehabilitation in Austria: a nationwide registry. Wien Klin Wochenschr. 2014 Mar;126(5-6):148-55. doi: 10.1007/s00508-014-0527-3. Epub 2014 Mar 11.
PubMed 24615677
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Cardiac Rehabilitation in Austria
- ClinicalTrials.gov ID
- NCT03463486
- Acronym / sponsor ID
- UISM-11
- Conditions
- Cardiovascular Diseases
- Keywords
- outpatient cardiac rehabilitation, exercise training,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,000 participants (actual)
- Lead sponsor
- Paracelsus Medical UniversityUniversity, hospital or other
- Study start
- Jan 2005 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 13 Mar 2018 (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.
Aim of this study is to give evidence to outpatient cardiac rehabilitation in Austria. The database created in this context is supposed to pave the way as instrument to document and comprehend quality of outpatient cardiac rehabilitation in Austria as a key for quality management. Analyses of the created database should be made on a regular basis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 12 to 99 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who qualified for an outpatient cardiac rehabilitation
Key inclusion criteria (1 listed)
- Any patient who meets inclusion criteria for outpatient cardiac rehabilitation in Austria -
Key exclusion criteria (7 listed)
- Medical conditions which prevent patients from complying with the exercise program
- Acute infections
- Hypertrophic cardiomyopathy
- Pulmonary artery embolism or phlebothrombosis within the previous 6 months
- Unstable angina pectoris
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity50min of endurance training combined with 50min of calisthenics; 1-3x/wekk; 6weeks up to 1year | Behavioural | – |
Primary outcome
Change from baseline in Physical Work Capacity (PWC) in Phase II rehabilitation
Time frame: 6 weeks
PWC is measured by a graded exercise test on a cycle ergometer at start and end of outpatient cardiac rehabilitation
Change from baseline in Physical Work Capacity (PWC) in Phase III rehabilitation
Time frame: 1 year
PWC is measured by a graded exercise test on a cycle ergometer at start and end of outpatient cardiac rehabilitation
6 secondary outcomes
Change from baseline in Cholesterol in Phase II rehabilitation
Time frame: 6 weeks
Change from baseline in Cholesterol in Phase III rehabilitation
Time frame: 1 year
Change from baseline in Triglycerides in Phase II rehabilitation
Time frame: 6 weeks
Change from baseline in Triglycerides in Phase III rehabilitation
Time frame: 1 year
Change from baseline in Blood Glucose in Phase II rehabilitation
Time frame: 6 weeks
Change from baseline in Blood Glucose in Phase III rehabilitation
Time frame: 1 year
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 25 Apr 2022.
- Background: PubMed 9355890Niebauer J, Hambrecht R, Velich T, Hauer K, Marburger C, Kalberer B, Weiss C, von Hodenberg E, Schlierf G, Schuler G, Zimmermann R, Kubler W. Attenuated progression of coronary artery disease after 6 years of multifactorial risk intervention: role of physical exercise. Circulation. 1997 Oct 21;96(8):2534-41. doi: 10.1161/01.cir.96.8.2534.
- Background: PubMed 28476924Adams V, Reich B, Uhlemann M, Niebauer J. Molecular effects of exercise training in patients with cardiovascular disease: focus on skeletal muscle, endothelium, and myocardium. Am J Physiol Heart Circ Physiol. 2017 Jul 1;313(1):H72-H88. doi: 10.1152/ajpheart.00470.2016. Epub 2017 May 5.
- Results publication: PubMed 24615677Niebauer J, Mayr K, Harpf H, Hofmann P, Muller E, Wonisch M, Pokan R, Benzer W. Long-term effects of outpatient cardiac rehabilitation in Austria: a nationwide registry. Wien Klin Wochenschr. 2014 Mar;126(5-6):148-55. doi: 10.1007/s00508-014-0527-3. Epub 2014 Mar 11.
- Paracelsus Medical University Salzburg, AustriaLink provided by the sponsor.
- Institute of Sports Medicine, Prevention and RehabilitationLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
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.
Prof. Josef Niebauer, MD, PhD, MBA study chair
Institute of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University Salzburg, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Paracelsus Medical University at 1 site 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 7 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 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change from baseline in Physical Work Capacity (PWC) in Phase II rehabilitation (time frame: 6 weeks). 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?
On the ClinicalTrials.gov record for NCT03463486, which also lists 3 linked publications.
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 25 Apr 2022.